ArticleLiterature Review

Rhinitis 2020: A Practice Parameter Update

Authors:
  • The University of Chicago Medicine, Chicago, Illinois, United States
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Abstract

This comprehensive practice parameter for allergic rhinitis (AR) and nonallergic rhinitis (NAR) provides updated guidance on diagnosis, assessment, selection of monotherapy and combination pharmacologic options, and allergen immunotherapy for AR. Newer information about local AR is reviewed. Cough is emphasized as a common symptom in both AR and NAR. Food allergy testing is not recommended in the routine evaluation of rhinitis. Intranasal corticosteroids (INCS) remain the preferred monotherapy for persistent AR, but additional studies support the additive benefit of combination treatment with INCS and intranasal antihistamines in both AR and NAR. Either intranasal antihistamines or INCS may be offered as first-line monotherapy for NAR. Montelukast should only be used for AR if there has been an inadequate response or intolerance to alternative therapies. Depot parenteral corticosteroids are not recommended for treatment of AR due to potential risks. While intranasal decongestants generally should be limited to short-term use to prevent rebound congestion, in limited circumstances, patients receiving regimens that include an INCS may be offered, in addition, an intranasal decongestant for up to 4 weeks. Neither acupuncture nor herbal products have adequate studies to support their use for AR. Oral decongestants should be avoided during the first trimester of pregnancy. Recommendations for use of subcutaneous and sublingual tablet allergen immunotherapy in AR are provided. Algorithms based on a combination of evidence and expert opinion are provided to guide in the selection of pharmacologic options for intermittent and persistent AR and NAR.

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... However, this classification is not reliable since most patients are polysensitized, causing multiseason, or, in some locations, perennial problems, as indoor and outdoor allergen levels differ throughout the year and therefore affect sufferers episodically or year round [4]. Attributed to this, the Rhinitis 2020: A practice parameter update recommended that AR be classified according to severity ( [5]. Mild AR symptoms do not interfere with quality of life (QoL), and have no impact on daily activities, work or school performance, leisure activities and sleep; however, moderate/severe symptoms can be troublesome and negatively impact any or all of these aspects of daily life [5]. ...
... Attributed to this, the Rhinitis 2020: A practice parameter update recommended that AR be classified according to severity ( [5]. Mild AR symptoms do not interfere with quality of life (QoL), and have no impact on daily activities, work or school performance, leisure activities and sleep; however, moderate/severe symptoms can be troublesome and negatively impact any or all of these aspects of daily life [5]. They can significantly impact physical, social, emotional and mental aspects of life. ...
... The US Rhinitis practice parameter update supports a stepwise approach to treatment, which should consider relative effectiveness, onset of action, potential adverse effects, patient preference, cost, symptom severity and the presence of either intermittent or persistent AR [5]. AR symptom management in children is similar to that of adults, involving allergen avoidance, pharmacological treatments and allergen immunotherapy. ...
Article
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Allergic rhinitis (AR) is the most common undiagnosed chronic condition in children. Moderate/severe AR symptoms significantly impair quality of life, and cause sleep disruption, absenteeism and decreased productivity. Additionally, untreated AR predisposes children to asthma and other chronic conditions. Although intranasal corticosteroids are the most effective pharmacologic treatment for AR, oral antihistamines are often preferred. First-generation antihistamines may be chosen to relieve AR symptoms as they are inexpensive and widely available; however, they cause sedative and cardiovascular negative effects due to poor receptor selectivity. Therefore, second-generation antihistamines were developed to reduce adverse effects while retaining efficacy. There are fewer clinical trials in children than adults, therefore, efficacy and safety data is limited, particularly in children under 6 years, highlighting the need to generate these data in young children with AR. Fexofenadine, a highly selective second-generation antihistamine, effectively alleviates symptoms of AR, is non-sedating due to decreased blood–brain barrier permeability, and is devoid of cardiovascular side effects. Importantly, fexofenadine relieves the ocular symptoms of allergic conjunctivitis, which occur concomitantly with AR, improving quality of life. Overall, fexofenadine displays a favorable safety profile and results in greater treatment satisfaction in children compared with other second-generation antihistamines. This review aimed to evaluate and compare the safety and efficacy of fexofenadine with other available first- and second-generation antihistamines in children with AR.
... The commonest reason for nasal and sinus symptoms is AR, which can usually be diagnosed on the basis of history and examination. [11] However, a common problem in South Africa (SA) is that patients (both adults and children) are not adequately diagnosed with AR, and in the absence of a supportive allergy test or failed therapy, or if additional symptoms are not present, the more common conditions in the differential diagnosis of CRS are frequently missed. ...
... Topical use of saline or Ringer's lactate douching may be appropriate. Capsaicin may be an appropriate therapy, but is currently unavailable in SA. [11] Local AR Local AR is a common condition in which systemic allergy testing is negative. Testing should include nasal provocation testing, but this is not commonly available in SA. ...
... The SAARWG recognises the difficulty of excluding idiopathic rhinitis and local AR, and because these conditions are fairly common, a trial of AR therapy may be appropriate. [11] Primary immunodeficiency diseases PIDs are more prevalent than was previously thought. [14] More than 350 forms have now been described, and almost all of them may involve the upper airway. ...
Article
The term rhinitis implies inflammation of the lining of the nose. Characteristic symptoms are a blocked nose, anterior and posterior rhinorrhea, sneezing and itching. Not all cases of chronic rhinitis have an allergic basis. Chronic non-allergic rhinitis is defined as a condition where ongoing rhinitic symptoms are present for many months (as for persistent allergic rhinitis) but there is no IgE basis. Many common conditions may present as chronic rhinitis, which will need to be investigated and managed on their own merits. Not all cases of chronic rhinitis respond to allergic rhinitis therapy: continued attempts to manage chronic rhinitis as allergic rhinitis may be hampered by pathophysiological conditions where other specific therapy may be required. Chronic rhinitis impacts on patient quality of life, and therefore therapy is important. Managing patients with chronic rhinitis requires attention to patient education in order to achieve the maximal therapeutic benefit of medication. This update is intended to provide clinicians with a sound basis for management of a common condition.
... The most common symptoms of AR include nasal congestion, nasal pruritus, sneezing, and runny nose, leading to impairment in daily activities, sleep habits, cognitive function, work and school productivity, and overall quality of life [8,11,12]. Children with AR are more likely to have asthma, allergic conjunctivitis, rhinosinusitis, nasal polyposis, and otitis media [8]. ...
... A variety of treatment options for AR symptoms exist. The most commonly used pharmacotherapy for AR is oral antihistamines with a preference for second-generation antihistamines (e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) over first-generation antihistamines (e.g., diphenhydramine, hydroxyzine, chlorpheniramine) because of fewer side effects related to sedation, disrupted sleep, and anticholinergic symptoms [12,82]. Intranasal corticosteroids, which decrease the inflammatory cells and inhibit the release of cytokines, decreasing inflammation of the nasal mucosa, are recommended as the initial treatment for AR, as they have been found to be equally or more effective than oral antihistamines [12,82,83]. ...
... The most commonly used pharmacotherapy for AR is oral antihistamines with a preference for second-generation antihistamines (e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) over first-generation antihistamines (e.g., diphenhydramine, hydroxyzine, chlorpheniramine) because of fewer side effects related to sedation, disrupted sleep, and anticholinergic symptoms [12,82]. Intranasal corticosteroids, which decrease the inflammatory cells and inhibit the release of cytokines, decreasing inflammation of the nasal mucosa, are recommended as the initial treatment for AR, as they have been found to be equally or more effective than oral antihistamines [12,82,83]. Other pharmacologic treatment options for AR include intranasal corticosteroids, intranasal or ocular antihistamines, decongestants, intranasal cromolyn, intranasal anticholinergics, oral leukotriene receptor antagonists, and oral corticosteroids; however, intranasal cromolyn and decongestants are not always suitable for young children [82,83]. ...
Article
Full-text available
Environmental factors play an important role in the development and exacerbation of allergic rhinitis (AR) in childhood. Indoor air pollution, such as house dust mites and secondhand smoke, can significantly increase the onset of AR, while pet dander may affect the exacerbation of AR symptoms in children. Furthermore, traffic related air pollution and pollen are outdoor air pollutants that can affect immune competency and airway responsiveness, increasing the risk of AR in children. Climate change has increased AR in children, as growth patterns of allergenic species have changed, resulting in longer pollen seasons. More extreme and frequent weather events also contribute to the deterioration of indoor air quality due to climate change. Additionally, viruses provoke respiratory tract infections, worsening the symptoms of AR, while viral infections alter the immune system. Although viruses and pollution influence development and exacerbation of AR, a variety of treatment and prevention options are available for AR patients. The protective influence of vegetation (greenness) is heavily associated with air pollution mitigation, relieving AR exacerbations, while the use of air filters can reduce allergic triggers. Oral antihistamines and intranasal corticosteroids are common pharmacotherapy for AR symptoms. In this review, we discuss the environmental risk factors for AR and summarize treatment strategies for preventing and managing AR in children.
... The classical symptoms of AR are nasal obstruction due to mucosal swelling, itching, sneezing, rhinorrhoea and postnasal drip. 32 Athletes with allergies may also complain of associated ocular itching, erythema and/or tearing, oral cavity or pharyngeal pruritus, sore throat, aural itching or congestion, wheezing or cough and/or asthma. 32 A clinical diagnosis of AR is made when athletes present with a history consistent with an allergic cause and at least one of the classical symptoms. ...
... 32 Athletes with allergies may also complain of associated ocular itching, erythema and/or tearing, oral cavity or pharyngeal pruritus, sore throat, aural itching or congestion, wheezing or cough and/or asthma. 32 A clinical diagnosis of AR is made when athletes present with a history consistent with an allergic cause and at least one of the classical symptoms. 32 43 The diagnosis can be confirmed by determining serum IgE as a general indicator of allergies, and by performing skin prick testing or in vitro testing methods 32 43 for specific allergens. ...
... 13 It is important to note that, as in the general population, mixed rhinitis may occur in some athletes, that is, rhinitis symptoms that have both allergic and non-allergic components. 32 A diagnosis of a mixed rhinitis should be considered in cases where an athlete has an ineffective or partial response to medication. ...
Article
Acute respiratory illness (ARill) is common and threatens the health of athletes. ARill in athletes forms a significant component of the work of Sport and Exercise Medicine (SEM) clinicians. The aim of this consensus is to provide the SEM clinician with an overview and practical clinical approach to non-infective ARill in athletes. The International Olympic Committee (IOC) Medical and Scientific Committee appointed an international consensus group to review ARill in athletes. Key areas of ARill in athletes were originally identified and six subgroups of the IOC Consensus group established to review the following aspects: (1) epidemiology/risk factors for ARill, (2) infective ARill, (3) non-infective ARill, (4) acute asthma/exercise-induced bronchoconstriction and related conditions, (5) effects of ARill on exercise/sports performance, medical complications/return-to-sport (RTS) and (6) acute nasal/laryngeal obstruction presenting as ARill. Following several reviews conducted by subgroups, the sections of the consensus documents were allocated to ‘core’ members for drafting and internal review. An advanced draft of the consensus document was discussed during a meeting of the main consensus core group, and final edits were completed prior to submission of the manuscript. This document (part 2) of this consensus focuses on respiratory conditions causing non-infective ARill in athletes. These include non-inflammatory obstructive nasal, laryngeal, tracheal or bronchial conditions or non-infective inflammatory conditions of the respiratory epithelium that affect the upper and/or lower airways, frequently as a continuum. The following aspects of more common as well as lesser-known non-infective ARill in athletes are reviewed: epidemiology, risk factors, pathology/pathophysiology, clinical presentation and diagnosis, management, prevention, medical considerations and risks of illness during exercise, effects of illness on exercise/sports performance and RTS guidelines.
... Immunologically, allergy is caused by an exaggerated type 2 response to foreign antigens. However, many allergy-associated clinical syndromes have forms in which allergic sensitization cannot be demonstrated (49,50). In some cases, this might be due to primary dysregulation of type 2 inflammatory cells and mediators. ...
... For example, some patients with late-onset eosinophilic asthma are thought to have primary dysregulation of ILC2, which produce type 2 cytokines independent of antigenic stimulation (51). Patients with NARES (nonallergic rhinitis with eosinophilia syndrome) are thought to have a primary eosinophilic disorder in at least some cases (50). In other cases, non-type 2 mediators can promote symptoms that are clinically indistinguishable from allergen-specific type 2 responses. ...
Article
Full-text available
Autoinflammatory diseases are a group of clinical syndromes characterized by constitutive overactivation of innate immune pathways. This results in increased production of or responses to monocyte- and neutrophil-derived cytokines such as interleukin-1β (IL-1β), Tumor Necrosis Factor-α (TNF-α), and Type 1 interferon (IFN). By contrast, clinical allergy is caused by dysregulated type 2 immunity, which is characterized by expansion of T helper 2 (Th2) cells and eosinophils, as well as overproduction of the associated cytokines IL-4, IL-5, IL-9, and IL-13. Traditionally, type 2 immune cells and autoinflammatory effectors were thought to counter-regulate each other. However, an expanding body of evidence suggests that, in some contexts, autoinflammatory pathways and cytokines may potentiate type 2 immune responses. Conversely, type 2 immune cells and cytokines can regulate autoinflammatory responses in complex and context-dependent manners. Here, we introduce the concepts of autoinflammation and type 2 immunity. We proceed to review the mechanisms by which autoinflammatory and type 2 immune responses can modulate each other. Finally, we discuss the epidemiology of type 2 immunity and clinical allergy in several monogenic and complex autoinflammatory diseases. In the future, these interactions between type 2 immunity and autoinflammation may help to expand the spectrum of autoinflammation and to guide the management of patients with various autoinflammatory and allergic diseases.
... This article documents the evidence concerning AR prevalence and natural history, then provides management advice with an algorithm based on an update of existing guidelines (12)(13)(14)(15). Initially devised by GS and UW, using searches involving the terms "pediatric allergic rhinitis" and "allergic rhinitis in children" and "childhood rhinitis" each meshed with all possible therapies and with "education, " "prevention, " "development, " "outcomes, " "side effects, " and "safety, " this was then altered and adapted by the other authors until a final version was agreed. ...
... The EUFOREA algorithm (Figure 5) includes these and is based upon an update of previous evidence-based guidelines. It covers management of pediatric AR at all levels and of all severities (12)(13)(14)(15). ...
Article
Full-text available
Allergic rhinitis in childhood has been often missed, mistreated and misunderstood. It has significant comorbidities, adverse effects upon quality of life and educational performance and can progress to asthma or worsen control of existing asthma. Accurate diagnosis and effective treatment are important. The new EUFOREA algorithm provides a succinct but wide- ranging guide to management at all levels, based on previous guidelines with updated evidence and has been adjusted and approved by experts worldwide.
... [15][16][17] The control status of the disease is often associated with quality of life. 7,18 Quantifying work productivity loss and activity impairment can provide a better understanding of the impact of asthma and rhinitis control on the lives of patients. ...
... 7 Patients' comorbid rhinitis was diagnosed by the physician (GW), with a history of rhinitis or the presence of one or more of the following signs and/or symptoms: nasal congestion, rhinorrhea (anterior and posterior), sneezing, and nasal itching. 18,23,24 Patients who enrolled in this study were required to have a stable disease state. This study excluded patients if they were pregnant or breast-feeding; had a respiratory infection, asthma exacerbation, or change in maintenance therapy during the previous 4 weeks of screening; had other severe unstable chronic diseases; had lung cancer or other blood, lymphatic, or solid organ malignancy; or had other upper airway diseases, e.g., chronic sinusitis. ...
