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 μg/d group in both the intent-to-treat and evaluable-for-efficacy analyses. In the evaluable-for-efficacy analysis, there was a significant trend for increasing median change from baseline in FEV1 as percent predicted with increasing doses of HFA-BDP (p < 0.0001). A cumulative distribution plot demonstrated a greater response to HFA-BDP 200 μg/d among those patients in the evaluable-for-efficacy analysis, which was the subset of patients who were compliant with treatment, compared to those in the intent-to-treat analysis, who were less compliant. In conclusion, HFA-BDP, 100 μg/d, demonstrated superior efficacy to placebo in improving asthma control in children with mild to moderate asthma. Compliance was particularly low in the 200 μg/d group, suggesting insufficient data to determine efficacy for this dose. However, further analysis supported the efficacy of this dose in patients who used their medication as instructed.
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