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| |  Study of Nebulisable Budesonide for Oral Inhalation of Paediatric Asthma Fails to Meet Coprimary Endpoints: Presented at ATS By Cathy Yarbrough SAN DIEGO -- May 20, 2009 -- A phase 3 trial of a novel aqueous nebulised dispersion of budesonide for oral inhalation in the treatment of asthma in young children (CASTLE I), failed to meet its coprimary endpoints, researchers reported here at the International Conference of the American Thoracic Society (ATS). The composite symptoms score from the trial revealed that neither of the 2 doses administered to the 2 treatment patient groups was statistically different from placebo. In addition, an unexpectedly large placebo effect was observed early and was maintained throughout the study. Unit Dose Budesonide (UDB) delivered via a jet nebuliser was designed to provide faster, more consistent medication delivery and efficacy at doses lower than conventional nebulised budesonide. According to Alan H. Cohen, MD, MAP Pharmaceuticals, Mountain View, California, and colleagues, UDB's positive effect on paediatric asthma patients was supported by subgroup analyses and the trial's meeting such secondary endpoints as time to asthma deterioration and peak expiratory flow rate. "Overall the results of the CASTLE I study suggest that UDB may be potentially efficacious in treating paediatric asthma, while providing a faster nebulisation time and a lower total administered dose of corticosteroid," the authors wrote in their poster, which was presented on May 18. During the 12-week randomised, double-blind, placebo-controlled, parallel-group study, 360 asthmatic infants and children, aged 12 months to 8 years, were treated with 2 doses of UDB. A total of 122 patients received UDB 0.135 mg, and 117 patients were treated with UDB 0.25 mg. The placebo group was comprised of 110 patients. Three daytime and nighttime symptom scores (primary endpoints) were recorded by a parent/caretaker, in the morning and the evening, to reflect the previous 12 hours of symptoms. Individual symptom scores ranged from 0 (no symptoms) to 3. Composite symptom scores (sum of all 3 scores for daytime or nighttime) ranged from 0 to 9. Baseline symptom scores were 2.73 to 2.96 and 2.71 to 2.97 for daytime and nighttime measures, respectively. At week 12, the UDB 0.13- mg treatment group scores were: -0.21 and -0.18 difference from placebo for daytime and nighttime composite scores, respectively. For the UDB 0.25-mg group: -0.06 and -0.04 difference from placebo for daytime and nighttime composite scores, respectively. Funding for this study was provided by MAP. [Presentation Title: Unit Dose Budesonide (UDB): A New Submicron Dispersion of Nebulizable Budesonide Studied in 360 Children 12 Months to 8 Years With Mild to Moderate Persistent Asthma--The CASTLE I Study. Poster J47]
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