Article
Background: Symptomatic asthma and rhinitis negatively impact patients' work productivity and activity. However, little isknown about the potential interaction effect of both asthma and rhinitis control on work productivity and activity impairment. Objective: This study aimed to explore whether there are interaction effects of asthma and rhinitis control on work productivity and activity impairment in patients with asthma and with rhinitis. Methods: A total of 206 adult patients were prospectively recruited and were divided into four groups: both poorly controlled (BPC) (n = 53), poorly controlled asthma (PCA) with controlled rhinitis (CR) (n = 38), well controlled asthma with uncontrolled rhinitis (n = 43), and both well controlled (BWC) (n = 72) based on the symptom control status of asthma and rhinitis. Work productivity loss and activity impairment, asthma control, and rhinitis control were assessed by using work productivity and activity impairment questionnaire: general health, the asthma control test, and the rhinitis control assessment test, respectively. General linear regression models were used to study the contribution of asthma control, rhinitis control, and the interaction effect on work productivity and activity impairment. Results: Work productivity loss was most frequently reported in patients in the BPC group. Compared with the patients in theBWC group, the patients in the PCA-CR group had significantly higher activity impairment and worse asthma-related quality oflife (both p < 0.001). There were significant interaction effects of asthma and rhinitis control, which accounted for the increase in presenteeism, work productivity loss, and activity impairment (all p< 0.001). Although differences in absenteeism were not significant among the groups, there was a significant interaction effect of control levels accounted for absenteeism (p = 0.035). Conclusion: Distinct interaction effects of asthma and rhinitis control reflected a link between upper and lower airways, which indicated that rhinitis control and the interaction effects of asthma and rhinitis control cannot be neglected during asthma management.
... The incidence of rhinitis has been reported to harass 14% of adults and 13% of children in the United States. 1 Furthermore, rhinitis can coexist with asthma and usually is a strong risk factor for new-onset asthma, exerting a heavy burden on society. 2 Thus, it is necessary to identify the risk factors for rhinitis and control them. It has been reported that genetic factors might play an important role in the pathogenesis of rhinitis, together with those environmental factors. ...
... The Mendelian randomization analysis is performed based on the following 3 principles: 1 The genetic variant is closely associated with the exposure; 2 The genetic variant is not associated with potential confounders; 3 The genetic variant is not associated with the outcome except via the way of the exposure 7 (Fig. 1A). Usually, the first assumption can be well satisfied using the GWAS summary statistics and the last 2 assumptions sometimes cannot be well tested. ...
Article
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Background Allergic rhinitis and vasomotor rhinitis are harassing numerous patients and their risk factors have not been well investigated. Here, we try to identify their risk factors and distinguish these 2 diseases. Methods A two-sample Mendelian randomization (MR) study was implemented to discover the risk factors of allergic and vasomotor rhinitis. Based on previous studies, we selected 15 potential risk factors and the genome-wide summary statistics were extracted from the non-FinnGen consortium. The genome-wide summary statistics of rhinitis were obtained from the FinnGen consortium. Both univariable MR and multivariable MR analyses were performed to identify the causal risk factors. The Cochrane's Q value was calculated to appraise the heterogeneity. MR-Egger intercept and MR-RPESSO were utilized to appraise the pleiotropy. Results In the univariable model, the number of cigarettes per day can decrease the risk of allergic rhinitis (IVW OR = 0.29[0.18, 0.47], p-value = 2.70 × 10⁻⁷) while increasing the risk of vasomotor rhinitis (IVW OR = 1.30[1.04, 1.62], p-value = 0.022). Besides, no other risk factors could affect the risk of either allergic or vasomotor rhinitis. After adjusting for age of smoking initiation and alcohol intake, the cigarettes per day could still decrease the risk of allergic rhinitis (IVW OR = 4.66 × 10⁻³ [1.99 × 10⁻⁴, 0.11], p-value = 0.003) while not affecting the risk of vasomotor rhinitis (IVW OR = 0.92[0.44, 1.96], p-value = 0.834). Conclusion Smoking can affect the risk of allergic and vasomotor rhinitis differently where it decreases the risk of allergic rhinitis and increases the risk of vasomotor rhinitis.
... There are two main types of allergic rhinitis, namely seasonal (also known as intermittent) and perennial (also known as persistent) allergic rhinitis [4] . ...
... Several studies have found a strong association between mold exposure and childhood asthma [9] . A 2013 retrospective analysis examined the association between mold exposure and allergic rhinitis and found that exposure to dampness and mold was associated with allergic reactions including allergic rhinitis [4] . These results suggest that preventing indoor dampness and reducing mold may reduce the risk of developing allergic rhinitis. ...
Preprint
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OBJECTIVE: To investigate the risk factors associated with allergic rhinitis in adults. METHODS: Using the 1:1 matching principle, 1096 cases of allergic rhinitis patients aged 18-65 years were selected as the observation group, and another group of healthy medical checkups were selected as the control group, and the data related to allergic rhinitis were collected by allergen testing and questionnaire survey, and univariate and multifactorial analyses were performed respectively. RESULTS: The univariate analysis showed that allergic rhinitis may be related to temperature changes, dryness and humidity, air pressure, wind speed, seasonal changes and exposure to allergens such as dust mites and house dust mites. After allergen testing of all patients in the observation group, it was found that dust mite and house dust mite were the highest percentage of allergens, accounting for 40.51%, indicating that environmental factors play a decisive role in allergic rhinitis. Multi-factor analysis showed that exposure to dust mites, house dust mites, Penicillium punctatum, Streptomyces crossatus and Aspergillus fumigatus were independent risk factors for allergic rhinitis when it was humid, when it was cold, when it was windy and when the air pressure was low. CONCLUSION: The epidemiological status of allergic rhinitis in adults in China was initially understood, and the main allergens were house dust mite and dust mite, which provided scientific epidemiological information for the standardized prevention and treatment of allergic rhinitis in this region.
... Rhinitis is a heterogeneous diagnosis characterized by the presence of one or more nasal symptoms, such as congestion, rhinorrhea, sneezing, and itching [1][2][3]. Traditionally, rhinitis cases have been divided by the presence (or absence) of an underlying allergy trigger, categorized as either allergic or non-allergic. Allergic rhinitis (AR) is a condition where IgE-mediated hypersensitivity of the nasal mucosa occurs following an identified allergen exposure. ...
... The social burden imposed by rhinitis is substantial. As many as one in three US adults self-report a diagnosis of AR [9], while NAR might impact as many as 200 million adults worldwide [2,10]. ...
Article
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Purpose of Review Rhinitis is a heterogeneous diagnosis characterized by the presence of several nasal symptoms and it is only when pharmacotherapy fails that surgical treatment is considered. Over the years, multiple surgical techniques and approaches have been proposed to treat these patients. We aim to present a comprehensive literature review of the surgical management of rhinitis, including the most recent techniques and long-term outcome evaluations. Recent Findings Endoscopic techniques targeting the inferior turbinates, septum, and the parasympathetic neural supply to the nasal mucosa have evolved over the years to surgically address rhinitis; better understanding of rhinitis physiopathology has prompted the development of less invasive techniques with potentially similar outcomes and decreased morbidity. Summary For the management of allergic rhinitis, isolated outfracture of the inferior turbinate remains the least invasive technique and classical submucosal resection remains very much in favor among practitioners. A variety of methods to achieve adequate submucosal reduction of the inferior turbinate are also discussed, including the microdebrider, radiofrequency ablation, and coblation techniques. Regarding non allergic rhinitis, we assess both endoscopic vidian neurectomy and posterior nasal nerve neurectomy, two broadly effective, but elaborate, options necessitating general anesthesia and a visit to the operating room. We also discuss cryoablation of the posterior nasal nerve, which presents as a minimally invasive technique that can be performed as an in-office procedure.
... 5 Despite the existence of AR treatment guidelines, their 191 indications appear to be insufficiently followed by patients. 6 Patients increase their medications when 192 needed in order to control their symptoms. 7,8 However, the seasonality and patterns of co-medication have ...
Article
Background: Co-medication is common among patients with allergic rhinitis (AR), but its dimension and patterns are unknown. This is particularly relevant since AR is understood differently across European countries, as reflected by rhinitis-related search patterns in Google Trends. This study aims to assess AR co-medication and its regional patterns in Europe, using real-world data. Methods: We analysed 2015-2020 MASK-air® European data. We compared days under no medication, monotherapy, and co-medication using the visual analogue scale (VAS) levels for overall allergic symptoms ("VAS Global Symptoms") and impact of AR on work. We assessed the monthly use of different medication schemes, performing separate analyses by region (defined geographically or by Google Trends patterns). We estimated the average number of different drugs reported per patient within one year. Results: We analysed 222,024 days (13,122 users), including 63,887 days (28.8%) under monotherapy, and 38,315 (17.3%) under co-medication. The median "VAS Global Symptoms" was 7 for no medication days, 14 for monotherapy and 21 for co-medication (p<0.001). Medication use peaked during the spring, with similar patterns across different European regions (defined geographically or by Google Trends). Oral H1 -antihistamines were the most common medication in single and co-medication. Each patient reported using an annual average of 2.7 drugs, with 80% reporting two or more. Conclusions: AR medication patterns are similar across European regions. One third of treatment days involved co-medication. These findings suggest that patients treat themselves according to their symptoms (irrespective of how they understand AR), and that co-medication use is driven by symptom severity.
... Таким образом, согласно текущему уровню знаний ИнГКС используются при следующих заболеваниях ВДП с различными воспалительными механизмами: АР, НАР, особенно НАР с эозинофильным синдромом, ОРС, ХРС с назальными полипами и без них, аденоидная гипертрофия и ринит при бронхиальной астме [67]. ...
Article
Rhinitis is one of the most common diseases and this term is used as an umbrella diagnosis for patients with different clinical phenotypes of the disease (allergic, non-allergic, infectious, etc.). Recognizing the high socio-economic burden of the disease and complexities of choosing an optimal therapy, it is important to focus on interdisciplinary interactions, which are reflected in modern clinical guidelines created by experts from ARIA, EAACI, EPOS, as well as national and professional societies. Patients with rhinitis symptoms often self-medicate, use the advice of pharmacist, receive recommendations from general practitioners in outpatient practice, and very few patients get specialists (ENT or allergist-immunologist) advice; herefore, in many cases, optimal criteria for disease control (symptoms, quality of life, objective measurements) cannot be achieved. Currently international professional communities have developed innovative therapeutic approaches based on knowledge of the phenotypes/endotypes of rhinitis to achieve such a control. Physicians in both primary and specialized care are encouraged to use step therapy. This approach to treatment is based on the control of disease symptoms, and intranasal corticosteroids (InGCS) are considered to be the most effective anti-inflammatory drugs for long-term control of rhinitis, especially in moderate-severe/severe cases. This well-proven efficacy of InGCS and their advantages over other classes of drugs make them the first-line therapy in the treatment of allergic rhinitis (evidence level A), as well as the drugs of choice for non-allergic rhinitis and rhinosinusitis. This review discusses fluticasone propionate, one of the in-demand InGCS, which has been the cornerstone of the treatment of allergic rhinitis for many years.
... Rhinitis is a heterogeneous group of inflammatory disorders of the nasal mucosa, characterized by the presence of several symptoms, including rhinorrhea, sneezing, nasal obstruction, and itching, variously associated [13]. Based on the etiology, rhinitis can be mainly subdivided into infectious, inflammatory, vasomotor, medicamentous, hormonal, occupational, and atrophic [14]. ...
Article
Mast cells (MCs) are involved in several biological processes, such as defense against pathogens, immunomodulation, tissue repair after injury, and angiogenesis. MCs have been shown to change from protective immune cells to potent pro-inflammatory cells, influencing the progression of many pathological conditions, including autoimmune diseases and cancers. The role of MCs in the pathogenesis of rhinopathies has often been underestimated, since previous studies have focused their attention on eosinophils and neutrophils, while MCs were considered involved exclusively in allergic rhinitis. However, recent nasal cytology findings have shown the involvement of MCs in several rhinopathies, such as NARMA, NARESMA, and CRSwNP. These recent evidences highlight the crucial role that MCs play in orchestrating the inflammation of the nasal mucosa, through complex biological mechanisms, not yet fully understood. In this context, a better understanding of these mechanisms is fundamental for practicing Precision Medicine, which requires careful population selection and stratification into subgroups based on the phenotype/endotype of the patients, in order to guarantee the patient a tailored therapy. Based on this background, further studies are needed to understand the pathophysiological mechanisms involving MCs and, consequently, to develop targeted therapies aimed to obtain a selective inhibition of tissue remodeling and preventing MC-mediated immune suppression.
... Contemporary therapy of LAR is based on well-known strategies for treating AR, relying on the immune and clinical similarities of these two phenotypes [1,5,47,48]. Considering that avoiding causative allergens is difficult to implement in practice and that there is not official recommendations for AIT, treatment relies on patient education and pharmacological therapy. ...
Article
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Local allergic rhinitis is a new rhinitis phenotype characterized by symptoms similar to allergic rhinitis, in non-atopic patients with a positive nasal allergen provocation test (NAPT). The disease is diagnosed in over 25% of non-atopic patients with rhinitis, marked as non-atopic rhinitis. It most often has perennial and severe symptoms and a progressive course. It is often associated with conjunctivitis and/or asthma. It is necessary to consider local allergic rhinitis in patients with non-atopic rhinitis. The gold standard for diagnosis is positive NAPT. Pharmacological therapy fails to stop the natural progression and development of comorbidities. Allergen immunotherapy reduces the symptoms, consumption of medicines and increases the tolerance to allergens responsible for local allergic rhinitis. New studies are needed to confirm curative and evaluate the preventive effects of allergen immunotherapy.
... Multiple reports assessing nasal irrigation have demonstrated its effectiveness in treating seasonal allergic rhinitis in adult and pediatric patients [24][25][26]. Seawater nasal irrigation, as utilized in the present trial, represents a simple method with high reproducibility and facile execution. Therefore, the study participants performed nasal irrigation without reserve. ...
Article
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BACKGROUND The purpose of this study was to assess the effects of seawater on nasal congestion and runny nose symptoms in adults with an acute upper respiratory infection (URI). MATERIAL AND METHODS This was a multicenter retrospective cohort trial of patients with acute URI and symptoms of nasal congestion and runny nose. The patients were assigned to 2 groups and were administered regular non-drug supportive treatment or supportive treatment with nasal irrigation with sea salt-derived physiological saline. The primary efficacy endpoint was the effective rate (percentage of patients with ≥30% symptom score reduction from baseline for nasal congestion and runny nose). RESULTS In total, 144 patients were enrolled, including 72 in each group, and 143 patients completed the study. Both groups had similar demographics and vital signs. The effective rates for nasal congestion and runny nose were significantly increased in the seawater group compared with patients in the control group (87.3% vs 59.7% for nasal congestion; 85.9% vs 61.1% for runny nose; both P<0.001). In addition, the 2 groups showed markedly different degrees of patient symptom score improvement in sleep quality and appetite (both P<0.01), but not in cough and fatigue (both P>0.05). There were no adverse events in either group. CONCLUSIONS The sea salt-derived physiological saline nasal spray device satisfactorily improved nasal congestion, runny nose, sleep quality, and appetite in adults with URI, with no adverse effects.
... Rhinitis caused by allergens and mediated by IgE is called allergic rhinitis (AR) (Passali et al., 2018;Jungewelter et al., 2020). Additionally, some of the anatomical abnormalities, presence of foreign bodies in the upper airways, nasal polyps, primary ciliary dyskinesia can be manifested in the same way, therefore rhinitis demand a careful diagnosis (Hellings et al., 2017;Dykewicz et al., 2020). Similarly to rhinitis, asthma is an umbrella term. ...
