Efficacy and Safety of Extrafine Beclomethasone Dipropionate Aerosol Therapy in Children with Asthma: A Twelve-Week Placebo-Controlled Trial

Abstract

This multicenter study investigated whether beclomethasone dipropionate in hydrofluoroalkane-134a propellant (HFA-BDP) is effective in controlling asthma in children at a total dose as low as 100 μg/d. A group of 319 children with mild to moderate asthma, ranging in age from 6 to 12 years, were randomly assigned to receive double-blind treatment with HFA-BDP, 50 μg twice daily; HFA-BDP, 100 μg twice daily; or HFA-placebo for 12 weeks. The Maxair™ Autohaler™ (3M Pharmaceuticals) inhalation device was used to facilitate medication delivery. Median compliance with study medication was 62.5% in the intent-to-treat population, and was lower in the HFA-BDP 200 μg/d group (55.8%) compared to the HFA-BDP 100 μg/d (67.0%) and placebo (66.0%) groups. Median compliance was 80.0% in the evaluable-for-efficacy population. Mean change from baseline at week 12 in forced expiratory volume in 1 second (FEV1) percent predicted was significantly greater than placebo in the HFA-BDP 100 μg/d group (p ≤ 0.01) but not the 200 μ...