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New Formulation of Aqueous Flunisolide Nasal Spray in the Treatment of Allergic Rhinitis: Comparative Assessment of Safety, Tolerability, and Efficacy

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Abstract:

This 6-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial compared the safety, efficacy, and tolerability of a new formulation of flunisolide nasal spray with the original formulation in the treatment of allergic rhinitis due to mountain cedar pollenosis. It was conducted at three clinical centers in close geographic proximity. A total of 216 patients, ranging in age from 14 to 77 years (mean, 44 years), took at least one dose of study drug and therefore were evaluable for the safety analysis. A total of 185 patients (85%) completed the study, and 136 patients were evaluable for the efficacy analysis. Both formulations of flunisolide were comparable in terms of relief of rhinitis symptoms, and the new flunisolide formulation was better tolerated than the original formulation. Both active formulations were superior to their respective vehicles (P < 0.001) using multiple measures of allergic rhinitis symptoms relief Use of escape medication (chlorpheniramine maleate) was significantly (P ≤ 0.034) greater in the placebo group when compared with their respective active treatment groups. No therapeutic effect was observed with symptoms of allergic conjunctivitis. Significantly fewer patients who were treated with the new formulation flunisolide reported nasal burning and stinging when compared with the original formulation (P = 0.006). In conclusion, the new formulation showed similar efficacy and improved tolerability in the treatment of allergic rhinitis compared with the original formulation. This new formulation not only offers clinicians a useful therapeutic addition for the treatment of allergic rhinitis, but may also improve patient compliance.

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/108854196779165049

Publication date: May 1, 1996

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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