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COMPARATIVE STUDY ON THE EFFICACY OF MOMETASONE AND FLUTICASONE NASAL SPRAYS FOR TREATMENT OF ALLERGIC RHINITIS

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Objective: Allergic rhinitis is the most prevalent of allergic diseases in the world. Nasal corticosteroids are the most applicable drugs for the treatment of allergic rhinitis. In this study, we compared the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.Methods: For this study, 75 allergic rhinitis patients based on skin prick test and inclusion criteria were randomly assigned to two groups: FP and MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 mg dose of MF nasal spray (1 spray/nostril) daily for 8 w. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 w after the beginning of the treatment.Results: Results showed that patients in both groups exhibited significant improvement in their TNSS (P Value<0.001). A detailed TNSS analysis showed MF to be more effective for relieving all symptoms than FP. The most difference is in decreasing postnasal discharge (PND) symptom. However, the difference for relieving all symptoms is not significant (P value>0.05).Conclusion: In conclusion, FP and MF are significantly effective in relieving of allergic rhinitis symptoms. Even though, the difference between the two is not significant for 8 w therapy.
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Original Article
COMPARATIVE STUDY ON THE EFFICACY OF MOMETASONE AND FLUTICASONE
NASAL SPRAYS FOR TREATMENT OF ALLERGIC RHINITIS
MAHSHID SADAT MIRMOEZZI
1
, MOHAMMAD SHURIDEH YAZDI
2
, OMID GHOLAMI
3*
1
Medical Student at the Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran,
2
Department of Otolaryngology-Head
and Neck Surgery, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran,
3
Department of Physiology and
Pharmacology, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran
Email: omidghphd@gmail.com
Received: 31 Oct 2016 Revised and Accepted: 30 Jan 2017
ABSTRACT
Objective: Allergic rhinitis is the most prevalent of allergic diseases in the world. Nasal corticosteroids are the most applicable drugs for the
treatment of allergic rhinitis. In this study, we compared the efficacy of fluticasone propionate (FP) and mometasone furoate (MF) nasal sprays in
the treatment of allergic rhinitis based on total nasal symptom score (TNSS) questionnaire.
Methods: For this study, 75 allergic rhinitis patients based on skin prick test and inclusion criteria were randomly assigned to two groups: FP and
MF groups. FP group received 200 µg dose of FP nasal spray (1 spray/nostril) daily and the MF group received 100 mg dose of MF nasal spray (1
spray/nostril) daily for 8 w. The effects of the two agents were compared based on TNSS questionnaire in 0, 4 and 8 w after the beginning of the
treatment.
Results: Results showed that patients in both groups exhibited significant improvement in their TNSS (P Value<0.001). A detailed TNSS analysis
showed MF to be more effective for relieving all symptoms than FP. The most difference is in decreasing postnasal discharge (PND) symptom.
However, the difference for relieving all symptoms is not significant (P value>0.05).
Conclusion: In conclusion, FP and MF are significantly effective in relieving of allergic rhinitis symptoms. Even though, the difference between the
two is not significant for 8 w therapy.
Keywords: Fluticasone Propionate, Mometaseone Furoate, Allergic Rhinitis, Total Nasal Symptom Score (TNSS) questionnaire
© 2016 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
DOI: http://dx.doi.org/10.22159/ijpps.2 017v9i3.15958
INTRODUCTION
Allergic rhinitis represents a global health problem that affects 10 to
20% of the population [1]. Allergic rhinitis is a type I hyper-
sensitivity reaction to exogenous substances like a plant or animal
allergens. In this type of reaction, the cutaneous, mucosal-cutaneous
or anaphylactic reaction occurs immediately or several minutes
after exposure. Diagnostic criteria of allergic rhinitis are recurrent
chronic nasal symptoms such as congestion, rhinorrhea (often
including postnasal drip), nasal itching, sneezing, and conjunctiva
irritation [2]. Allergic rhinitis causes sleep disturbance, impairs
psychosocial functioning, and reduces life quality [3].
Allergic rhinitis treatment includes allergen avoidance, pharma-
cotherapy, and immunotherapy. Intranasal corticosteroids are
recommended as first-line therapy for patients with moderate-to-
severe Allergic Rhinitis, especially when nasal congestion is a major
component of symptoms [4]. To compare the efficacy and safety
profile of different available Intranasal corticosteroids for the
treatment of Allergic Rhinitis, it is important to understand the
difference in chemical structures, their pharmacokinetic and
pharmacodynamics properties [4].
