David P. Skoner's research while affiliated with West Virginia University and other places
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Publications (320)
All drugs have potential side effects, but thoughtful use can maximize benefits while minimizing risks. Children should not be considered just “small adults” regarding drug safety, as their growth and development are discordant with their ability to sense and self-report drug side effects. Detecting side effects requires vigilance and education fro...
Background:
Intranasal corticosteroids (INCS) are the cornerstone of treatment for chronic rhinosinusitis. Although INCS are generally considered safe and effective, there is a concern that chronic use may lead to ocular adverse effects.
Objective:
To assess ocular safety of the exhalation delivery system with fluticasone propionate (EDS-FLU) in...
Objective: Asthma Action Plans (AAP) are recommended to guide asthma management. Written AAPs (WAAPs) are under-utilized and can be difficult to understand. Our study designed and tested a simplified, pictorial AAP (PAAP). We hypothesized that better outcomes would be obtained for youth with the PAAP.
Methods: 169 youth (aged 8-17; AAP-naïve) were...
BACKGROUND
Limited comparative data are available on impact of systemic corticosteroid (SCS) use in children and adolescents.
OBJECTIVE
To determine if asthmatic children and adolescents treated with SCS have a higher likelihood of developing complications versus those not receiving SCS and to examine healthcare resource utilization (HCRU) in this...
Introduction
Outdoor air pollution (OAP) contributes to poor asthma outcomes and remains a public health concern in Pittsburgh. The purpose of this study was to determine the prevalence of childhood asthma and its rate of control among Pittsburgh schoolchildren residing near OAP sites.
Methods
Participants were recruited from schools near OAP site...
Background:
An Asthma Adherence Pathway (AAP) application, which is an Internet application that combines patient and clinician education strategies to promote adherence to asthma therapy, has been developed.
Objective:
The primary objective of this pilot study was to evaluate the effectiveness of the AAP application with electronic adherence mo...
Introduction
Increased intraocular pressure (IOP) and cataracts are known risks of systemic steroid exposure. EDS-FLU (exhalation delivery system with fluticasone) 372mcg produces higher systemic exposure than fluticasone nasal spray 400mcg, but lower systemic exposure than orally inhaled fluticasone 440mcg. Ocular effects were extensively studied...
Background:
Asthma is an important focus for pediatric health research as management of asthma symptoms is a significant challenge, and morbidity and mortality among youths with asthma remain prevalent. Treatment guidelines for asthma recommend a written asthma action plan (WAAP) that summarizes individualized instructions for daily medication use...
BACKGROUND
Asthma is an important focal point for health-focused research as ineffective symptom management and control can lead to significant morbidity and mortality. Current treatment guidelines for asthma recommend the use of a written asthma action plan (WAAP) to include individualized instruction for daily care and medication use. However, WA...
Background:
Large sample sizes are needed for sublingual immunotherapy (SLIT) trials due to inherent data variability secondary to inconsistent allergen exposure. Obtaining large sample sizes for pediatric SLIT trials is challenging, but a Bayesian approach using prior adult data can reduce the necessary sample size.
Objective:
To describe how a...
Background:
Adults and adolescents were included in 3 phase 3 omalizumab trials in chronic idiopathic urticaria (CIU): ASTERIA I, ASTERIA II, and GLACIAL.
Objective:
To describe the baseline clinical profile of adolescent patients with CIU enrolled in the omalizumab trials to add to the limited literature available on CIU in this population.
Me...
Background:
Both slowed growth in children and reduced bone mineral density (BMD) are systemic effects of corticosteroids, and there is concern about the degree to which these systemic effects affect growth and BMD.
Objective:
To engage in a data-driven discussion of the effects of inhaled corticosteroids (ICSs) on growth in children and BMD.
M...
Background:
Earlier 1-year growth studies that used older inhaled corticosteroid (ICS) formulations consistently showed that ICS, but not intranasal corticosteroids (INCS), produced a small 1 cm/y growth effect that appeared to be nonprogressive and noncumulative. Studies that lasted for 1 year showed that such treatment during childhood did not a...
Sublingual immunotherapy (SLIT) is a safe and effective treatment for allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC). The Food and Drug Administration (FDA) in the USA has approved three SLIT tablets for the treatment of AR and ARC in relation to pollen. Specifically, Grastek® and Oralair® are two formulations approved to treat patie...
To identify the prevalence of asthma, obesity, hypertension, and environmental tobacco smoke (ETS) exposure among youth and provide recommendations for follow-up care.
This cross-sectional study consisted of 12 health screenings for children between 5 and 17 years of age in various inner city, lower socioeconomic, and predominantly black communitie...
Chronic rhinosinusitis (CRS) and asthma frequently coexist in children and adults. However, the precise pathophysiologic mechanism of this interaction is still poorly understood, especially in children, owing to the lack of direct measurements of mucosal inflammation in the upper airways.
To determine the pathophysiologic mechanism by analyzing the...
Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acet...
Objective:
To evaluate the effectiveness of asthma education delivered by student pharmacists and to assess the impact of child and caregiver baseline asthma knowledge on asthma control in children.