Article
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Respiratory allergy is a common disease with an increased prevalence worldwide. The effective remedy is still unknown, and a new therapeutic approach is highly desirable. The review elaborates the influence of probiotic bacteria on respiratory allergy prevention and treatment with particular emphasis on the impact of the current methods of their administration – oral and intranasal. The background of the respiratory allergy is complex thus, we focused on the usefulness of probiotics in the alleviation of different allergy factors, in particular involved in pathomechanism, local hypersensitive evidence and the importance of epithelial barrier. In this review, we have shown that (1) probiotic strains may vary in modulatory potential in respiratory allergy, (2) probiotic bacteria are beneficial in oral and intranasal administration, (3) recombinant probiotic bacteria can modulate the course of respiratory allergy.
... A study reported that the prevalence of self-reported AR in 11 Chinese cities ranges from 10 to 20% [3]. Classic symptoms of AR include rhinorrhea, nasal obstruction, nasal itching, and sneezing [4]. Comorbidities vary often, include sinusitis and asthma, have a significant impact on a person's quality of life, and are associated with sleep disorders, emotional problems, and social functioning [5,6]. ...
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Background Allergic rhinitis (AR) is an immunoglobulin E (IgE)-mediated inflammatory response. Persistent allergic rhinitis (PAR) is a subtype of AR, but the treatment of PAR is still a problem. Acupuncture is used as an alternative therapy for AR in clinical practice. The aim of this study is to evaluate the effectiveness of acupuncture therapy combined with fluticasone propionate nasal spray in comparison to fluticasone propionate nasal spray alone in the relief of symptoms for PAR. Methods This study is a multicenter, single-blind, randomized controlled trial. A total of 260 eligible patients will be randomly assigned into the treatment group or the control group. The treatment group will receive the nasal fluticasone propionate combined with acupuncture, and the control group will receive fluticasone propionate nasal spray alone for 6 weeks. The primary outcome is the change in the Reflective Total Nasal Symptom Score (rTNSS) from baseline to the end of treatment, and the Total Non Nasal Symptom Score (TNNSS), reflective total ocular symptom score (rTOSS), Rhinitis Quality of Life Questionnaire (RQLQ), use of antiallergic drugs, and the Rhinitis Control Assessment Test (RCAT) are used as secondary outcomes. The participants will be followed up for another 24 weeks after treatment. Discussion This clinical trial will be able to provide high level evidence on the acupuncture therapy combined with fluticasone propionate nasal spray in the treatment of PAR. Trial registration ISRCTN Registry, ID: ISRCTN44040506 . Registered on 22 July 2020.
... Allergy immunotherapy (AIT) delivered either by subcutaneous injection (SCIT) or sublingual tablets is a recommended treatment for AR/C [7]. Unlike symptom-relieving medications, AIT is diseasemodifying with persisting effects and the potential to prevent the development of allergic asthma in children [8,9]. ...
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Background: Post hoc analyses of randomized placebo-controlled trials have demonstrated efficacy and tolerability of the ragweed sublingual immunotherapy (SLIT)-tablet in Canadian adults with ragweed pollen-induced allergic rhinitis/conjunctivitis (AR/C). This post hoc analysis evaluated the efficacy and tolerability of the ragweed SLIT-tablet in the subpopulation of Canadian children and adolescents with AR/C in a previously described randomized, double-blind, placebo-controlled trial. Methods: The trial (NCT02478398) was conducted in North American and European children/adolescents ages 5-17 years with ragweed pollen-induced AR/C with or without asthma (FEV1 ≥ 80% predicted). Participants were randomized to daily ragweed SLIT-tablet (12 Amb a 1-U) or placebo for up to 28 weeks. The primary endpoint was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary endpoints were TCS during the entire RPS, and DSS and DMS during peak RPS. Post hoc analyses of the primary and key secondary endpoints were conducted in the subpopulation of Canadian participants. Results: Of the 1025 randomized participants, 246 (SLIT-tablet, n = 116; placebo, n = 130) were in the Canadian subpopulation. In the total study population, relative TCS (95% CI) improvement with ragweed SLIT-tablet versus placebo was - 38.3% (- 46.0%, - 29.7%; least square [LS] mean difference, - 2.73; P < 0.001) during peak RPS. In the Canadian subpopulation, relative TCS improvements with ragweed SLIT-tablet versus placebo were - 40.8% (- 54.5%, - 20.2%; LS mean difference, - 1.59; P = 0.001) during peak RPS and - 36.6% (- 50.2%, - 16.5%; LS mean difference, - 1.36; P = 0.002) during the entire RPS. DSS and DMS during peak RPS in the Canadian subpopulation improved with SLIT-tablet versus placebo by - 30.6% (- 45.2%, - 7.7%; LS mean difference, - 0.94; P = 0.010) and - 77.2% (- 97.5%, - 44.2%; LS mean difference, - 0.66; P = 0.003), respectively. No events of anaphylaxis, airway compromise, intramuscular epinephrine administration, eosinophilic esophagitis, or severe treatment-related systemic allergic reactions were reported in the overall population or Canadian subpopulation. Conclusion: Efficacy and safety of the ragweed SLIT-tablet in Canadian children/adolescents with ragweed pollen-induced AR/C was consistent with the total study population. The ragweed SLIT-tablet resulted in clinically meaningful improvement in symptoms, decreased symptom-relieving medication use, and was well tolerated in Canadian children/adolescents. Trial registration: clinicaltrials.gov, NCT02478398. Registered June 23, 2015, https://clinicaltrials.gov/ct2/show/NCT02478398?term=NCT02478398&draw=2&rank=1.
... Binding of histamine to H 1 receptors leads to symptoms of an acute allergic reaction such as itching, sneezing, and increased vascular permeability [2]. Thus, H 1 antihistamines are a standard treatment for histamine-mediated allergic reactions (i.e., allergic rhinitis, urticaria) [5][6][7]. ...
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Since 1955, the only available H1 antihistamines for intravenous administration have been first-generation formulations and, of those, only intravenously administered (IV) diphenhydramine is still approved in the USA. Orally administered cetirizine hydrochloride, a second-generation H1 antihistamine, has been safely used over-the-counter for many years. In 2019, IV cetirizine was approved for the treatment of acute urticaria. In light of this approval, this narrative review discusses the changing landscape of IV antihistamines for the treatment of histamine-mediated conditions. Specifically, IV antihistamines will be discussed as a treatment option for acute urticaria and angioedema, as premedication to prevent infusion reactions related to anticancer agents and other biologics, and as an adjunct treatment for anaphylaxis and other allergic reactions. Before the development of IV cetirizine, randomized controlled trials of IV antihistamines for these indications were lacking. Three randomized controlled trials have been conducted with IV cetirizine versus IV diphenhydramine in the ambulatory care setting. A phase 3 trial of IV cetirizine 10 mg versus IV diphenhydramine 50 mg was conducted in 262 adults who presented to the urgent care/emergency department with acute urticaria requiring antihistamines. For the primary efficacy endpoint, defined as change from baseline in a 2-h patient-rated pruritus score, non-inferiority of IV cetirizine to IV diphenhydramine was demonstrated (score - 1.6 vs - 1.5, respectively; 95% CI - 0.1, 0.3). Compared with IV diphenhydramine, IV cetirizine demonstrated fewer adverse effects including less sedation, a significantly shorter length of stay in the treatment center, and fewer returns to the treatment center at 24 and 48 h. Similar findings were demonstrated in another phase 2 acute urticaria trial and in a phase 2 trial assessing IV cetirizine for pretreatment for infusion reactions in the oncology/immunology setting. IV cetirizine is associated with similar patient outcomes, fewer adverse effects, and increased treatment center efficiency than IV diphenhydramine.
... Factors that have been associated with increased prevalence that will be discussed in more detail later include climate change, polluted urban areas, diet, and the microbiome among others. Diagnosis can be made on history and physical exam alone but oftentimes laboratory and/or skin tests can confirm the diagnosis [20]. ...
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Purpose of Review To summarize the most up-to-date literature on allergic diseases with an emphasis on understanding the increase in prevalence of allergic diseases. Recent Findings As atopy continues to rise, there is increasing evidence that genetic factors in addition to environmental factors contribute to the development of allergic disease. There is research to support that worsening air pollution and climate change as well as lifestyle changes such as an increase in saturated fats and sugars in the diet, antibiotic use, changes in the gut microbiome, and a shift towards a more sterile, more urbanized environment could all increase the likelihood of developing allergic diseases. Summary While the options available for management of allergic diseases are increasing and improving, the prevalence of allergic disease continues to rise. Further investigation of how we can influence the changes in our environment leading to increases in atopy as well as the genetics involved is crucial in order to prevent the development of allergic diseases.
... Allergic rhinitis (AR) is a common chronic childhood disease with a low rate of diagnosis causing poor quality of life, missed school days, decreased school performance, and significant direct and indirect healthcare cost [1]. Rhinitis adversely impacts the quality of life through sleep disturbance; resulting daytime sleepiness and fatigue; irritability; poor physical health and limited social functioning; and attention deficits [2]. AR, one of the two major categories of rhinitis, is characterized by IgE mediated type-1 hypersensitivity reaction to a sensitized allergen. ...
Article
Background Allergic rhinitis is a common chronic childhood disease with a low diagnosis rate, causing poor quality of life, absenteeism, decreased school performance and significant healthcare cost. However, data on the prevalence of allergic rhinitis is sparse in preschoolers of rural geography, especially in developing countries. Aim To describe the epidemiology of allergic rhinitis in preschoolers from a rural geography of a developing country. Methods A population-based cross-sectional study was conducted in Anuradhapura district, Sri Lanka using the WHO-30 cluster methodology with probability proportionate to size sampling. The International Study of Asthma and Allergy in Childhood questionnaire was used to assess symptomatology. Results The response rate was 91.8%, with 548 (51.7%) male and 512 (48.3%) female participants. The mean age was 4.4 (± 0.7) years. Allergic rhinitis was reported in 123 (11.6%; 95% CI 9.7–13.5), and eye symptoms were reported in 41 (3.9%; 95% CI 2.8–5.2) children. Activities of daily living were disturbed due to nasal symptoms in 113 (10.7%; 95% CI 8.8–12.5). Allergic rhinitis was independently associated with severe asthma (OR 6.26; 95% CI 3.54–11.06), sleeping on the floor (OR 4.79; 95% CI 1.33–17.25) and having cats in the households (OR 1.86; 95% CI 1.18–2.91). Nasal symptoms were more common in January and August to October months. The standardized local highest monthly temperature, lowest monthly temperature, highest monthly humidity and dew point strongly predicted allergic rhinitis symptom exacerbation (F=4.8, p=0.036, adjusted R square=57.8%, VIF≤2.259, DW=2.1). Conclusions Allergic rhinitis affects 1 in 10 preschool children of rural Sri Lanka. The factors associated and environmental factor model developed to predict symptom exacerbation could be used to prevent allergic rhinitis exacerbations.
Article
Pharmacotherapy for allergic rhinitis is based on different categories of drugs used either in monotherapy or in combination regimens. The current clinical guidelines suggest a stepwise approach to pharmacotherapy for allergic rhinitis. The use of intranasal corticosteroids is considered as the preferred second-stage pharmacotherapy. Inadequate control of AR symptoms in first-line therapy is a common problem. Integrated care pathways (ICP), developed taking into account the data obtained about patients using a mobile application, suggest the use of intranasal corticosteroids as the first line of therapy, including in patients with intermittent rhinitis who have not previously received treatment when assessing the condition according to the VAS for more than 5 points, in patients who received earlier treatment when assessing the condition according to the VAS less than 5 points. According to the data in the medical decision support system and continuing medical education UpToDate, inhaled corticosteroids are considered as the first-line drugs for the pharmacotherapy of allergic rhinitis. In terms of pharmacodynamic efficacy, intranasal corticosteroids are comparable to each other. The selection criteria can be considered: the value of systemic absorption; lipophilicity; the start time of the action; frequency of introduction, organoleptic properties; the possibility of influencing non-nasal symptoms. The use of sprays containing both a glucocorticoid and an antihistamine (mometasone furoate/azelastine hydrochloride) opens up additional pharmacotherapeutic possibilities in the treatment of allergic rhinitis.
Article
Background Air pollution may induce or reinforce nasal inflammation regardless of allergy status. There is limited direct clinical evidence informing the treatment of airborne pollution-related rhinitis. Objective To assess the effectiveness of intranasal budesonide in adults with self-reported rhinitis symptoms triggered/worsened by airborne pollution. Methods Adults in northern China with self-reported rhinitis symptoms triggered or worsened by airborne pollution were randomized to budesonide 256 µg/day or placebo for 10 days in pollution season (October 2019 to February 2020). The primary endpoint was the mean change from baseline in 24-h reflective total nasal symptom score (rTNSS) averaged over 10 days. The secondary endpoints were subject-assessed Global Impression of Change (SGIC), mean change from baseline in individual nasal symptom severity, and mean change from baseline in individual non-nasal symptoms of cough and postnasal drip severity. One-sided P < 0.0125 was considered statistically significant. Results After an interruption by COVID-19, an interim analysis showed that the study could be ended for efficacy with n = 206 participants (103/group) since the primary efficacy endpoint demonstrated significant results. The final efficacy results showed that the 10-day-averaged rTNSS change in the budesonide group was greater than with placebo (− 2.20 vs − 1.72, P = 0.0107). Budesonide also significantly improved 10-day-averaged itching/sneezing change (− 0.75 vs − 0.51, P = 0.0009). Results for SGIC and all other individual symptoms did not show significant differences between the two groups. Conclusions Intranasal budesonide 256 µg once daily improved the total nasal symptoms and itching/sneezing over 10 days in adults with rhinitis triggered/worsened by airborne pollution.
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Inflammatory and infectious upper respiratory diseases (IURDs; ICD-10: J30-J39), such as diseases of sinonasal tract, pharynx and larynx, are growing health problems yet their genomic similarity is not known. We analyzed genome-wide association to eight IURDs (61,195 cases) among 260,405 FinnGen participants, meta-analyzing diseases in four groups based on an underlying genetic correlation structure. We aimed to understand which genetic loci contribute to susceptibility to IURDs in general and its subtypes. We detected 59 independent genome-wide significant (GWS) loci, distinguishing impact on sinonasal or pharyngeal diseases, or both. Fine-mapping implicated non-synonymous variants in 16 genes, including 10 linked to immune-related diseases. Phenome-wide analysis implicated asthma and atopic dermatitis at sinonasal disease loci and inflammatory bowel diseases, and other immune-mediated disorders at pharyngeal disease loci. IURDs also genetically correlated with autoimmune diseases such as rheumatoid arthritis, autoimmune hypothyroidism, and psoriasis. Finally, we associated separate gene pathways in sinonasal and pharyngeal diseases that both contribute to type 2 immunological reaction. We show shared heritability among IURDs that extends to several immune-mediated diseases with diverse mechanisms, such as type 2 high inflammation.
Article
Allergy is a broad topic encompassing common clinical allergic diseases, asthma, and complex immunodeficiencies. In this article, the authors discuss the most common allergic diseases and anaphylaxis and briefly review the current knowledge and management of food allergies, allergic rhinitis, otitis media, sinusitis, chronic cough, atopic dermatitis, urticarial and angioedema, contact dermatitis, allergic ophthalmopathy, drug allergy, latex allergy, and insect sting. Because the prevalence of allergic disorders continues to increase, it is increasingly important for physicians to stay up to date on most recent evidence-based diagnosis and management of allergic disorders.