Chemical structure of fluticasone and mometasone are displayed in
fig. 1. Relative receptor affinity of MF is greater than FP (2244 vs.
1775) [4]. As pharmacokinetic properties, the bioavailability of MF
is more than FP (46% vs. 42%), and Fraction of unbound intranasal
FP in plasma is more than MF (0.1 vs. 0.01) [5]. Based on these
pharmacodynamics/pharmacokinetic properties, we respect to have
a better clinical outcome for MF than FP.
Fig. 1: Structure of mometasone (A) vs. fluticasone (B) [6]
Despite numerous articles about the efficacy of FP and MF nasal
spray exist, there is no research about the comparing of the
efficacy of these two drugs.
Based on these data, comparing the efficacy of FP and MF on
allergic rhinitis symptoms based on TNSS questionnaire is the aim
of this manuscript.
International Journal of Pharmacy and Pharmaceutical Sciences
ISSN- 0975-1491 Vol 9, Issue 3, 2017
Gholami et al.
Int J Pharm Pharm Sci, Vol 9, Issue 3, 211-214
212
MATERIALS AND METHODS
Participants
This study was conducted in the Division of Otolaryngology, Head
and Neck Surgery at Vasei Medical University Hospital, Sabzevar,
Iran, between August 2015 and March 2016. The study was
approved by the vice chancellor for research of Sabzevar University
of Medical Sciences and Iranian Registry for Clinical Trials
(IRCT2016031419240N2), and written consent was obtained prior
to commencement. The study did not receive the MF and FP
Corporate Support Grant.
The inclusion criteria were: 1) persistent of Allergic Rhinitis
(defined based on clinical examination and verified questionnaire)
2) a positive reaction confirmed by a skin-prick test response. In
positive skin-prick test responses, the skin becomes red and swollen
with a wheal>3 mm in diameter.
The exclusion criteria were: 1) infection in the 2 w preceding the
initial visit; 2) upper and lower respiratory tract infection within 2 w
prior to the study; 3) medication consumption that may affect
allergy symptoms (such as oral antihistamines, decongestants,
steroids, or leukotriene antagonists) within 2 w prior to the study or
during the study period; 4) intranasal corticosteroid use within 2 w
prior to the study; and 5) nasal polyp disease.
In total, 75 patients with allergic rhinitis met the inclusion criteria
for this study.
Study design
In the initial screening visit, comprehensive medical and allergy
histories were obtained for all participants. Daily-activity diaries
were provided to the participants, with instructions to record all
symptoms once treatment began. The diaries of patient activity for
the preceding 7 d were also reviewed.
The study design was randomised, prospective, single-blind and
controlled. The participants were randomly divided into two groups
each participant received a unique code. Of the 75 participants, 6
cases were excluded during the study (2 cases from FP group and 4
cases from MF group), 36 cases received FP nasal spray (FP group),
and 33 cases received MF nasal spray (MF group). FP group received
a 200 µg dose of FP nasal spray (1 spray/nostril) daily for 8 w, and
the remaining participants (MF group) received a 100 µg dose of MF
nasal spray (1 spray/nostril) daily for 8 w.
Total nasal symptom score (TNSS)
Rhinitis symptoms were measured using a 4-point scale. Scores as
follows: 0 denoted “none” (no noticeable symptoms); 1 denoted
“mild” (symptoms are noticeable but not bothersome); 2 denoted
“moderate” (symptoms are noticeable and occasionally bothersome
but do not disturb daily activities and sleep); and 3 denoted “severe”
(symptoms are generally bothersome and disturb daily activities
and sleep). The examiner recorded the patient scores for six nasal
symptoms (nasal congestion, rhinorrhea, postnasal drip (PND),
nasal itching, smelling disorder and sneezing). Baseline TNSS and
each symptom score were calculated as the mean of the scores after
0, 4 and 8 w of initiation of treatment [7].
Statistics
Statistical analysis was performed using IBM SPSS statistics
software. All data are expressed as mean±standard deviation. An
independent sample t-test was used to compare the improvement
rates of the mean TNSS for the two groups. A p value<0.05 was
considered statistically significant. A paired t-test was used to
compare the improvement rates of the mean TNSS for each group
from w0 to w4 and w8. A p value<0.001 was considered statistically
significant.