Design:
Student pharmacists developed and implemented asthma self-management education interventions for children and their caregivers and performed...
Background
Patients with asthma may be more susceptible to adverse events (AEs) with sublingual immunotherapy tablet (SLIT-tablet) treatment, such as severe systemic reactions and asthma-related events. Using data from 8 trials of grass SLIT-tablet in subjects with allergic rhinitis with/without conjunctivitis (AR/C), AE frequencies were determined...
Background
The practices and beliefs of the provider specialties that treat allergic rhinoconjunctivitis (ARC) with allergen immunotherapy (AIT) may vary.MethodsA telephone survey of 500 randomly selected health care practitioners in 7 specialties, conducted in 2012.ResultsAIT was provided as a subcutaneous injection (SCIT) by 91% of allergist/immu...
Purpose of review:
Sublingual immunotherapy (SLIT) is indicated for the use in pediatric patients suffering from allergic rhinitis or allergic rhinoconjunctivitis caused by environmental allergens, such as ragweed pollen, grass pollen, and dust mite. This review focuses on recent and relevant studies associated with the use of SLIT for these aller...
The effect of cetirizine on quality of life (QOL) in subjects with perennial allergic rhinitis (PAR) has been previously evaluated using generic instruments. While generic QOL tools are used across various conditions, disease-specific instruments evaluate the impact of treatment on areas that are affected by that COPY particular condition. This stu...
Previous nationwide surveys of allergies in the United States have focused on nasal symptoms, but ocular symptoms are also relevant. This study determines the effects of ocular and nasal allergies on patients' lives. Telephone surveys of randomly selected U.S. households (the patient survey) and health care providers (provider survey) were conducte...
Background
The bronchodilatory effect of mometasone furoate/formoterol fumarate (MF/F) administered by metered-dose inhaler (MDI) with or without a spacer has not been evaluated previously in children aged 5-11 years. Methods
This was a randomized, multicenter, placebo-controlled, single-dose, four-period crossover study. Children with persistent a...
Allergen immunotherapy (AIT) is used for the treatment of allergic rhinoconjunctivitis as a subcutaneous injection (subcutaneous immunotherapy [SCIT]). Extracts used for SCIT are also used off-label to formulate a liquid delivered as sublingual drops (sublingual immunotherapy [SLIT]). This study was designed to survey patients' experiences and beli...
Allergic rhinoconjunctivitis (ARC) is managed by a number of health care professional specialties, whose practice styles may vary.
To survey patients and health care professionals about the diagnosis and treatment of ARC.
The Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) surveys were telephone surveys of randomly selected patients and he...
Allergic diseases are common in pediatrics and can be caused by seasonal pollens, specifically grass, trees, and weeds. In many European countries, sublingual immunotherapy (SLIT) is an accepted form of treatment for allergic rhinitis. However, the Food and Drug Administration (FDA) has not yet approved its use in the United States. This review foc...
In North America, few studies have evaluated sublingual immunotherapy for allergic rhinitis with or without conjunctivitis (AR/C); pediatric data are sparse. The authors report findings from the largest published immunotherapy trial yet conducted in adults and children.
To evaluate grass sublingual immunotherapy tablet (MK-7243) treatment in subjec...
Background:
The prevalence of asthma and obesity in children has increased over the past several years, with obesity being associated with higher rates of asthma. In response to known disparities in asthma prevalence and morbidity, along with barriers to diagnosis, assessment and education, a comprehensive asthma sports camp series was developed a...
Inhaled corticosteroids (ICSs) are an effective therapy for the treatment of persistent asthma of all severities because they reduce symptoms, improve lung function, and reduce underlying inflammation. Although ICSs are generally safe for long- term use, there is concern among physicians and patients about potential systemic side effects, including...
Background
Allergic rhinitis (AR) is a common pediatric problem that significantly affects sleep, learning, performance, and quality of life. In addition, it is associated with significant comorbidities and complications.
Objective
The aim was to provide an update on the epidemiology, comorbidities, pathophysiology, current treatment, and future d...
To assess the effects of long-term mometasone furoate delivered via a dry powder inhaler (MF-DPI) on growth velocity and hypothalamic-pituitary-adrenal axis function in children with asthma.
Children aged 4-9 years with asthma (n = 187) were randomized to MF-DPI 100 μg (delivered dose; actuated dose is 110 μg) once daily in the morning (QD AM), 100...
Sublingual immunotherapy (SLIT) is a well-established treatment option for allergic rhinitis in several European countries, but it is considered investigational in the United States. Studies conducted in Europe provided a large body of evidence supporting the safety and efficacy of SLIT, but those studies used allergen products that are different f...
Evidence supports a bidirectional relationship between stress and asthma exacerbations in children, suggesting that interventions to reduce stress may improve both psychosocial quality of life and disease course. Here, we examine the feasibility of a stress management intervention for 7- to 12-year-olds with asthma.
Two trials were conducted. Cohor...
Allergy immunotherapy tablet (AIT) treatment might be a safe and convenient form of specific immunotherapy but it has not been investigated in North American children and adolescents.