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Background Acupuncture and moxibustion have been widely applied in treating allergic rhinitis (AR). However, there is a lack of evidence-based guidelines for acupuncture and moxibustion for AR, thus we started a project on developing an international clinical practice guideline (CPG) for acupuncture and moxibustion for AR (WFASRP202001-SC05) approved by the World Federation of Acupuncture-Moxibustion Societies (WFAS). This study aims to formulate the clinical questions and important outcomes for this guideline. Methods Based on the principle of the WFAS standardization committee, multiple methods including the International PICO question survey, Delphi survey, and consensus conference of guideline development group (GDG) were applied. International PICO questionnaires widely gathered the demands from the target population. Then GDG selected clinical questions and important outcomes for the guideline via a mixed method of Delphi survey and consensus conference. Results 15 potential clinical questions and 10 sorts of outcomes were formulated under the supervision of a guideline steering group based on the analysis of 123 pieces of feedbacks from 17 countries of 5 continents. After 2 rounds of the Delphi survey, the consensus was reached in GDG that all of the potential questions were included. After 3 rounds of the Delphi survey, the consensus was reached that 9 of these outcomes were considered important outcomes. Conclusion 15 clinical questions and 9 important outcomes were selected for the CPG for acupuncture and moxibustion for AR. Since there has not established a standard method in formulating the clinical questions and important outcomes for CPGs in acupuncture and moxibustion, this one will be a useful reference.
Article
The FDA became aware of post-marketing reports of neuropsychiatric adverse events with Singulair (montelukast) use in 2007. Over the years, the Food and Drug Administration (FDA) has conducted reviews of the clinical trial safety data, focused analyses of post-marketing reports, and reviews of the published literature. These activities have resulted in successive labeling updates and public communications. However, there has been continued concern among stakeholders about the risk of neuropsychiatric events and the lack of awareness among prescribers and patients/caregivers. Based upon these concerns, FDA embarked on another comprehensive review and also conducted a new observational study using claims data in the Sentinel Distributed Database. In September 2019, FDA held a public Advisory Committee meeting to discuss its review and solicit recommendations from the panel regarding labeling and communication strategies. After careful consideration of the available data and feedback received during the FDA Advisory Committee meeting, the FDA required a boxed warning and a revision specifically for the allergic rhinitis indication to reserve use of montelukast to patients who have an inadequate response or intolerance to alternative therapies. Based upon benefit-risk considerations, the asthma indication was not changed. To provide insight into the process and rationale for the required labeling changes, we provide an overview of the decision-making framework we utilized.
Article
Acute respiratory diseases are one of the most common reasons for visiting a doctor in pediatric practice. Most episodes of this pathology have a viral etiology, signs of inflammation from the upper respiratory tract and proceed with symptoms of acute rhinitis (acute nasopharyngitis). The most of episodes of acute rhinitis last no more than 10 days and end with the patient’s recovery. The most common complications of acute rhinitis in children are acute rhinosinusitis and acute otitis media. These diseases are often mild and rarely have complications. However, a large number of patients with acute respiratory diseases increases the likelihood of a situation in which the doctor will encounter a problem patient. The article proposes care pathways for practitioners to manage patients with acute rhinological symptoms lasting up to 10 days and from 10 days to 3 months. The care pathways are based on several key points. No1: each patient must be analyzed for the presence of alarming symptoms, upon detection of which the patient should be urgently hospitalized. No2: all patients should be dynamically observed by a doctor until complete recovery, the patient should not receive treatment without the supervision of a doctor. No3: the basis of treatment is drugs for symptomatic therapy, which are selected depending on the dominant symptom that has the greatest impact on the patient’s well-being. To eliminate nasal mucosal edema, it is rational to use nasal decongestants (original oxymetazoline) for children of all ages; the course and dosages are determined according to the age of the child. Antibacterial drugs should be prescribed strictly according to indications in the presence of convincing data for the bacterial etiology of the disease.
Article
The authors presented an overview of the existing data on inhalation therapy with antibacterial drugs in acute rhinosinusitis and exacerbation of chronic rhinosinusitis in children. The overview includes general information about the etiology and features of the course of acute rhinosinusitis. It also contains indications for systemic and topical antibiotic therapy in acute rhinosinusitis specified in the Russian clinical guidelines. The advantages of using a combination preparation of thiampheni-col and N-acetylcysteine by inhalation therapy for acute rhinosinusitis in children and adults are considered separately. A clinical case of a 15-year-old female patient with complaints of persistent rhinitis over the past 4-5 years is discussed. Historical information: a patient had a runny nose over the last 4-5 years: persistent, viscous nasal discharge with moderate nasal congestion. Nasal symptoms worsened with episodes of acute respiratory illness, and nasal discharge became mucopurulent. The child was preliminarily diagnosed with chronic rhinosinusitis (incomplete remission), moderate course. To reduce the severity of the symptoms of the disease, which were present at the time of examination, the following were recommended: daily one-to-two irrigation of the nasal cavity with slightly hypertonic (1.5-3%) solutions of sea water, followed by a toilet of the nasal cavity; in case of episodes of colds with the appearance of mucopurulent secretions, inhalation therapy in a pulsating mode of the inhaler with a solution of thiamphenicol and N-acetylcysteine at a dose of 500 mg once a day (in the first half of the day) for the next 10 days and further; the use of a nasal spray of mometasone furoate, 200 mcg per day during inhalation therapy for another 3 weeks. At the follow-up examination after 10 days of treatment, the patient reported a significant decrease in the severity of nasal symptoms, which coincided with an improvement in the rhinoscopic status. It can be concluded that the use of topical antibacterial drugs by inhalation therapy for acute rhinosinusitis, despite all its advantages, is not an equivalent substitute for systemic antibiotic therapy in the treatment of severe and especially complicated forms of the disease. The inhalation therapy is recommended in the presence of indications for systemic antibiotic therapy, since it is an auxiliary method of treatment, the action of which is aimed at enhancing the effect of systemic antibiotics.
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The aim of this systematic review (SR) was to evaluate the most frequent pollutants and their effect on allergic rhinitis in Latin American countries. Observational studies up to December 2020 and comparing different indoor and outdoor pollutants that had allergic rhinitis (AR) as an outcome were included in the systematic review. Random-effect meta-analyses were conducted for the presence of allergic rhinitis. Estimates were presented as pooled odds ratios (ORs) and their respective 95% confidence intervals (CIs). Twenty-two publications comprised this review according to the inclusion and exclusion criteria and 12 had data that could be analyzed statistically. The most frequent pollutant was PM10, followed by NO2 /O3 and PM2.5 in studies conducted in Argentina, Brazil, Bolivia, Chile, Colombia, Costa Rica, and Peru. The OR of an exposed subject experiencing allergic rhinitis was 1.43 (95% CI 1.026; 1.980). The OR of children and adolescents experiencing of allergic rhinitis was 1.359 (95% CI 1.051; 1.759). Asymmetry and great variability in the effect estimated from the selected studies were observed. The publication bias was quantified by Kendall's correlation and Egger's test resulted in 0.152 (p-value = 0.493). Egger's test provided an intercept equal to 2.511 and a p-value = 0.398. The I2 statistic was 89.3% and reinforces the hypothesis of heterogeneity. This first systematic review conducted in Latin America confirmed the chance of a person exposed to pollutants and experiencing allergic rhinitis is 43% greater than that of a non-exposed person, reinforcing the importance of policies to reduce pollutant exposure and the use of protection systems for workforces exposed to occupational pollutants in work environments.
Article
Introduction: Allergic rhinitis (AR) is a disease which affects >24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. Methods: NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. Results: Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were -7.78 (95% CI: -8.1701 to -7.3967; p < 0.001) and -7.52 (-7.9053 to -7.1320; p < 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. Conclusions: TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.
Article
Background Subcutaneous immunotherapy (SCIT) has been used for treating local allergic rhinitis (LAR) patients. However, the clinical efficacy and safety were still questioned. Objective This study was designed to estimate the efficacy and safety of SCIT for treating LAR patients through meta-analysis. Methods We systemically searched MEDLINE, Cochrane Library, and Embase publications. Randomized, double-blind, clinical trials for the efficacy and safety of Allergen Immunotherapy (AIT) for LAR were included. A meta-analysis of 4 clinical endpoints (combined symptom and medication scores [CSMS], symptom scores [SS], medication scores [MS] and rhinoconjunctivitis quality of life questionnaire [RQLQ]) and adverse events (AEs)) was performed after bias and heterogeneity assessments. The immunologic response results were summarized. Results Four RCTs with 134 patients were included. Four studies for analyzing primary outcomes (CSMS, SS, MS) and AEs, three for RQLQ results. The results indicated an important significant difference between SCIT and placebo groups, list as follows: CSMS (SMD = −2.42, 95% CI: −3.60 to −1.25, P < .0001), SS (SMD = −2.08, 95% CI −3.68 to −0.48, P = .01), MS (SMD = −1.43, 95% CI: −2.65 to −0.21, P = 0.02), RQLQ (SMD = −0.70, 95% CI −1.29 to −0.12, P = .02), Local AEs (RR = 4.13, 95% CI 1.08 to 15.77, P = .04). For immunologic response, significantly increased serum sIgG4 levels and improvements of allergen tolerance was observed after SCIT. Conclusions Our meta-analysis suggests that SCIT has a significant effect on improving symptoms and reducing medicine consumption for LAR patients. Larger and multicenter clinical trials are needed to clarify the safety and long-term efficacy.
Article
Assessment of asthma comorbidities, conditions that adversely affect the pathobiology of asthma or impair its response to therapies, is a fundamental step in the evaluation and management of patients with difficult-to-treat asthma. Identifying and effectively treating asthma comorbidities, such as obesity, obstructive sleep apnea, and chronic sinusitis with nasal polyps may improve asthma control and reduce exacerbations. Additionally, identifying comorbid T2 inflammatory conditions may help guide optimal selection of biologic therapies. Here, we describe common comorbid conditions found in adult and pediatric difficult-to-control asthma, discuss evidence for the association with asthma morbidity and treatment benefit, and provide information on how and when to assess comorbidities.
Chapter
Chronic rhinoconjunctivitis is an increasingly common condition that is now recognized to have a major impact on human health. Persistent nasal dysfunction may have significant effects on physical and emotional functioning, which result in absences from school and work, reduced worker productivity, and impaired school performance. In addition, chronic nasal inflammation may aggravate or lead to the development of other significant disorders, including asthma, rhinosinusitis, and middle ear disease. Recent improvements in our understanding of the pathophysiology of rhinitis are providing key insights into the development of new treatments, including novel immunologic therapies. This chapter presents an overview of the epidemiology, diagnosis, pathophysiology, and treatment of allergic and non-allergic rhinitis.
Article
Objective: Formulating critical clinical questions and outcomes is essential for developing clinical practice guidelines (CPG). This study aims to formulate the key clinical questions and outcomes for the CPG on acupuncture and moxibustion for allergic rhinitis (AR). Method: PICO (patient, intervention, comparator, and outcome) question survey, Delphi survey, and consensus conference of the guideline development group (GDG) were employed. PICO questionnaire were used to gather and analyze the target users’ key demands and interests. The GDG then selected the CPG's critical clinical questions and outcomes via a mixed method of Delphi survey and consensus conference. Results: Fifteen potential clinical questions and ten types of outcomes were formulated based on the analysis of 123 responses from seventeen countries on five continents. After two rounds of the Delphi survey and complete discussions, a consensus was reached by the GDG that all potential questions were included. After three rounds of the Delphi survey and complete debate, the consensus was reached that nine outcomes were considered important. Conclusion: Fifteen key clinical questions and nine important outcomes were formulated for the CPG. These covered issues that elicited the most attention from global users in acupuncture therapy and AR. The results will contribute to the CPG's development and future clinical studies.
Article
Medical treatment options for patients with rhinitis during pregnancy need careful considerations. It is important to distinguish between the causes of rhinitis, as this can influence treatment. Conservative options are important for patients with pregnancy-induced rhinitis (PIR) and pre-existing allergic or non-allergic rhinitis. Education and knowledge that PIR symptoms will resolve after pregnancy can offer some relief. Other strategies such as exercise, positioning, saline nasal douching/lavage, and nasal valve dilators are safe in pregnancy and can have a benefit in these patients with rhinitis of any aetiology. The main medical therapies usually used in rhinitis cannot always be directly translated to pregnant patients due to potential teratogenic effects. Topical corticosteroids have generally shown to be safe with budesonide having the strongest recommendations. Oral corticosteroids are mostly used in moderate-severe disease and should be avoided in the first trimester. Oral decongestants have associations with cardiac, ear, gut and limb abnormalities and are not recommended in the first trimester. Loratadine and cetirizine have been the most well-studied second-generation antihistamines and are generally considered safe. There has been no reported increased risk of teratogenicity with anticholinergics or cromones, with the latter being one of the first line options in pregnant women with allergic rhinitis. The role of allergen immunotherapy needs further research, but current guidance states it can be continued if already initiated prior to pregnancy. The management of rhinitis in pregnancy can therefore be complex. This review aims to evaluate the current medical management options for rhinitis in pregnancy.
Article
Introduction : Intranasal low-level laser therapy (LLLT) has already proven its immunosuppressive effects on allergic rhinitis (AR) in experimental studies; however, there is a dearth of clinical evidence supporting its effects in treating AR. The aim of this study was to assess the safety and effectiveness of intranasal LLLT in the treatment of AR compared with acupuncture. Methods : A total of 80 patients with AR participated and were randomly assigned to the intranasal LLLT or acupuncture treatment (AT) group. They were given each treatment for 20 minutes 3 times a week for 4 weeks. Results : Both groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment. Intranasal LLLT was noninferior to AT in regard to the TNSS. The estimated outcome difference between baseline and the 5th week was −0.38 points (upper 97.5% confidence limit 1.06 points), which was within the noninferiority margin of 2 points. The effect size of the TNSS at the 5th week was 0.19, which was close to Cohen's small effect size. There were no significant differences between two groups regarding the RQLQ, nasal endoscopy index, total serum immunoglobulin E level or absolute eosinophil count. Conclusion : This study showed that intranasal LLLT is noninferior compared to AT in terms of the TNSS; thus, it may be used as an alternative or adjunctive treatment option for relieving symptoms of AR. Trial registration : This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).
Article
Background Various studies have explored potential therapeutic applications of capsaicin in human medicine, for example in pain, obesity, cancer, cardiovascular and respiratory disease. The aim of this scoping review was to identify and chart available evidence on therapeutic applications of capsaicin in humans using any mode of capsaicin delivery to treat conditions of the respiratory system. Methods Electronic bibliographic databases (Web of Science, PubMed, Medline, ScienceDirect, Embase, Scopus) were searched from inception to 2021 to identify experimental studies reporting clinical outcomes of therapeutic applications of capsaicin. Studies with or without control group published in peer-reviewed journals were included. Animal studies, studies of human cell lines, and physiological proof of concept studies were excluded. Reviewer pairs independently double-screened 2799 search results for inclusion. Results Twenty-three original studies were included. Capsaicin has been investigated for the treatment of non-allergic rhinitis (n = 15), nasal polyposis (n = 3), allergic rhinitis (n = 2), unexplained chronic cough (n = 2), and prevention of aspiration pneumonia (n = 1). Modes of delivery included intranasal application (nasal spray, soaked pads, solution), inhalation, ingestion, and aural ointment. Seventeen studies reported positive effects of capsaicin on clinical outcomes for rhinitis, nasal polyposis, chronic cough, and pneumonia. Sixteen studies reported on the safety of capsaicin, with no reports of significant adverse events and overall fair to good patient acceptability. Conclusion While the evidence identified in this review has limited implications for clinical practice, studies support the general safety of capsaicin as administered in these studies and highlight emerging strands of research and clinical hypotheses which warrant further examination.