RESULTS
A total of 75 patients were enrolled in this study, with 36 patients
assigned to an FP group and 33 patients assigned to an MF group.
However, 6 patients with incomplete TNSS recordings during the
treatment period were subsequently excluded from this study. The
mean age of the patients was 21.46 (9.624) years (for FP group) and
20.136 (9.198) years (for MF group). No significant differences were
observed between the two groups for baseline demographics or
health characteristics (table 1).
Table 1: Demography of characteristics and baseline data of the both fluticasone propionate (FP) and mometasone furoate (MF) groups
Variables
FP group
MF group
Number
36
33
Gender
Male
16 (48.5
%)
Female
Age (y)
21.46 (9.624)
20.136 (9.198)
Data are presented as n (%) or mean (standard deviation)
Fig. 2: Mean value of total nasal symptom score (TNSS) in W0,
W4 and W8 (**p<0.001)
For both the FP and MF groups, we analyzed the change in TNSS
from baseline (W 0) to Ws 4 and 8 of the treatment. The TNSS was
the sum of the six nasal symptom scores. No statistically significant
differences were observed between the two groups for baseline
(W0) TNSS scores (Baseline TNSS scores for FP group is 11.46 and
for MF group is 12.18).
The FP and MF groups experienced improvement in allergic rhinitis
nasal symptoms, with symptom improvements of nasal congestion,
rhinorrhea, PND, nasal itching, smelling disorder and sneezing
achieving statistical significance (p value<0.001) from w0 to w4 and
from w0 to w8. Improvement in nasal symptoms for MF group was
better than FP group, but this difference was not significant (p
value<0.05) (fig. 2 and table 2).
DISCUSSION
We found MF sprays to be more effective than FP sprays for
relieving nasal symptoms, as evidenced by the differences in TNSS
between the two groups. But this difference was not significant (p-
value ≤0.05). Some studies found that FP and MF are effective and
safe in allergic rhinitis [8-17]. Some of their results are consistent
with our results, and some of them are not.
Mandl et al. indicated that Mometasone furoate and fluticasone
propionate adequately controlled symptoms of perennial rhinitis
Gholami et al.
Int J Pharm Pharm Sci, Vol 9, Issue 3, 211-214
213
and were well tolerated [8]. Their results are in harmony with our
results. In a recent study, Yonezaki et al. found that fluticasone furoate
was significantly preferred over mometasone furoate in allergic
rhinitis [16]. Their results are not consistent with our results.
In another study, researchers found that following the 4-w therapy,
mometasone furoate (MF) nasal spray provided greater improvement
compared to fluticasone propionate (FP) nasal spray for symptoms
of childhood perennial allergic rhinitis.
Based on their Total Symptom Scores (TS Ss) questionnaire, the
MF group experienced more effecti ve relief of nasal symptoms,
where as the FP group experienced more effective relief of non-
nasal sym ptoms [2].
Table 2: Changes in total nasal symptom score from baseline (W 0) of individual symptoms
Fluticasone propionate group
Mometasone furoate group
Nasal Symptoms
Nasal
congestion
W0
-
W4
-
1.385 (0.815)
-
1.821 (0.548)
W0
-
W8
-
1.821 (0.79)
-
2.321 (0.67)
W4
-
W8
-
0.436 (0.502)
-
0.5 (0.509)
Rhinorrhea
W0
-
W4
-
1.513 (0.854)
-
1.679 (0.67)
W0
-
W8
-
1.795 (0.695)
-
1.964 (0.508)
W4
-
W8
-
0.282 (0.456)
-
0.286 (0.46)
PND
W0
-
W4
-
0.897 (0.598)
-
1.286 (0.6)
W0
-
W8
-
1.051 (0.605)
-
1.357 (0.559)
W4
-
W8
-
0.154 (0.366)
-
0.071 (0.262)
Nasal
itching
W0
-
W4
-
1.487 (0.823)
-
1.714 (0.713)
W0
-
W8
-
1.59 (0.818)
-
1.893 (0.786)
W4
-
W8
-
0.103 (0.307)
-
0.179 (0.39)
Smelling
disorder
W0
-
W4
-
1
.128 (0.656)
-
1.357 (0.731)
W0
-
W8
-
1.538 (0.822)
-
1.643 (0.911)
W4
-
W8
-
0.41 (0.549)
-
0.286 (0.46)
Sneezing
W0
-
W4
-
1.41 (0.85)
-
1.393 (0.685)
W0
-
W8
-
1.538 (0.822)
-
1.464 (0.744)
W4
-
W8
-
0.128 (0.339)
-
0.071 (0.262)
Data are presented as means±standard deviation
This study was subject to several limitations. First, recall bias
contributed to the inconsistent TNSS results. It is better to employ
various examinations, such as nasal peak expiratory flow rate
(nPEFR) and the eosinophil percentage in nasal smears, to reduce
questionnaire bias. Second, we did not classify the severity of
patients’ allergic rhinitis in this study; otherwise, the possible
response differences to treatment for mild persistent, severe-
intermittent, or severe persistent types of allergic rhinitis could have
been analyzed. At last, we lacked patient data on family member
smoking habits and household pets, which are factors that may
affect allergic rhinitis symptoms [9].
