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Establishing the onset of action of intranasal corticosteroids: Is there an ideal study design?

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Intranasal corticosteroids (INs) are considered the most effective pharmaceutical treatments for nasal allergic rhinitis (AR) symptoms and are recommended as first-line therapy for moderate-to-severe symptoms. United States Food and Drug Administration (FDA) guidelines for clinical development of drug products for AR describe three study types used to determine medication onset of action: (1) standard phase 3 efficacy studies, (2) park-setting studies, and (3) environmental exposure chamber studies. This study was designed to review the U.S. FDA guidelines and discuss published studies of each type examining INS onset of action. Medline searches were conducted using the terms “onset of action” and each of the following: “beclomethasone,” “budesonide,” “ciclesonide,” “fluticasone furoate,” “fluticasone propionate,” “mometasone furoate,” and “triamcinolone.” Studies included in the analysis were of subjects with seasonal or perennial AR; were double-blind, placebo-controlled, and randomized; and reported onset-of-action data. Published studies of all three types describing INS onset of action vary widely in compliance with guideline recommendations and in the calculated onset of these medications. The usefulness of the study types used to assess AR therapies—standard efficacy, park setting, and environmental exposure chamber—can be assessed based on each study's ability to reproduce real-world settings, limit variability of allergen exposure, limit variation in study design, and ensure patient adherence to study drug. Studies conducted in an environmental exposure chamber to determine onset of action for INSs may be of superior design because outcomes are significantly less variable and more reproducible than those of other types.
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Keywords: Allergic rhinitis; environmental exposure chamber; intranasal corticosteroids; onset of action; park study; perennial allergic rhinitis; seasonal allergic rhinitis; study design; total nasal symptom score

Document Type: Review Article

Affiliations: Weinberg Clinical Research Unit, National Jewish Health and University of Colorado Denver Anschutz Medical Campus, Denver, Colorado, USA. [email protected]

Publication date: 2009-11-01

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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