Article
Allergic rhinitis (AR), the most common chronic allergy in Europe, can markedly undermine quality of life. While there are numerous over-the-counter and prescription drug options, treatment can present challenges. Indeed, many people with AR show poor symptom control despite self-medication. This review focuses on the pharmacology of the main drugs used in primary care to treat AR.
Article
Background: Allergic Rhinitis (AR) is a prevalent chronic inflammatory nasal condition with significant negative effects on the patients' quality of life. This study aimed to investigate the efficacy of Montelukast and intranasal antihistamine in combination with intranasal corticosteroid (INCS) in moderate to severe allergic rhinitis on the patients' quality of life and AR control. Method: This double-blind randomized clinical trial study was carried out on 66 moderate to severe AR patients referred to Namazi Hospital, Shiraz, Iran from 2020 to 2021, who were randomly divided into 3 groups. Group one received Montelukast add-on therapy and Budesonide nasal spray. The second group received intranasal antihistamine (Azelastine) add-on therapy and Budesonide nasal spray and the third group as the control group received intranasal Budesonide spray with a placebo tablet.To measure the impact of each medication on the patient's quality of life and AR control, we employed the Sino-Nasal Outcome Test-22 questionnaire (SNOT 22). We evaluated the symptoms and compared them at baseline, one and three months after the start of treatments. Spirometry was performed to investigate the possibility of co-morbid asthma at baseline and end of the study. Results: The patients' mean age was 30.13 ± 12.7 years. Most patients experienced perennial AR (65.2%). Reduction of mean scores SNOT22 was statistically different between groups (P-value < 0.001). Three months after treatment, the mean decrease of SNOT-22 in the Azelastine group was statistically significant compared to both Montelukast (P-value < 0.001) and control groups (P-value < 0.001). No significant difference was observed between the Montelukast and control groups (P-value = 0.142). 23 of 66 patients were diagnosed with asthma and asthma treatment was initiated. The amount of FEV1 change after AR treatment was not statistically significant between the groups in asthmatic patients (P-value = 0.351). Conclusion: Based on our findings, we recommend Azelastine in conjunction with an intranasal corticosteroid for the treatment of moderate to severe allergic rhinitis. In moderate to severe AR or even asthma management, Montelukast has no greater impact than INCS.
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Background: GSP301 is an investigational fixed-dose combination nasal spray of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). Objective: To evaluate efficacy and safety of GSP301 in patients with seasonal AR (SAR). Methods: In this phase 2, double-blind, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to twice-daily GSP301 (olopatadine 665μg and mometasone 25μg), once-daily GSP301 (olopatadine 665μg and mometasone 50μg), twice-daily or once-daily olopatadine monotherapy (665μg), mometasone monotherapy (twice-daily 25μg or once-daily 50μg), or placebo for 14 days. The primary endpoint-mean change from baseline in morning and evening reflective Total Nasal Symptom Score (rTNSS)-was analyzed using ANCOVA (P<0.05=statistically significant). Average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs) were also assessed. Results: A total of 1,111 patients were randomized. Twice-daily GSP301 provided statistically significant and clinically meaningful rTNSS improvements versus placebo (P<0.001), twice-daily olopatadine (P=0.049) and mometasone (P=0.004). Similar significant improvements in iTNSS were observed with twice-daily GSP301 versus placebo (P<0.001) and twice-daily mometasone (P=0.007); improvements were not significant versus olopatadine (P=0.058). Once-daily GSP301 provided significant rTNSS and iTNSS improvements versus placebo and once-daily olopatadine (P<0.01, all) but improvements were not significant versus mometasone. Treatment-emergent AEs rates were 10.8%, 9.5%, and 8.2%, with twice-daily GSP301, once-daily GSP301, and placebo, respectively. Conclusion: Twice-daily GSP301 treatment was efficacious and well tolerated, providing statistically significant and clinically meaningful improvements in rTNSS (primary endpoint) versus placebo and both monotherapies.
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Background GSP301 nasal spray is a fixed-dose combination of olopatadine hydrochloride (antihistamine) and mometasone furoate (corticosteroid). Objective To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). Methods In this double-blind study, eligible patients (≥12 years of age) with SAR were randomized 1:1:1:1 to twice-daily GSP301 (665 μg of olopatadine and 25 μg of mometasone), olopatadine (665 μg), mometasone (25 μg), or placebo for 14 days. The primary end point—mean change from baseline in average morning and evening 12-hour reflective Total Nasal Symptom Score (rTNSS)—was analyzed via a mixed-effect model repeated measures (P < .05 was considered to be statistically significant). Additional assessments included average morning and evening 12-hour instantaneous TNSS (iTNSS), ocular symptoms, individual symptoms, onset of action, quality of life, and adverse events (AEs). Results A total of 1176 patients were randomized. GSP301 provided statistically significant and clinically meaningful rTNSS improvements vs placebo (least squares mean difference, -1.09; 95% CI, -1.49 to -0.69; P < .001) and vs olopatadine (P = .03) and mometasone (P = .02). Similar significant improvements in iTNSS were also observed with GSP301 (P < .05 for all). Furthermore, GSP301 significantly improved overall ocular symptoms, individual nasal and ocular symptoms, and quality of life vs placebo (P ≤ .001 for all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent timepoints. Treatment-emergent AEs occurred in 15.6%, 12.6%, 9.6%, and 9.5% of patients in the GSP301, olopatadine, mometasone, and placebo groups, respectively. Conclusion GSP301 is efficacious and well tolerated vs placebo for treating SAR-associated nasal and ocular symptoms, with a rapid onset of action of 15 minutes in adult and adolescent patients 12 years and older. Clinical Trial Registration ClinicalTrials.gov: NCT02870205.
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Allergic rhinitis (AR) is a chronic upper respiratory disease estimated to affect between 10 and 40% of the worldwide population. The mechanisms underlying AR are highly complex and involve multiple immune cells, mediators, and cytokines. As such, the development of a single drug to treat allergic inflammation and/or symptoms is confounded by the complexity of the disease pathophysiology. Complete avoidance of allergens that trigger AR symptoms is not possible and without a cure, the available therapeutic options are typically focused on achieving symptomatic relief. Topical therapies offer many advantages over oral therapies, such as delivering greater concentrations of drugs to the receptor sites at the source of the allergic inflammation and the reduced risk of systemic side effects. This review describes the complex pathophysiology of AR and identifies the mechanism(s) of action of topical treatments including antihistamines, steroids, anticholinergics, decongestants and chromones in relation to AR pathophysiology. Following the literature review a discussion on the future therapeutic strategies for AR treatment is provided.
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Background: In China, upper airway cough syndrome (UACS) is only less frequent than cough-variant asthma and accounts for 24.71% of chronic cough. This study aimed to determine the pathogenetic constituents and factors affecting UACS in children of different age groups, and to identify clinical clues for diagnosing UACS and a method for curative effect evaluation. Methods: A total of 103 children with UACS whose chief complaint was chronic cough were studied from January to November 2013 at Children's Hospital, Capital Institute of Pediatrics. According to their age, children with UACS were divided into 3 groups: nursing children, pre-school children, and school-age children. We analyzed the differences in pathogenetic constituents and factors affecting UACS in children. The effect of UACS treatment was evaluated by the visual analog scale (VAS) and an objective examination. Chi-squared test and analysis of variance were performed with the SPSS 19.0 statistical software. Results: There was a high incidence of UACS in school-age children. Rhinitis with adenoid hypertrophy was the main cause of 103 suspected UACS cases. Adenoidal hypertrophy was the major cause of UACS in the pre-school children group, while rhinitis was the major reason in the nursing children and school-age children groups. Among the 103 children, there were 45 allergen-positive children, with no significant difference among different age groups. VAS scores in the different disease groups after treatment were lower than those before treatment (all P < 0.01). VAS scores in different disease groups showed significant differences, except for 12 vs. 24 weeks after treatment (P = 0.023). Different age groups had different secondary complaints. Conclusions: There are different pathogeneses in different UACS age groups. Clinical treatment efficacy of children with UACS can be evaluated by the VAS combined with an objective examination. We recommend that the course of treatment should be 12 weeks.
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Background: GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate intended for seasonal allergic rhinitis (SAR) treatment. Objective: To evaluate the efficacy and safety of once-daily or twice-daily GSP301 in a ragweed pollen environmental exposure chamber. Methods: In this randomized, double-blind, double-dummy study, adults (18-65 years old) with SAR were equally randomized to 665 μg of olopatadine and 25 μg of mometasone (twice-daily GSP301), 665 μg of olopatadine and 50 μg of mometasone (once-daily GSP301), a US Food and Drug Administration-approved formulation of 137 μg of azelastine and 50 μg of fluticasone twice-daily (AzeFlu), a US Food and Drug Administration-approved formulation of 665 μg of olopatadine twice-daily, or placebo (twice-daily). During 2 visits (baseline and end of 14-day treatment), participants assessed SAR symptoms at specified time points. The primary end point-mean change from baseline in instantaneous total nasal symptom score (iTNSS) for twice-daily or once-daily GSP301 vs placebo-was analyzed by analysis of covariance. Onset of action, ocular symptoms, and adverse events were assessed. Results: A total of 180 participants were randomized. Treatment with twice-daily or once-daily GSP301 provided statistically significant improvements in iTNSS vs placebo (twice-daily GSP301: least squares mean difference, -3.60; 95% confidence interval [CI], -4.89 to -2.30; once-daily GSP301: least squares mean difference, -3.05; 95% CI, -4.35 to -1.76; P < .0001 for both). Significant improvements in iTNSS with twice-daily GSP301 occurred by 10 minutes after dosing (-1.26; 95% CI, -2.30 to -0.21; P = .02) and were maintained at all later time points except one (2.5 hours). Treatment-emergent adverse events occurred in 22.2%, 30.6%, 25.0%, 22.2%, and 16.7% of participants in the twice-daily GSP301, once-daily GSP301, AzeFlu, olopatadine, and placebo groups, respectively. Conclusion: In an environmental exposure chamber model, twice-daily and once-daily GSP301 treatments were well tolerated and provided statistically significant and clinically meaningful SAR symptom improvement vs placebo. Trial registration: ClinicalTrials.gov Identifier: NCT03444506.
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Abstract Allergen-specific immunotherapy is a potentially disease-modifying therapy that is effective for the treatment of allergic rhinitis/conjunctivitis, allergic asthma and stinging insect hypersensitivity. However, despite its proven efficacy in these conditions, it is frequently underutilized in Canada. The decision to proceed with allergen-specific immunotherapy should be made on a case-by-case basis, taking into account individual patient factors, such as the degree to which symptoms can be reduced by avoidance measures and pharmacological therapy, the amount and type of medication required to control symptoms, the adverse effects of pharmacological treatment, and patient preferences. Since this form of therapy carries a risk of anaphylactic reactions, it should only be prescribed by physicians who are adequately trained in the treatment of allergic conditions. Furthermore, for subcutaneous therapy, injections must be given under medical supervision in clinics that are equipped to manage anaphylaxis. In this article, the authors review the indications and contraindications, patient selection criteria, and details regarding the administration, safety and efficacy of allergen-specific immunotherapy.
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Background: This document presents the American Thoracic Society clinical practice guidelines for the diagnosis of primary ciliary dyskinesia (PCD). Target audience: Clinicians investigating adult and pediatric patients for possible PCD. Methods: Systematic reviews and, when appropriate, meta-analyses were conducted to summarize all available evidence pertinent to our clinical questions. Evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach for diagnosis and discussed by a multidisciplinary panel with expertise in PCD. Predetermined conflict-of-interest management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists. Three conflicted individuals were also prohibited from writing, editing, or providing feedback on the relevant sections of the manuscript. Results: After considering diagnostic test accuracy, confidence in the estimates for each diagnostic test, relative importance of test results studied, desirable and undesirable direct consequences of each diagnostic test, downstream consequences of each diagnostic test result, patient values and preferences, costs, feasibility, acceptability, and implications for health equity, the panel made recommendations for or against the use of specific diagnostic tests as compared with using the current reference standard (transmission electron microscopy and/or genetic testing) for the diagnosis of PCD. Conclusions: The panel formulated and provided a rationale for the direction as well as for the strength of each recommendation to establish the diagnosis of PCD.
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Purpose Both surgical treatment and non-surgical treatment are suggested by clinicians for children with habitual snoring related to adenotonsillar hypertrophy; However, how should the decision be made remains unclear. The objective of this study was to investigate potential predictors for the treatment decision, i.e., surgical treatment vs wait and see in children with habitual snoring related to adenoidal and/or tonsillar hypertrophy. Methods Children with complaints of snoring and/or apnea associated with adenotonsillar hypertrophy who received polysomnography (PSG) monitoring at our Hospital were recruited. After at least 6 months, the subjects were followed up and grouped according to whether or not they had received adenoidectomy and/or tonsillectomy (AT) execution. The heights, weights, as well as the quality of life (assessed using the obstructive sleep apnea-18 (OSA-18) quality of life questionnaire) and baseline PSG of the subjects were recorded and compared. Two logistic regressions were performed to reveal the factors influencing decision-making on conducting AT. Results A total of 509 children were finally included (345 males and 164 females). Among these children, 287 eventually received AT. Significant differences in age, scores for item 1 and 5 of the OSA-18, apnea–hypopnea index, obstructive apnea index, obstructive apnea–hypopnea index (OAHI), and Lowest arterial oxygen saturation (P < 0.05) were observed between groups. By multivariate logistic regression, the factors that influenced the surgical decision were identified as follows: age < 7 years (P = 0.008: odds ratio [OR] = 1.667, 95% confidence interval [CI] 1.140–2.438), score for item 5 of OSA-18 > 4 points (P = 0.042: OR = 1.489, 95% CI 1.014–2.212) and OAHI > 1/h (P = 0.044: OR = 1.579, 95% CI 1.013–2.463). Conclusion School-age children aged < 7 years, with OAHI > 1/h and mouth breathing scored > 4 points were more likely to receive AT during the disease process and thus require increased attention.
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The World Health Organization (WHO) 2017 classification of head and neck tumors has been just published and has reorganized tumors of the nasal cavity and paranasal sinuses. In this classification, three new entities (seromucinous hamartoma, NUT carcinoma, and biphenotypic sinonasal sarcoma) were included, while the total number of tumors has been reduced by excluding tumors if they did not occur exclusively or predominantly in this region. Among these entities, benign tumors were classified as sinonasal papillomas, respiratory epithelial lesions, salivary gland tumors, benign soft tissue tumors, or other tumors. In contrast, inflammatory diseases often show tumor-like appearances. The imaging features of these benign tumors and tumor-like inflammatory diseases often resemble malignant tumors, and some benign lesions should be given attention in the follow-up period and before surgery to avoid recurrence, malignant transformation, or massive bleeding. Understanding the CT and MR imaging features of various benign mass lesions is clinically important for appropriate therapy. The purpose of this article is to describe the clinical characteristics and imaging features of each of clinically important nasal and paranasal benign mass lesions, as classified according to the WHO 2017 classification of head and neck tumors, along with some inflammatory diseases.
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Nasal allergen challenge (NAC) is an important tool to diagnose allergic rhinitis. In daily clinical routine, experimentally, or when measuring therapeutic success clinically, nasal allergen challenge is fundamental. It is further one of the key diagnostic tools when initiating specific allergen immunotherapy. So far, national recommendations offered guidance on its execution, however, international divergence left many questions unanswered. These differences in the literature caused EAACI to initiate a task force to answer unmet needs and find a consensus in executing nasal allergen challenge.