CONCLUSION
Our study results show that both intranasal corticosteroid sprays
(FP and MF) were effective for managing allergic rhinitis. FP and
MF treatment were associated with a significant improvement in
mean TNSS (P value<0.001). A further detailed analysis of TNSS
indicated that MF was more effective than FP for relieving nasal
symptoms (except sneezing, table 2), but this difference was not
significant.
In conclusion, the results of our 8-w treatment program showed
that FP and MF nasal sprays were effective for improving the
symptoms of allergic rhinitis significantly. Although the TNSS for
the FP and MF group did not show a significant difference between
them.
ACKNOWLEDGMENT
This study is part of Mahshid Sadat Mirmoezzi M. D. thesis titled:
“Comparison of Mometasone Furoate and Fluticasone Propionate Nasal
Sprays in the Treatment of Allergic Rhinitis”, which has been conducted
in the faculty of medicine, Sabzevar University of Medical Sciences.
This Research Project was fully sponsored by Vice Chancellor for
Research of Sabzevar University of Medical Sciences with grant
number “393010173”. The study did not receive the MF and FP
Corporate Support Grant.
The funding organization is a public institution and had no role in
the design and conduct of the study; collection, management, and
analysis of the data; or preparation, review, and approval of the
manuscript.
CONFLICTS OF INTERESTS
We certify that no actual or potential conflict of interest in relation
to this article exists.
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How to cite this article
Mahshid Sadat Mirmoezzi, Mohammad Shurideh Yazdi, Omid
Gholami. Comparative study on the efficacy of mometasone and
fluticasone
nasal sprays for treatment of allergic rhinitis. Int J Pharm
Pharm Sci 2017;9(3):211-214.
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To report a severe adverse drug reaction (ADR) due to administration of injection hydrocortisone sodium succinate and to explore the possibility of an association between injection hydrocortisone and the severe ADR. After getting ethics approval from the institution, ADR form and patient’s clinical record from the Department of Cardiology, in a Private Medical College was received. In that, it was recorded as a 75-year-old male patient, a case of unstable angina with troponin T - positive, was posted for coronary angiogram developed a severe reaction to intravenous (IV) hydrocortisone 100 mg stat, given to prevent allergy to contrast dye used in the procedure. 5 minutes after drug administration, he developed sudden itching all over the body, hypotension blood pressure: 60 mmHg and swelling of lips. No other drugs had been given at that time. The patient was already on aspirin 150 mg, clopidogrel 75 mg, and atorvastatin 80 mg, and enoxaparin 40 mg. The procedure was abandoned, and the patient was given injection pheniramine maleate 45.5 mg IV, injection dopamine 10 mcg/kg/min IV. He symptomatically improved within 6 hrs. Causality analysis using the WHO scale categorizes it as probable, as anaphylaxis occurred immediately after administration of hydrocortisone, no other drugs were given at that time, and rechallenge was not done. Very few cases of various steroid-induced anaphylaxis have been reported worldwide. This one among the rare ADR report may be due to the steroid or the excipients in the preparation. Skin prick test or in vitro (radioallergosorbent test assay) test can be done immediately to confirm the causative allergen in this case and would also help in identifying specific agents that will be tolerated in the future treatment.