We sought to investigate the efficacy and safety of timothy grass AIT treatment in North American children/adolescents with grass pollen-induced allergic rhinoconjunc...
Small-particle inhaled corticosteroid (ICS) metered-dose inhalers were recently developed to treat asthma as part of the CFC to HFA propellant switch mandated by the Montreal Protocol. Two such ICS, beclomethasone dipropionate (BDP) and ciclesonide (CIC), are available in the United States and are formulated in HFA solutions. A major advantage of s...
Specific allergen immunotherapy is most often delivered subcutaneously, but sublingual immunotherapy may confer greater benefit in terms of tolerability and safety, accessibility, and improved antigen delivery.
This randomized, double-blind, placebo-controlled trial was conducted to identify a safe and effective maintenance dose range of sublingual...
Corticosteroids are the foundation of pharmacologic treatment for children with asthma. However, high-dose inhaled corticosteroid treatment can cause hypothalamic-pituitary-adrenal (HPA) axis suppression. We investigated the effect of three doses of mometasone furoate administered via dry-powder inhaler (MF-DPI) on the HPA axis in children. Fifty c...
Otitis media (OM) is a common and costly medical condition, especially in children. Most episodes of OM are associated with an upper respiratory viral infection and are short-lived and self-limiting with or without medical treatment. However, chronic OM with effusion (OME) has significant sequelae, is refractory to most medical treatments, and freq...
Inhaled corticosteroids are used widely to treat asthma. A number of different steroids and inhalation devices are available. The pharmacokinetic and pharmacodynamic properties of the different inhaled corticosteroids may influence their efficacy and safety profiles. Properties of an ideal inhaled corticosteroid include low oropharyngeal deposition...
Inhaled corticosteroids (ICS) are the guideline-preferred preventative therapy for persistent asthma of all severity levels and for all ages, including children. While these drugs are unquestionably efficacious, concerns of adverse systemic effects limit patient compliance with treatment regimens and thus the attainable benefits. Suppression of bon...
Otitis media (OM) and sinusitis are common and costly maladies that are often preceded by the development of a viral upper
respiratory infection (vURI). Although antibiotics have been shown to be somewhat effective in the treatment of these disorders,
increasing concern over the emergence of pathogen resistence to these agents underscores the need...
Ciclesonide is a novel inhaled corticosteroid used in the continuous treatment of mild-to-severe asthma. Its formulation and mechanism of action yield a low oral and systemic bioavailability, and high pulmonary deposition. In multiple clinical trials, ciclesonide is at least as effective as either fluticasone propionate or budesonide at symptom con...
Results: Of 117 children assigned to the OT group, 100 completed follow-up; of 115 assigned to the OT with a prescription group, 106 completed follow-up. In the OT group, 87 parents reported no antibiotic use within the 3-day observation period, compared with 66 parents in the prescription group. During the entire study period, 81% of the OT group...
Guidelines recommend treatment with intranasal corticosteroids for patients with allergic rhinitis (AR), but concerns remain about possible adverse effects.
To present the 1- and 2-year growth results for children with AR treated with triamcinolone acetonide aqueous nasal spray.
Thirty-nine children (aged 6.1-14.3 years at study entry) were treated...
PURPOSE: Current treatment guidelines recommend inhaled corticosteroids (ICS) as the cornerstone of asthma treatment in children. However, the majority of studies investigating ICS efficacy, safety, and ease-of-use have been performed in adolescent or adult populations. The safety of mometasone furoate administered via a dry powder inhaler (MF-DPI)...
This study assessed the efficacy and safety of guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg extended-release bilayer tablets in providing relief of acute respiratory symptoms when used as an adjunct to antibiotics in patients with an acute respiratory infection (ARI).
Adult patients experiencing symptoms of ARI and meeting the physici...
Inhaled corticosteroids (ICSs) are the preferred first-line preventative therapy for asthma of all severity levels. Although these drugs have been proven efficacious, concerns of adverse systemic affects due to both long- and short-term use continue to limit patient compliance with dosing regimens. Deficits in bone growth, bone density, and hypotha...
IntroductionOtitis MediaSinusitisReferences
To assess the effects of the new inhaled corticosteroid ciclesonide on growth in children with asthma.
We performed a multicenter, randomized, double-blind, placebo-controlled study to assess the effects of inhaled ciclesonide on growth in children with mild, persistent asthma. After a 6-month run-in period, 661 prepubertal children who were aged 5...
Citations
... Although INCS are considered the cornerstone of treatment for chronic rhinosinusitis and are generally considered safe, there is some concern that chronic use may lead to ocular adverse effects, such as increased intraocular pressure. To assess ocular safety of the exhalation delivery system (EDS) with fluticasone propionate in patients with chronic rhinosinusitis with nasal polyps, Skoner et al. 42 collected ocular safety data during two randomized, double-blind, placebo controlled studies with open-label extensions. They report that no increased risk of elevated intraocular pressure was detected with EDS-fluticasone propionate; the rate of cataract development was similar to EDS-placebo and to that reported with other INCS. ...