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Background: Loratadine is a second-generation, non-sedating antihistamine used for the relief of allergic rhinitis symptoms. Previous studies reported that when loratadine was encapsulated, the onset of action for symptom relief was 180 min. However, unmodified loratadine tablets were not evaluated at that time. Using data from a previously published Environmental Exposure Unit (EEU) study comparing azelastine nasal spray with loratadine tablets, cetirizine tablets, and placebo, this post hoc analysis determines the onset of action of loratadine tablets (i.e. unmodified) by analyzing the total symptom score for the relief of nasal and ocular seasonal allergic rhinitis (SAR) symptoms. Methods: A Phase IV, randomized, single-center, double-blind, placebo-controlled, double-dummy, four-way crossover study was conducted in the EEU. Seventy participants were randomized sequentially into one of the four treatments during ragweed pollen exposure. Nasal and ocular symptom scores were self-reported by the participants and recorded. The original study analysis was carried out by evaluating the nasal symptom scores only. For this post hoc analysis, both nasal and ocular data from the loratadine and placebo treatment arms were analyzed. The primary endpoint for this analysis was the onset of action of loratadine as measured by the change in total symptom score (TSS) from baseline in comparison to placebo. The onset of ocular symptom relief using the total ocular symptom score (TOSS) was also reported. Results: Loratadine tablets demonstrated a significant and durable improvement in both TSS (P = .005) and TOSS (P = .013) at 75 min post-treatment administration compared to placebo. The mean proportion of participants reporting none or mild for all component symptoms of TSS and TOSS at 75 min and thereafter was significantly higher in the loratadine (TSS, P = .0005; TOSS, P ≤ .0001) vs. placebo treatment arm. Conclusions: The onset of action of loratadine tablets was 75 min for the relief of nasal and ocular symptoms in adults with SAR. These results suggest a faster onset of action for loratadine tablets (75 min) compared to previously reported studies which were conducted with modified (i.e. gelatin-encapsulated) loratadine tablets (180 min).Trial registration Clinicaltrials.gov identifier NCT00561717.
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Purpose: Chinese herbal medicine (CHM) has been widely used in China to treat allergic rhinitis (AR). However, several studies have produced conflicting data with regard to the efficacy of the medicine. Our aim was to perform a meta-analysis of randomized clinical trials (RCTs) to evaluate the relative efficacy of CHM. Methods: We systematically searched the PubMed, Medline, and Springer electronic databases up to March 2017 for RCTs comparing the efficacy of CHM versus placebo for the treatment of patients with AR. Total nasal symptoms and quality of life were assessed through pooling mean difference (MD) with its 95% confidence interval (CI). Moreover, sensitivity and subgroup analyses according to control design and quality of life assessment were performed to evaluate the source of heterogeneity. Results: Eleven RCTs were enrolled in the meta-analysis. Assessment of overall heterogeneity indicated significant heterogeneity among the individual studies (I²=100%, P<0.00001), and thus ransomed effects model was used to pool data. CHM was found to significantly enhance quality of life compared with placebo (MD=-0.88, (95% CI: -1.55, -0.21); P=0.01). The symptom of itchy nose, sneezing or total nasal symptoms scores were not significantly improved after CHM treatment, although the improvement in itchy nose just failed to reach significance (MD=0.09, (95% CI: 0.00, 0.18); P=0.06). Conclusions: This study suggests that CHM appears to improve the quality of life of AR patients. However, these findings, as well as the findings for the effect of CHM on sneezing, total nasal symptoms, and the symptom of itchy nose, need to be substantiated in larger cohorts of AR patients by further well-designed studies.
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Background Chinese herbal medicine formula Yu ping feng san (YPFS) is commonly used for allergic rhinitis (AR). Previous review had summarized the effectiveness and safety of YPFS, however without any subgroup analysis performed to provide detailed evidence for guiding clinical practice. YPFS was recommended for the management of AR by Chinese medicine clinical practice guideline, but the treatment duration of YPFS was also not specified. The aim of this study is to evaluate the effectiveness and safety of YPFS in treating adult AR with the most recent evidence, and attempt to specify the duration of utilisation through subgroup meta-analyses. Methods Seven databases were searched from their inceptions to September 2017. Randomized controlled trials (RCTs) evaluating YPFS for adult AR were included. Methodological quality of studies was assessed using the Cochrane risk of bias tool. Meta-analysis and subgroup meta-analyses were conducted for evaluating the effectiveness of YPFS. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for rating the quality of evidence. ResultsTwenty-two RCTs involving 23 comparisons were included in this review. YPFS was compared to placebo, pharmacotherapy, and used as an add-on treatment compared to pharmacotherapy. Meta-analyses were feasible for the outcomes of four individual nasal symptom scores and “effective rate”. Four individual nasal symptom scores decreased after YPFS’ combination treatment: itchy nose (MD-0.46, 95% CI[−0.50, −0.42]), sneezing (MD-0.41, 95% CI[−0.47, −0.35]), blocked nose (MD-0.46, 95% CI[−0.54, −0.39]) and runny nose (MD-0.42, 95% CI[−0.58, −0.26]). Based on “effective rate”, meta-analysis showed that YPFS did not achieve better effect than pharmacotherapy (RR1.07, 95%CI [0.94, 1.22), but its combination with pharmacotherapy seemed more effective than pharmacotherapy alone (RR1.27, 95%CI [1.19, 1.34]) (low quality). Subgroup analysis suggested that YPFS was not superior to the second-generation antihistamine (RR1.04, 95%CI [0.90, 1.19]) (low quality). Further, YPFS’ combination treatment seemed more beneficial when it was used for more than three weeks (RR1.15, 95%CI [1.01, 1.32]). In addition, YPFS was well-tolerated for treating adult AR. Conclusion Chinese herbal medicine formula YPFS seems beneficial for adult AR. This potential benefit need to be further evaluated by more rigorous RCTs.
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Objective The removal of nasal foreign bodies (NFBs) can be a difficult task for the inexperienced physician, and the more unsuccessful attempts are made, the more difficult the extraction becomes. We have formulated this simple “four-step” approach to improve success, especially on the first try. Methods A retrospective review of cases requiring NFB removal, seen by one registrar from 2012 to 2016 at Frankston Hospital, was performed. Results From 2012 to 2016, 93 patients were referred, of whom 65 were confirmed to have NFBs. In all, 20 patients were first seen by the registrar and had the NFB removed successfully. Another 28 patients were referred to the registrar only after one failed attempt by another medical personnel, and the remaining 17 patients were referred after two failed attempts. All patients had the NFB removed locally in the emergency department using the “four-step” approach, except four patients who had the NFB removed under general anesthesia in the operating theater. Three of the latter had two failed attempts and had refused further attempts, and the fourth patient had developed epistaxis after a failed removal by his general practitioner. Conclusion When performed correctly, the “four-step” approach will result in the successful removal of NFBs. Ideally, the removal of NFBs should only be performed by an experienced medical personnel, and any failed first attempt removals must be subsequently managed only by an experienced medical personnel.
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Background: Nonallergic vasomotor rhinitis (NAVMR) has been considered a diagnosis by exclusion due to unknown mechanisms or lack of diagnostic biomarkers. Methods: To determine clinical responses and biological pathways in NAVMR subjects challenged to cold dry air (CDA) in an environmental exposure chamber (EEC) pre- and posttreatment with azelastine/fluticasone (AzeFlu), 30 NAVMR subjects, prescreened for CDA-induced symptoms (approx. 14°C, <15% relative humidity, ×1 h) were randomized to treatment with AzeFlu (n = 20) or placebo (n = 10) for 2 weeks. Total nasal symptoms scores, minimum cross-sectional area, cough, and conjunctival redness were recorded at visit 1 (pretreatment) and visit 2 (posttreatment) before, during, and after CDA challenge. At both visits, nasal lavage fluid (NLF) and nasal scrapings (NS) were collected pre- and post-CDA challenge. Substance P, neurokinin-A, and calcitonin gene-related peptide concentrations in NLF were analyzed pre- and postchallenge at each visit. Their relationship with CDA-induced symptoms was determined by statistical analysis. MicroRNA sequencing from NS determined differentially expressed miRNA between the treatment groups post-CDA challenge at each visit. Results: The minimum cross-sectional area (p < 0.05), cough count (p < 0.05), and substance P (p < 0.01) improved posttreatment with AzeFlu versus placebo. Gene targets for differentially expressed miRNAs at visit 1 were enriched for biological pathways regulating epithelial ciliogenesis and cell integrity that were modified in the AzeFlu-treated group versus placebo posttreatment. Conclusions: This study demonstrated the feasibility of an EEC model to investigate CDA-induced clinical responses and pathobiology in NAVMR subjects pre- and posttreatment with AzeFlu. NAVMR disease mechanisms for other nonallergic triggers can be investigated similarly.
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Background: The European Academy of Allergy and Clinical Immunology (EAACI) is developing Guidelines on Allergen Immunotherapy (AIT) for Allergic Rhinoconjunctivitis (ARC). To inform the development of recommendations, we sought to critically assess the systematic review evidence on the effectiveness, safety and cost-effectiveness of AIT for ARC. Methods: We undertook a systematic overview, which involved searching nine international biomedical databases from inception to October 31, 2015. Studies were independently screened by two reviewers against pre-defined eligibility criteria and critically appraised using the Critical Appraisal Skills Programme (CASP) Systematic Review Checklist for systematic reviews. Data were descriptively synthesized. Results: Our searches yielded a total of 5932 potentially eligible studies, from which 17 systematic reviews met our inclusion criteria. Eight of these were judged to be of high, five moderate and three low quality. These reviews suggested that, in carefully selected patients, subcutaneous (SCIT) and sublingual (SLIT) immunotherapy resulted in significant reductions in symptom scores and medication requirements. Serious adverse outcomes were rare for both SCIT and SLIT. Two systematic reviews reported some evidence of potential cost savings associated with use of SCIT and SLIT. Conclusions: We found moderate-to-strong evidence that SCIT and SLIT can, in appropriately selected patients, reduce symptoms and medication requirements in patients with ARC with reassuring safety data. This evidence does however need to be interpreted with caution, particularly given the heterogeneity in the populations, allergens and protocols studied. There is a lack of data on the relative effectiveness, cost-effectiveness and safety of SCIT and SLIT. We are now systematically reviewing all the primary studies, including recent evidence that has not been incorporated into the published systematic reviews.
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Literature is convincing regarding the efficacy of capsaicin nasal treatment in idiopathic rhinitis (IR). However, up to 50% of IR patients do not meet the strict inclusion criteria of the trials conducted so far. As a consequence, the efficacy of capsaicin is unknown in a significant number of IR patients that do not meet the strict inclusion/exclusion criteria (1)(2). 'Mixed rhinitis' (MR) patients have more than one major etiologic factor involved in the mucosal pathology. We have no idea about the efficacy of capsaicin nasal spray in these patients nor about the time interval to seek a second application. We report here that capsaicin nasal spray is effective in a broader group of IR than the purely selected ones described before, that subjective nasal hyperreactivity is a good predictor of positive outcome and that the time interval for seeking a second treatment is likely to be shorter in MR patients than in the strictly selected IR patients. This article is protected by copyright. All rights reserved.
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Introduction Ear, nose and throat (ENT) foreign bodies (FBs) are common occurrences, particularly among children. The proper recognition, study, and management of FBs are required to prevent complications. Their consequences are greatly variable, from mild disturbances that may not require hospitalization up to life-threatening complications. Objective To analyze the clinical spectrum of ENT FBs, the methods of removal, the outcomes and complications as seen in a tertiary referral hospital. Methods This hospital-based cross-sectional retrospective study was performed from July 2014 to June 2016. Patients with any type of ENT FBs, regardless of age, were included in the study; data was collected from 1,013 patients (572 males and 440 females) with a mean age of 12.5 years. Results Foreign bodies represented a large category among ENT emergencies (30%). Children were affected more frequently, particularly ≤ 6 years old. Swallowed FBs were the most common (53.6%), followed by aural FBs (24.68%), nasal FBs (19%), and inhaled FBs (2.6%). A total of 54.69% of ENT s were removed under general anesthesia (GA). Conclusion Foreign bodies (FB) in the ears, nose or throat are a common occurrence in otorhinolaryngology (ENT) emergency services. Children are the most affected age group. The commonest site of FB lodgment is in the throat. Ear, nose and throat FBs need to be properly managed to avoid complications.
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The purpose of our review was to synthesize the existing literature about the prevalence of adenoid hypertrophy in children and adolescents confirmed by the reference standard – the nasoendoscopy. Six electronic databases and grey literature were searched. Studies were included if they reported the prevalence of adenoid hypertrophy confirmed via nasoendoscopy. Studies involving participants with associated comorbidities, fully diagnosed sleep apnea in their sample were excluded. The MAStARI tool assessed the potential risk of bias (RoB) among the studies, while the GRADE approach determined the level of evidence. A total of 5,248 patients were included. Seventeen studies were included in the meta-analysis showing an adenoid hypertrophy prevalence of 49.70% (CI: 39.92 to 59.50). The studies were then divided into 3 groups based on the RoB and patient selection method. The adenoid hypertrophy prevalence for Groups 1, 2 and 3 were 42.18% (CI: 34.93 to 49.60; n=2,794), 70.02% (CI: 40.102 to 92.690; n=538) and 34.46% (CI: 10.507 to 63.742; n=1,446) respectively. High heterogeneity between the studies was found. The GRADE approach classified the quality of evidence as moderate. In a randomized representative population, the prevalence of adenoid hypertrophy was 34.46%; however, in convenience samples the prevalence ranged from 42-70%.
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Background Allergic rhinitis affects 10 to 40% of the population. It reduces quality of life, school and work performance, and is a frequent reason for office visits in general practice. Medical costs are large but avoidable costs associated with lost work productivity are even larger than those incurred by asthma. New evidence has accumulated since the last revision of the Allergic Rhinitis and its Impact on Asthma – ARIA guidelines in 2010 prompting its update. Objective To provide a targeted update of the ARIA guidelines. Methods The ARIA guideline panel identified new clinical questions and selected questions requiring an update. We performed systematic reviews of health effects and the evidence about patient values and preferences, and resource requirements (up to June 2016). We followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) evidence-to-decision frameworks to develop recommendations. Results The 2016 revision of the ARIA guidelines provides updated and new recommendations about the pharmacological treatment of allergic rhinitis. It specifically addresses the relative merits of using oral H1-antihistamines, intranasal H1-antihistamines, intranasal corticosteroids, and leukotriene receptor antagonists either alone or their combination. The ARIA guideline panel provides specific recommendations for the choice of treatment, the rationale for the choice, and discusses specific considerations that clinicians and patients may want to review in order to choose the management most appropriate for an individual patient. Conclusions Appropriate treatment of allergic rhinitis may improve patients’ quality of life, school and work productivity. ARIA recommendations support patients, their caregivers, and health care providers in choosing the optimal treatment.
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The use of antihistamines (AHs) has until recently been associated with a number of undesirable side effects, the most troublesome of which is sedation. There are two aspects to sedation. The first, an objectively determined measure based on the results of psychometric tests from controlled trials, and the second, the subject's response to the administration of a drug. Since AHs are largely used in ambulant patients, a complete evaluation of sedation should be performed through standardised objective and subjective tests, shown to be sensitive to the central effects of AHs. An extensive review of the literature identified 76 studies of H1 receptor antagonists in healthy volunteers, in which assessment of sedation was the primary objective. Results from studies published in peer‐reviewed journals which employed a placebo condition as well as a positive internal control using a crossover design were analysed to determine the extent to which a particular antihistamine produced impairments on a battery of psychometric tests. The impairment index for each antihistamine was calculated and subsequently compared with the impairment index obtained for all other AHs. The calculation of this proportional impairment ratio enabled the sedative potential of an individual antihistamine to be identified relative to all other AHs and thus allowed the ranking of AHs with respect to their ability to cause impairments of cognitive and psychomotor function. Findings from this review clearly demonstrate that there are distinct classes of AHs with respect to their ability to impair cognitive function and psychomotor performance. Copyright © 2000 John Wiley & Sons, Ltd.