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Allergic rhinitis (AR) is a prevalent disease with great morbidity and significant societal and economic burden. Intranasal corticosteroids are recommended as first-line therapy for patients with moderate-to-severe disease, especially when nasal congestion is a major component of symptoms. To compare the efficacy and safety profile of different available intranasal corticosteroids for the treatment of AR, it is important to understand their different structures and pharmacokinetic and pharmacodynamic properties. Knowledge of these drugs has increased tremendously over the last decade. Studies have elucidated mechanisms of action, pharmacologic properties, and the clinical impact of these drugs in allergic respiratory diseases. Although the existing intranasal corticosteroids are already highly efficient, the introduction of further improved formulations with a better efficacy/safety profile is always desired. Fluticasone furoate nasal spray is a new topical corticosteroid, with enhanced-affinity and a unique side-actuated delivery device. As it has high topical potency and low potential for systemic effects, it is a good candidate for rhinitis treatment.
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Objectives: The present study was under taken to assess and compare the improvement in HRQoL among mild to moderate persistent asthma between Mometasone & Formoterol versus Fluticasone & Formoterol using dry powder inhaler using Asthma HRQoL questionnaire which is disease-specific 32-item instrument including 4 domains: symptoms, emotions, exposure to environmental stimuli and activity limitations where impairments experienced during the previous 14 days and respond on 7-point scale. Methods: The present study was conducted in Preventive Medicine Unit and Chest & TB diseases OPD, KIMS & RC, Bangalore during March 2011 to February 2012. 60 patients were recruited in each group based on inclusion and exclusion criteria. PFT was done pre and post bronchodilator with Salbutamol nebulization with Spirometry. Study medications were randomized and were given for 12weeks. HRQoL questionnaire was administered before and after the medications and outcome was compared between them. Statistical test used were descriptive statistics, t-test. Results: There was a significant improvement in HRQoL from baseline to the end of 12 weeks in all domains (symptoms, emotional, exposure to environmental stimuli and activity limitations) in both the groups. The overall improvement in the HRQoL was better in Mometasone & Formoterol group compared to Fluticasone & Formoterol group but this difference was not statistically significant, which revealed both combinations were equally effective in improving HRQoL in mild to moderate persistent asthma. Conclusion: Both Mometasone & Formoterol and Fluticasone & Formoterol combinations are equally effective in improving HRQoL in mild to moderate persistent asthma patients.
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Background: Fluticasone furoate nasal spray (FFNS) is a glucocorticoid developed for the treatment of allergic rhinitis (AR). This is the first randomized clinical trial to assess the efficacy and safety of FFNS in Japanese children with perennial AR (PAR). Methods: In this multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study, 261 children aged 6 to <15 years were treated with FFNS 55μg, once daily or placebo for two weeks. Nasal and ocular symptoms were rated by parents/guardians/patients in the patient daily diary. The primary endpoint was the mean change from baseline in the three total nasal symptom score (3TNSS). In addition, rhinoscopic findings were rated by the investigators as an efficacy measure. As a safety measure, adverse events and clinical chemistry and hematology were evaluated. Results: Mean change from baseline over the entire treatment period in 3TNSS was greater in the FFNS 55μg group compared with placebo, and the difference was statistically significant (p < 0.001). Significant improvements in rhinoscopic findings of swelling of inferior turbinate mucosa and quantity of nasal discharge were also observed. The total ocular symptom score (TOSS) was reduced significantly in the FFNS 55μg group, compared with placebo, in the second week in a subgroup of patients with baseline TOSS > 0. The incidence of adverse events was similar between FFNS 55μg(18%) and placebo (19%). Conclusions: Two-week treatment with FFNS 55μg, once daily is effective and tolerable in Japanese children aged 6 to <15 years with PAR.
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Background: Various studies have investigated the efficacies of mometasone furoate monohydrate (MFM) and fluticasone propionate (FP) nasal sprays for adults. However, research on their effectiveness for children is limited. This study compares the efficacies of MFM and FP nasal sprays in pediatric patients with perennial-allergic rhinitis. Materials and methods: For this study, 94 perennial allergic rhinitis patients aged 6-12 years were randomly assigned to two treatment groups: an MFM group and an FP group. Treatment was provided for 4 weeks. The effects of the two agents were compared using the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire and total symptom scores (TSSs). Nasal-peak expiratory flow rates and eosinophil percentage in nasal smears were also compared between the two groups. Results: Patients in the MFM group exhibited significant improvement in their TSS (t = -2.65, p < 0.05). A detailed TSS analysis showed MFM to be more effective for relieving nasal symptoms, whereas FP was more effective for relieving non-nasal symptoms. Patient questionnaire scores suggested a significant reduction in symptoms for both the MFM (t = -7.23, p < 0.01) and FP (t = -5.43, p < 0.01) groups. The flow rate test results indicated significant improvements in the MFM group (t = 2.27, p < 0.05). Conclusion: Following the 4-week therapy, MFM provided greater improvement compared to FP for symptoms of childhood perennial-allergic rhinitis. Based on their TSSs, the MFM group experienced more effective relief of nasal symptoms, whereas the FP group experienced more effective relief of non-nasal symptoms.
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Oral allergy syndrome (OAS) is a unique allergic reaction to food, which is caused by cross-reactivity between proteins in fresh fruits or vegetables and pollens. Predisposing factors for OAS are not well known in patients with seasonal allergic rhinitis. Identify the probable risk factors for OAS in patients with seasonal allergic rhinitis. One hundred and eleven consecutive patients with seasonal allergic rhinitis were included. Patients were evaluated in terms of symptom scores and skin prick test positivity scores. Prick-by-prick tests with the fresh fruit or vegetable were carried out in patients who describe oral allergy syndrome. Patients with OAS and without OAS were compared statistically. OAS was more frequent in females than males (p=0.01). Odds ratio for gender (male/female) was 3.80 (95% confidence interval: 1.28-11.32). Within nasal symptoms, only nasal itching was related with OAS (P<0.05). The logistic regression analysis revealed a significant association between the prevalence of the OAS and age, asthma, TSS and TSTP (p<0.05). Not all patients with seasonal allergic rhinitis develop OAS. It is likely that, patients with OAS have some additional risk factors other than atopy.
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Objective: Intranasal corticosteroid sprays (INCSs) are commonly used for therapy of allergic rhinitis (AR). Adherence to regular use of INCSs is influenced by patient perception and preferences of products. The study objective was to compare perceived sensory attributes of fluticasone furoate nasal spray (FFNS) and mometasone furoate nasal spray (MFNS) in AR patients. Methods: In a multicenter, randomized, crossover, prospective study, 40 seasonal AR patients were administered both FFNS and MFNS for 2 weeks each in a crossover fashion, for a total of 4 weeks. Patients completed questionnaires for each product regarding perceived sensory attributes at the end of each two-week period of product administration. Results: FFNS was significantly preferred over MFNS. Significantly, fewer subjects perceived a bitter taste (p=0.01), medication running down their throat (p=0.033), and medication running out of their nose (p=0.002) with FFNS. MFNS was more frequently reported to induce nasal irritation (p=0.012), sneezing (p=0.017), and rhinorrhea (p=0.007) compared to FFNS. Interestingly, these findings were markedly observed in females. Medicine dripping out of the nose and nasal shooting were the most common problems reported for MFNS with a higher proportion of subjects who felt moderate-to-severe discomfort. Overall, 52.5% of patients expressed a preference for FFNS compared with 22.5% for MFNS. Conclusion: Several perceived sensory attributes of FFNS were rated significantly superior to MFNS. FFNS may contribute to enhanced treatment outcomes in AR patients due to improved treatment adherence.
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Intranasal corticosteroids are generally considered the most effective medication class for controlling allergic rhinitis. Previous comparative studies with oral antihistamines have been only partially informative due to a variety of variables encountered during their execution. To compare fluticasone propionate nasal spray (FPNS) with the second-generation antihistamine cetirizine (oral tablet) and with placebo in a head-to-head study in a 2-week treatment study during fall ragweed season. A total of 978 subjects were screened for this study. Six hundred and eighty-two subjects were randomized into the study (170 subjects, FPNS 200 mcg once daily; 170, cetirizine 10 mg once daily; 171, FPNS placebo; 171, cetirizine placebo) and comprised the intent-to-treat population. A 1-week placebo run-in was followed by a 2-week active treatment period during which time a total nasal symptom score (TNSS), total ocular symptom score, and the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire were collected. The primary efficacy end point was the mean change from baseline over the entire treatment period in A.M. reflective TNSS. The TNSS was the sum of the four individual nasal congestion, nasal itching, rhinorrhea, and sneezing scores, in which each symptom was scored on a scale of 0 to 3. Both FPNS and cetirizine improved the primary end point when compared with placebo during the active treatment period. Although there was a trend that favored FPNS with regard to the primary and secondary end points, there was not a statistical difference between the two treatments. FPNS and cetirizine were equally effective in treating fall seasonal allergic rhinitis during a 2-week head-to-head treatment investigation. Clinical trial NCT01916226, www.clinicaltrials.gov .