Article
Background: Non-allergic rhinitis is defined as dysfunction and non-infectious inflammation of the nasal mucosa that is caused by provoking agents other than allergens or microbes. It is common, with an estimated prevalence of around 10% to 20%. Patients experience symptoms of nasal obstruction, anterior rhinorrhoea/post-nasal drip and sneezing. Several subgroups of non-allergic rhinitis can be distinguished, depending on the trigger responsible for symptoms; these include occupation, cigarette smoke, hormones, medication, food and age. On a cellular molecular level different disease mechanisms can also be identified. People with non-allergic rhinitis often lack an effective treatment as a result of poor understanding and lack of recognition of the underlying disease mechanism. Intranasal corticosteroids are one of the most common types of medication prescribed in patients with rhinitis or rhinosinusitis symptoms, including those with non-allergic rhinitis. However, it is unclear whether intranasal corticosteroids are truly effective in these patients. Objectives: To assess the effects of intranasal corticosteroids in the management of non-allergic rhinitis. Search methods: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 7); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 July 2019. Selection criteria: Randomised controlled trials (RCTs) comparing intranasal corticosteroids, delivered by any means and in any volume, with (a) placebo/no intervention or (b) other active treatments in adults and children (aged ≥ 12 years). Data collection and analysis: We used the standard methodological procedures expected by Cochrane. The primary outcomes were patient-reported disease severity and a significant adverse effect - epistaxis. Secondary outcomes were (disease-specific) health-related quality of life, objective measurements of airflow and other adverse events. We used GRADE to assess the certainty of the evidence for each outcome. Main results: We included 34 studies (4452 participants); however, only 13 studies provided data for our main comparison, intranasal corticosteroids versus placebo. The participants were mainly defined as patients with perennial rhinitis symptoms and negative allergy tests. No distinction between different pheno- and endotypes could be made, although a few studies only included a specific phenotype such as pregnancy rhinitis, vasomotor rhinitis, rhinitis medicamentosa or senile rhinitis. Most studies were conducted in a secondary or tertiary healthcare setting. No studies reported outcomes beyond three months follow-up. Intranasal corticosteroid dosage in the review ranged from 50 µg to 2000 µg daily. Intranasal corticosteroids versus placebo Thirteen studies (2045 participants) provided data for this comparison. These studies used different scoring systems for patient-reported disease severity, so we pooled the data in each analysis using the standardised mean difference (SMD). Intranasal corticosteroid treatment may improve patient-reported disease severity as measured by total nasal symptom score compared with placebo at up to four weeks (SMD -0.74, 95% confidence interval (CI) -1.15 to -0.33; 4 studies; 131 participants; I2 = 22%) (low-certainty evidence). However, between four weeks and three months the evidence is very uncertain (SMD -0.24, 95% CI -0.67 to 0.20; 3 studies; 85 participants; I2 = 0%) (very low-certainty evidence). Intranasal corticosteroid treatment may slightly improve patient-reported disease severity as measured by total nasal symptom score change from baseline when compared with placebo at up to four weeks (SMD -0.15, 95% CI -0.25 to -0.05; 4 studies; 1465 participants; I2 = 35%) (low-certainty evidence). All four studies evaluating the risk of epistaxis showed that there is probably a higher risk in the intranasal corticosteroids group (65 per 1000) compared to placebo (31 per 1000) (risk ratio (RR) 2.10, 95% CI 1.24 to 3.57; 4 studies; 1174 participants; I2 = 0%) (moderate-certainty evidence). The absolute risk difference (RD) was 0.04 with a number needed to treat for an additional harmful outcome (NNTH) of 25 (95% CI 16.7 to 100). Only one study reported numerical data for quality of life. It did report a higher quality of life score in the intranasal corticosteroids group (152.3 versus 145.6; SF-12v2 range 0 to 800); however, this disappeared at longer-term follow-up (148.4 versus 145.6) (low-certainty evidence). Only two studies provided data for the outcome objective measurements of airflow. These data could not be pooled because they used different methods of outcome measurement. Neither found a significant difference between the intranasal corticosteroids and placebo group (rhinomanometry SMD -0.46, 95% CI -1.06 to 0.14; 44 participants; peak expiratory flow rate SMD 0.78, 95% CI -0.47 to 2.03; 11 participants) (very low-certainty evidence). Intranasal corticosteroids probably resulted in little or no difference in the risk of other adverse events compared to placebo (RR 0.99, 95% CI 0.87 to 1.12; 3 studies; 1130 participants; I2 = 0%) (moderate-certainty evidence). Intranasal corticosteroids versus other treatments Only one or a few studies assessed each of the other comparisons (intranasal corticosteroids versus saline irrigation, intranasal antihistamine, capsaicin, cromoglycate sodium, ipratropium bromide, intranasal corticosteroids combined with intranasal antihistamine, intranasal corticosteroids combined with intranasal antihistamine and intranasal corticosteroids with saline compared to saline alone). It is therefore uncertain whether there are differences between intranasal corticosteroids and other active treatments for any of the outcomes reported. Authors' conclusions: Overall, the certainty of the evidence for most outcomes in this review was low or very low. It is unclear whether intranasal corticosteroids reduce patient-reported disease severity in non-allergic rhinitis patients compared with placebo when measured at up to three months. However, intranasal corticosteroids probably have a higher risk of the adverse effect epistaxis. There are very few studies comparing intranasal corticosteroids to other treatment modalities making it difficult to draw conclusions.
Article
Background: Safety and efficacy of GSP301 nasal spray, an investigational fixed-dose combination of olopatadinehydrochloride and mometasone furoate, was established in three large, 2-week seasonal allergic rhinitis studies. Objective: To evaluate long-term (52 weeks) safety and efficacy of GSP301 in patients with perennial allergic rhinitis (PAR). Methods: In this randomized, double-blind, parallel-group study, 601 patients (ages greater than or equal to 12 years) with PAR were randomized 4:1:1 to twice-daily GSP301 (olopatadine 665 mcrograms and mometasone 25 micrograms [pH 3.7]) or two GSP301 vehicle formulations (placebo pH 3.7 or 7.0). Safety (primary end point) was monitored through adverse events (AE), laboratoryassessments, vital signs, and physical examinations at weeks 30 and 52. The change from baseline in the average A.M. reflectiveTotal Nasal Symptom Score (rTNSS) and instantaneous Total Nasal Symptom Score (iTNSS), Physician-assessed Nasal Symptom Scores (PNSS), and quality of life were assessed for GSP301 versus placebo pH 3.7 (p > 0.05 was considered statistically significant). Results: At week 52, treatment-emergent AEs (TEAE) occurred in 51.7, 41.4, and 53.5% of patients in the GSP301, placebo pH 3.7 and placebo 7.0 groups, respectively. No clinically meaningful differences were observed in TEAE incidences or other safety assessments across treatments. At weeks 6 and 30, GSP301 provided significant and clinically meaningful improvementsin average rTNSS and iTNSS versus placebo pH 3.7 (p < 0.01, all comparisons). Similarly, at week 52, GSP301 providedsignificant and clinically meaningful improvements in rTNSS (least-squares mean difference -0.91 [95% confidence interval{CI}, -1.35 to -0.47]; p < 0.001), and iTNSS (least-squares mean difference -0.75 [95% CI, -1.17 to -0.33]; p < 0.001) versus placebo pH 3.7, with significant improvements in each individual symptom (p < 0.05, all comparisons). PNSS and quality of life were significantly improved versus placebo pH 3.7 at weeks 6 and 30 (p < 0.05, all comparisons), but these greater improvements did not reach statistical significance at week 52 (PNSS, p = 0.552; quality of life, p = 0.790). Conclusion: Twice-daily GSP301 was well tolerated and provided statistically significant and clinically meaningfulimprovements in PAR nasal symptoms versus placebo over 52 weeks and demonstrated a favorable safety profile and efficacy.
Article
Taking medical history, physical examination, and performing some in vivo and in vitro tests are necessary for the diagnosis of allergy. Skin prick test (SPT) is considered as the standard method and first-line approach for the detection of allergic sensitization. Although mainly SPT is used for the detection of allergic sensitization, intradermal skin test (IDST) may be necessary, especially in patients with a negative SPT result. IDST is quite safe; however, is nowadays seldom used for detection of inhalant allergy and its value remains controversial. We aimed to investigate whether IDST is useful and necessary in diagnosis of respiratory allergies or not. This study involved 4223 patients with allergic rhinitis (AR) and/or bronchial asthma (BA). SPT results were positive in 2419 patients (57%) and negative in 1804 (43%). IDST was applied to 344 patients with marked allergic symptoms and with negative SPT results. Out of 344 patients, 152 (44%) showed allergic sensitization to IDST. The most commonly encountered allergic response was against the house dust mite (HDM) (32.6%). Allergic response against fungal spores was also relatively high (22%), while the pollen allergy rate (4.3%) was quite low. In BA patients with negative prick test, IDST made a significant contribution to the diagnosis of HDM allergy (p=0.003). To avoid missed diagnosis of AR and BA, particularly regarding the HDM allergy, application of IDST may be beneficial; therefore, IDST should be considered as the next step after SPT for diagnosis of allergy prior to in vitro or provocation tests.
Article
Background: GSP301 is an investigational fixed-dose combination nasal spray that contains the antihistamine, olopatadine hydrochloride (HCl), and the corticosteroid, mometasone furoate. Objective: To evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). Methods: In this double-blind, randomized, parallel-group study, patients (≥12 years of age) with SAR were equally randomized to intranasal GSP301 (olopatadine 665 μg and mometasone 25 μg), olopatadine HCl (665 μg), mometasone furoate (25 μg), or placebo for 14 days of twice-daily treatment. The primary end point was the mean change from baseline in the average A.M. and P.M. 12-hour reflective Total Nasal Symptom Score (rTNSS) analyzed by using mixed-effect model repeated measures (p < 0.05 indicates statistical significance). Additional assessments included instantaneous TNSS (iTNSS), individual nasal symptoms, reflective Total Ocular Symptom Score (rTOSS) and instantaneous Total Ocular Symptom Score (iTOSS), onset of action, Physician-assessed Nasal Symptom Score (PNSS), quality of life, and adverse events (AE). Results: A total of 1180 patients were randomized. Over 14 days of treatment, GSP301 significantly improved average A.M. and P.M. rTNSS versus placebo (least squares mean difference -0.98 [95% confidence interval, -1.38 to -0.57]; p < 0.001) and versus olopatadine (p = 0.003), and approached statistical significance versus mometasone (p = 0.059). GSP301 also significantly improved average A.M. and P.M. iTNSS versus placebo and both monotherapies (p < 0.05, all). Further, GSP301 significantly improved individual nasal symptoms, overall ocular symptoms (rTOSS and iTOSS), and overall quality of life versus placebo (p < 0.01, all). Onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent time points assessed. Results for the PNSS also were significant for GSP301 versus placebo (p < 0.001). The percentages of patients with treatment-emergent AEs treated with GSP301, olopatadine, mometasone, and placebo were 12.9, 12.5, 7.1, and 9.4%, respectively. Conclusion: GSP301 was efficacious and well tolerated for the treatment of SAR symptoms compared with placebo, with a rapid onset of action of 15 minutes in patients ≥12 years of age.Clinical trial NCT02631551, www.clinicaltrials.gov .
Article
Objective The aim of our study was to analyze the montelukast effectiveness in improving oculonasal symptoms, patient‐reported outcomes (PROs), and eosinophilic biomarkers in patients with nonallergic rhinitis eosinophilic syndrome (NARES). Methods We enrolled prospectively 80 symptomatic patients treated with 10 mg once a day of montelukast in monotherapy for 2 months. All patients were investigated before and after treatment. Nasal symptoms (nasal obstruction, rhinorrhoea, sneezing, nasal itching), ocular symptoms (redness/puffiness, watery eyes), and other PROs (olfactory dysfunction, difficulty going to sleep, nighttime awakenings, and nasal congestion on awakening) were scored by visual analogic scale. The following clinical scores were assessed: Total Nasal Symptom Score (T4NSS), Total Ocular Symptom Score (T2OSS), Total Symptom Score of Patient‐Reported Outcomes (TSS‐PROs), and a Composite Symptoms Score (CSS). Patients were classified as responders when a reduction of at least 50% of the CSS was observed. Before and after treatment, the eosinophilic biomarkers in nasal lavage were analyzed: nasal eosinophilia (number of eosinophils per high power field), eotaxin‐1 and eotaxin‐2. Results After treatment, significant reductions were observed for all the symptom scores. Forty‐two of 78 patients were considered responders. A significant reduction of eosinophils in nasal mucosa and of levels of eotaxin‐1 and eotaxin‐2 in nasal lavage were observed after treatment in responder patients. Patients with asthma had an increased probability to be responders. Conclusion NARES patients may benefit from treatment with montelukast. In particular, the presence of concomitant asthma may be predictive of a greater efficacy. Level of Evidence 2. Laryngoscope, 2018
Article
Background Chronic rhinitis (CR) is currently regarded as a syndrome, which presents as several endotypes. The aim of this study was to identify the CR endotype clusters and investigate the inflammatory patterns associated with the different endotypes. Methods A total of 259 CR patients and 20 control subjects were enrolled in this prospective study. Twelve clinical variables were analyzed using cluster analysis and five inflammatory variables were measured to investigate the inflammatory patterns associated with the different clusters. Results Six endotype clusters of CR were defined in the Chinese CR patients. Patients in cluster 1 (38.6%) were diagnosed as allergic rhinitis (AR) without asthma, and in cluster 2 (13.5%) as AR with asthma; with all demonstrating positive results for local eosinophils and high levels of local and serum IgE. Similarly, patients in cluster 3 (18.6%) were diagnosed as nonallergic rhinitis with eosinophilia syndrome (NARES) without asthma and in cluster 5 (5.0%) as NARES with asthma; with all demonstrating positive result for local eosinophils, and negative results for both local and serum IgE. Patients in cluster 4 (4.6%), were diagnosed as local allergic rhinitis (LAR) and showed positive results for local eosinophils and local IgE, but negative results for serum IgE; whereas patients in cluster 6 (19.7%) were diagnosed as idiopathic rhinitis (IR) because of high symptoms scores, but negative findings for local eosinophils, local IgE and serum IgE. Conclusions Chinese CR patients may be clustered into six endotypes with different inflammatory patterns, which may help in delivering individualized treatment. This article is protected by copyright. All rights reserved.
Article
Background Ingestion of button batteries occurs in about ten persons per one million persons each year, with most of them children, and one in every 1000 battery ingestions leads to serious injuries. This study aimed to describe the clinical features and outcome of ingestion or inhalation of button batteries in children spanning a decade from January, 2006 to December, 2016 at a tertiary care hospital. Methods We reviewed the clinical records of children who sought treatment for inhaled or ingested button batteries at our hospital during the study period. Data on gender, age, time from ingestion to treatment, site of impaction, imaging findings, and outcomes were retrieved and analyzed. Results We identified 116 pediatric cases of ingestion or inhalation of button batteries. Their mean age was 26 months. The time from ingestion or inhalation of button batteries to treatment was 0.5 hours to 2 weeks. Ninety-seven (83.6%) button batteries were located in the nasal cavity, 13 (11.2%) in the gastrointestinal (GI) tract including 6 in the esophagus, and 7 in the stomach and lower GI tract, and 6 (5.2%) in the auditory tract. Twenty-one (21.6%) children with nasal button batteries had preoperative septal perforations and one (1.0%) had postoperative septal perforation. One child with esophageal button battery developed esophageal stricture and one died of sudden cardiac arrest perioperatively. One child had auditory damages in the right tympanic membrane and ossicles. Conclusions Inhalation or ingestion may occur in the nasal cavities, the esophagus and GI tract and the auditory tract. Prompt diagnosis and treatment are required for a satisfactory outcome and ingested or inhaled button batteries require different treatment protocols.