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Guidelines are the cornerstone of health care decision making and are based on the best available evidence, ideally large randomized controlled trials (RCTs). Although guidelines target typical patients, RCTs are often based on narrow inclusion and exclusion criteria. We explored to what extent typical patients, such as those consulting general practitioners for allergic rhinitis, differ from patients enrolled in RCTs. We conducted a prospective cohort study including all the consecutive patients with allergic rhinitis cared for by general practitioners in the Languedoc-Roussillon region of France within 2 weeks during the grass pollen season. We evaluated how the characteristics of these patients differed from those of patients included in the 4 largest placebo-controlled RCTs of persistent and intermittent allergic rhinitis. Three hundred eleven patients seen by 48 general practitioners were enrolled in this study. Only 7.4% (95% CI, 4.5% to 10.3%) of the patients would have been enrolled in the RCTs. The primary reasons for this difference were as follows: diagnosis of allergy based on skin test results, serum specific IgE levels, or both (20.4%); severity of allergic rhinitis (11.5%); other chronic diseases (11.4%); history of sinusitis (10.4%); and asthma comorbidity (10.1%). A sensitivity analysis excluding contraception and the diagnosis of allergy showed that the percentage of representative patients increased to 20.2% (95% CI, 15.8% to 24.7%). Only a small proportion of patients with allergic rhinitis seen in the primary care setting for allergic rhinitis would be eligible for RCTs. Thus guideline developers and health decision makers need to make careful judgments about the directness of the evidence from RCTs conducted in highly controlled settings.
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Allergic rhinitis represents a global health problem affecting 10% to 20% of the population. The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines have been widely used to treat the approximately 500 million affected patients globally. To develop explicit, unambiguous, and transparent clinical recommendations systematically for treatment of allergic rhinitis on the basis of current best evidence. The authors updated ARIA clinical recommendations in collaboration with Global Allergy and Asthma European Network following the approach suggested by the Grading of Recommendations Assessment, Development and Evaluation working group. This article presents recommendations about the prevention of allergic diseases, the use of oral and topical medications, allergen specific immunotherapy, and complementary treatments in patients with allergic rhinitis as well as patients with both allergic rhinitis and asthma. The guideline panel developed evidence profiles for each recommendation and considered health benefits and harms, burden, patient preferences, and resource use, when appropriate, to formulate recommendations for patients, clinicians, and other health care professionals. These are the most recent and currently the most systematically and transparently developed recommendations about the treatment of allergic rhinitis in adults and children. Patients, clinicians, and policy makers are encouraged to use these recommendations in their daily practice and to support their decisions.
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Perennial allergic rhinitis (PAR) affects children at a young age. Current guidelines recommend intranasal corticosteroids as the first-line treatment in patients with moderate-to-severe or persistent disease or in those who have congestion. In this study, the long-term safety and efficacy of mometasone furoate nasal spray (MFNS) were assessed in children with PAR. In this multicenter, active-controlled, evaluator-blind, 12-month study, 255 children aged 6-11 years with a >or=1-year history of PAR were randomized to receive once-daily MFNS 100 microg (n=166) or the active comparator beclomethasone dipropionate (BDP) 168 microg (n=85). Changes from baseline in overall PAR symptoms and response to treatment were rated at each visit. Cosyntropin stimulation testing, as well as tonometry and slit lamp procedures, were performed. Safety variables were assessed. A total of 137 subjects in the MFNS group and 68 in the BDP group completed treatment. The mean reductions in physician- and subject-rated overall condition of PAR at week 52 were -42.1% and -39.7%, respectively, for MFNS, compared with -44.0% and -39.0%, respectively, for BDP. A total of 94% and 100% of MFNS and BDP subjects, respectively, reported adverse events (AEs), which were mostly mild or moderate. The most frequently reported treatment-related AEs in both groups were epistaxis, headache, and pharyngitis. Response to cosyntropin was normal and no posterior subcapsular cataracts were observed in either group. Although no significant changes in intraocular pressure were observed with MFNS, one subject receiving BDP demonstrated this effect. Treatment with MFNS 100 microg once daily for 1 year was well tolerated in children 6-11 years old, with negligible systemic exposure and no evidence of suppression of the hypothalamic-pituitary-adrenal axis or ocular changes.