Article
Objectives The safety and efficacy of intranasal corticosteroids (INCS) are well established, but there remains apprehension that INCS could lead to systemic side effects, as with oral steroids. The objective of this systematic review was to assess whether the use of INCS lead to increased intraocular pressure (IOP) above 20 mm Hg, glaucoma, or formation of posterior subcapsular cataracts in adult patients with rhinitis. Methods Two medical librarians searched the published literature for records discussing the use of “nasal steroids” in “rhinitis” and their effect on “intraocular pressure,” “cataracts,” or “glaucoma.” Results A total of 484 studies were identified, and 10 randomized controlled trials met our inclusion criteria. Meta‐analysis of 2,226 patients revealed that the relative risk of elevated IOP in those who received INCS was 2.24 (95% confidence interval [CI]: 0.68 to 7.34) compared to placebo. The absolute increased incidence of elevated IOP in patients using INCS compared to placebo was 0.8% (95% CI: 0% to 1.6%). There were zero cases of glaucoma in both placebo and INCS groups at 12 months. The absolute increased incidence of developing a posterior subcapsular cataract was 0.02% (95% CI: −0.3% to 0.4%). Conclusions Use of INCS is not associated with a significant risk of elevating IOP or developing a posterior subcapsular cataract in patients with allergic rhinitis. Presence of glaucoma, however, is the real clinical adverse event of concern. There were zero reported cases of glaucoma at 12 months. Future studies should formally evaluate for glaucoma rather than use IOP measures as a surrogate. Laryngoscope, 2018
Article
Surgical treatments for nasal airway obstruction (NAO) are commonly offered as part of otolaryngology practice. Anatomic causes include septal deviation, inferior turbinate hypertrophy, and nasal valve collapse (NVC). This study was performed to determine the prevalence of anatomic contributors to NAO. A total of 1,906 patients with sinonasal complaints were surveyed by 50 otolaryngologists in varying U.S. geographic regions. Patients were first evaluated using the Nasal Obstruction Symptom Evaluation (NOSE) instrument to assess the NAO symptoms and their severity. Physicians then examined patients for the presence of the three anatomic contributors. Presence of septal deviation and turbinate hypertrophy was assessed through an internal nasal exam with direct or endoscopic visualization based on the physician's standard methodology for diagnosis. Presence of NVC was determined by the modified Cottle maneuver. Among all patients surveyed, prevalence was 67% for NVC, 76% for septal deviation, and 72% for inferior turbinate hypertrophy. We found that 64% of the patients (n = 1,211) had severe/extreme NOSE scores (≥55), representing the most likely nasal obstruction candidates for intervention. In these patients, the prevalence of NVC, septal deviation, and inferior turbinate hypertrophy was 73, 80, and 77%, respectively. Eighty-two percent of the 236 patients with severe/extreme NOSE scores who reported prior septoplasty and/or inferior turbinate reduction had NVC. Our study revealed a comparable prevalence of all three anatomic contributors across all patients and the subset with severe/extreme NOSE scores, highlighting the importance of evaluating the lateral nasal wall as a component of NAO treatment strategy.
Article
Background: Allergic rhinitis is a common condition affecting both adults and children. Patients experience symptoms of nasal obstruction, rhinorrhoea, sneezing and nasal itching, which may affect their quality of life.Nasal irrigation with saline (salty water), also known as nasal douching, washing or lavage, is a procedure that rinses the nasal cavity with isotonic or hypertonic saline solutions. It can be performed with low positive pressure from a spray, pump or squirt bottle, with a nebuliser or with gravity-based pressure in which the person instils saline into one nostril and allows it to drain out of the other. Saline solutions are available over the counter and can be used alone or as an adjunct to other therapies. Objectives: To evaluate the effects of nasal saline irrigation in people with allergic rhinitis. Search methods: The Cochrane ENT Information Specialist searched the ENT Trials Register; CENTRAL; Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 November 2017. Selection criteria: Randomised controlled trials (RCTs) comparing nasal saline irrigation, delivered by any means and with any volume, tonicity and alkalinity, with (a) no nasal saline irrigation or (b) other pharmacological treatments in adults and children with allergic rhinitis. We included studies comparing nasal saline versus no saline, where all participants also received pharmacological treatment (intranasal corticosteroids or oral antihistamines). Data collection and analysis: We used the standard methodological procedures expected by Cochrane. Primary outcomes were patient-reported disease severity and a common adverse effect - epistaxis. Secondary outcomes were disease-specific health-related quality of life (HRQL), individual symptom scores, general HRQL, the adverse effects of local irritation or discomfort, ear symptoms (pain or pressure) and nasal endoscopy scores. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. Main results: We included 14 studies (747 participants). The studies included children (seven studies, 499 participants) and adults (seven studies, 248 participants). No studies reported outcomes beyond three months follow-up. Saline volumes ranged from 'very low' to 'high' volume. Where stated, studies used either hypertonic or isotonic saline solution.Nasal saline versus no saline treatmentAll seven studies (112 adults; 332 children) evaluating this comparison used different scoring systems for patient-reported disease severity, so we pooled the data using the standardised mean difference (SMD). Saline irrigation may improve patient-reported disease severity compared with no saline at up to four weeks (SMD -1.32, 95% confidence interval (CI) -1.84 to -0.81; 407 participants; 6 studies; low quality) and between four weeks and three months (SMD -1.44, 95% CI -2.39 to -0.48; 167 participants; 5 studies; low quality). Although the evidence was low quality the SMD values at both time points are considered large effect sizes. Subgroup analysis showed the improvement in both adults and children. Subgroup analyses for volume and tonicity were inconclusive due to heterogeneity.Two studies reported methods for recording adverse effects and five studies mentioned them. Two studies (240 children) reported no adverse effects (epistaxis or local discomfort) in either group and three only reported no adverse effects in the saline group.One study (48 children) reported disease-specific HRQL using a modified RCQ-36 scale. It was uncertain whether there was a difference between the groups at any of the specified time points (very low quality). No other secondary outcomes were reported.Nasal saline versus no saline with adjuvant use of intranasal steroids or oral antihistamines Three studies (40 adults; 79 children) compared saline with intranasal steroids versus intranasal steroids alone; one study (14 adults) compared saline with oral antihistamines versus oral antihistamines alone. It is uncertain if there is a difference in patient-reported disease severity at up to four weeks (SMD -0.60, 95% CI -1.34 to 0.15; 32 participants; 2 studies; very low quality) or from four weeks to three months (SMD -0.32, 95% CI -0.85 to 0.21; 58 participants; 2 studies; very low quality). Although none of the studies reported methods for recording adverse effects, three mentioned them: one study (40 adults; adjuvant intranasal steroids) reported no adverse effects (epistaxis or local discomfort) in either group; the other two only reported no adverse effects in the saline group.It is uncertain if saline irrigation in addition to pharmacological treatment improved disease-specific HRQL at four weeks to three months, compared with pharmacological treatment alone (SMD -1.26, 95% CI -2.47 to -0.05; 54 participants; 2 studies; very low quality). No other secondary outcomes were reported.Nasal saline versus intranasal steroidsIt is uncertain if there was a difference in patient-reported disease severity between nasal saline and intranasal steroids at up to four weeks (MD 1.06, 95% CI -1.65 to 3.77; 14 participants; 1 study), or between four weeks and three months (SMD 1.26, 95% CI -0.92 to 3.43; 97 participants; 3 studies), or indisease-specific HRQL between four weeks and three months (SMD 0.01, 95% CI -0.73 to 0.75; 83 participants; 2 studies). Only one study reported methods for recording adverse effects although three studies mentioned them. One (21 participants) reported two withdrawals due to adverse effects but did not describe these or state which group. Three studies reported no adverse effects (epistaxis or local discomfort) with saline, although one study reported that 27% of participants experienced local discomfort with steroid use. No other secondary outcomes were reported. Authors' conclusions: Saline irrigation may reduce patient-reported disease severity compared with no saline irrigation at up to three months in both adults and children with allergic rhinitis, with no reported adverse effects. No data were available for any outcomes beyond three months. The overall quality of evidence was low or very low. The included studies were generally small and used a range of different outcome measures to report disease severity scores, with unclear validation. This review did not include direct comparisons of saline types (e.g. different volume, tonicity).Since saline irrigation could provide a cheap, safe and acceptable alternative to intranasal steroids and antihistamines further high-quality, adequately powered research in this area is warranted.
Article
A significant proportion of rhinitis patients without systemic IgE‐sensitization tested by skin prick test and serum allergen‐specific IgE (sIgE) display nasal reactivity upon nasal allergen provocation test (NAPT). This disease phenotype has been termed local allergic rhinitis (LAR). LAR is an underdiagnosed entity affecting children and adults from different parts of the world, with moderate‐to‐severe symptoms, impairment of quality of life and rapid progression to symptom worsening. LAR is a stable phenotype and not merely an initial state of AR. Allergic rhinitis and LAR share many clinical features including a positive NAPT response, markers of type 2 nasal inflammation including sIgE in nasal secretions and a significant rate of asthma development. LAR should be considered as a differential diagnosis in those subjects of any age with symptoms suggestive of AR but no evidence of systemic atopy. Although LAR pathophysiology is partially unknown, in some patients sIgE can be demonstrated directly in the nasal secretions and/or indirectly via positive responses in basophil activation test (BAT). LAR can coexist with other rhinitis phenotypes, especially AR. The diagnosis currently relies on the positivity of NAPT to a single or multiple allergens. NAPT has high sensitivity, specificity and reproducibility, and it is considered the gold standard. BAT and the measurement of nasal sIgE can also contribute to LAR diagnosis. LAR patients benefit from the same therapeutic strategies than AR individuals, including the avoidance of allergen exposure and the pharmacotherapy. Moreover, several recent studies support the effectiveness and safety of allergen immunotherapy for LAR, which opens a window of treatment opportunity in these patients. This article is protected by copyright. All rights reserved.
Article
Purpose of review: To examine the recent advances on epidemiological studies, diagnostic approach and clinical management of local allergic rhinitis (LAR) in adults and children. Recent findings: Evidence about LAR is growing especially in pediatric and Asian populations. The prevalence of LAR is lower in Asian countries compared with western countries in both children and adults. LAR is considered a chronic condition and an independent rhinitis phenotype that affects up to 26.5% of nonatopic rhinitis patients. The disease rapidly progress toward the clinical worsening with associated onset of asthma and conjunctivitis, which further impairs patient's quality of life. Nasal Allergen Provocation Test is the diagnostic gold standard that can be complemented by basophil activation test and the detection of specific IgE in nasal secretions. Allergen immunotherapy induces a significant and early improvement in both clinical symptoms and quality of life in LAR patients. Summary: LAR is a common entity, with different prevalence depending on geographical locations. LAR has to be considered in the process of differential diagnosis in children and adults with rhinitis. Diagnosis of LAR is crucial in order to start an etiologic treatment such as allergen immunotherapy, which has proven to be very effective in these patients.
Article
Managing symptoms of allergic rhinitis (AR) and urticaria in pregnant women is important to reduce complications and negative outcomes. The objective of this study was to provide information on the pregnancy outcomes of women exposed to the antihistamine cetirizine (CTZ). The UCB Pharma Patient Safety Database was searched for pregnancies up to 28 February 2015. Maternal CTZ exposure reports were extracted, and pregnancy outcomes were examined, including exposure, comorbidities and infant events. 228 of 522 pregnancies with maternal CTZ exposure had available outcomes; 49 were prospective. The majority (83.7%) resulted in live births; four spontaneous miscarriages, three induced abortions and one stillbirth were reported. Most pregnancies were exposed during the first trimester. Two congenital malformations were reported. The results suggest that CTZ exposure is not associated with adverse pregnancy outcomes above the background rates. While reassuring, the strengths and limitations of a safety database study need to be considered. • Impact statement • What is already known on this subject? AR and urticaria can substantially affect pregnant women, and adequately managing their symptoms is important to reduce maternal and foetal complications. Antihistamines are efficacious, however, there is still a lack of data regarding use during pregnancy. Although current evidence indicates that antihistamines are well-tolerated during pregnancy, data regarding foetal safety are inconclusive. • What do the results of this study add? Our study suggests that CTZ exposure during pregnancy is not linked to an increase in adverse outcomes. CTZ exposure mainly happened during the first trimester only, when most organogenesis takes place. Most of the maternally exposed, prospective pregnancies resulted in live births (83.7%). Congenital malformations occurred in 2/41 live births from the CTZ-exposed pregnancies. • What are the implications of these findings for clinical practice and/or further research? Our study presents a detailed data analysis from a large number of CTZ-exposed pregnancies, and its results are in line with those from previous reports. While the limitations of a safety database study need to be considered, the results shown here are reassuring. Further prospectively reported pregnancies are required, before definite conclusions on the risks of CTZ exposure during pregnancy can be drawn.
Article
Nasal and ocular challenges facilitate the evaluation of subjective and objective responses to defined allergen or irritant exposure. Nasal and ocular allergen challenges (NACs and OACs) are the gold standard to diagnose allergic rhinitis and conjunctivitis, respectively, and aid in the evaluation of novel therapies in clinical trials. Additionally, NACs and OACs may help identify medically relevant allergens in clinical practice. Nonspecific or irritant challenges evaluate mucosal hyperreactivity. Direct mucosal challenges, which can be performed in an office or research setting, expose the participant to higher allergen doses than common in the natural environment. Park studies and environmental chambers, most practical in clinical trials, more closely simulate natural allergen exposure. International consensus guidelines for nasal and ocular challenges do not exist. Therefore, the positivity criteria, methodologies, and extract or allergen preparations utilized in challenges vary in the literature. Regardless of these limitations, nasal and ocular challenges are helpful clinical and research tools for nasal and ocular diseases.
Article
Background: A fixed-dose combination of intranasal azelastine hydrochloride-fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis (AR), but its onset of action requires further investigation. Objectives: This study compared onset of action of MP-AzeFlu with the free combination of oral loratadine and intranasal fluticasone propionate (LORA/INFP). Methods: In this single-center randomized, placebo-controlled, double-blind, double-dummy, three-period crossover trial, AR symptoms were induced in asymptomatic patients by ragweed pollen challenge in an allergen environmental exposure chamber. Patients received single-dose MP-AzeFlu, LORA/INFP, or placebo and were monitored for 4 hours. The primary outcome was onset of action measured by total nasal symptom score (TNSS). Secondary measures were total ocular symptom score (TOSS), total score of the seven nasal and ocular symptoms (T7SS), and the global visual analogue scale (VAS). Results: The full analysis set included 82 patients; 78 completed all treatments. TNSS was significantly reduced versus placebo from 5 minutes for MP-AzeFlu and 150 minutes for LORA/INFP onward (both P<0.05) until the end of assessment (0 to 4 hours). MP-AzeFlu reduced TNSS to a greater extent at each time point from 5 to 90 minutes (P<0.05) and over the entire assessment interval (P≤0.005) versus LORA/INFP or placebo. No statistically significant difference between LORA/INFP and placebo was observed over the assessment interval (P=0.182). MP-AzeFlu onset of action assessed by TOSS, T7SS, and VAS was 10 minutes, 2 h