Efficacy and safety of beclomethasone dipropionate extrafine aerosol in childhood asthma - A 12-week, randomized, double-blind, placebo-controlled study

Background: Beclomethasone dipropionate (BDP) has been formulated as an extrafine aerosol (hydrofluoroalkane-134a [HFA]-BDP) [QVA-R; 3M Pharmaceuticals; St Paul, MN], which gives improved lung deposition compared with chlorofluorocarbon (CFC)-BDP. The clinical efficacy of HFA-BDP has been established in adult asthma at a required dose below that of CFC-BDP, but has not been evaluated in children. Objective: To examine the efficacy and safety of HFA-BDP in childhood asthma. Design: A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study involving 353 children aged 5 to 12 years with moderate, symptomatic asthma. After a 2-week run-in period, patients were randomized to HFA-BDP, 80 mug/d (n=120); HFA-BDP, 160 mug/d (n=117); or HFA-placebo (n=116) administered twice daily. Setting: Hospital outpatient. Results: HFA-BDP, 80 mug/d and 160 mug/d, produced a significant, dose-related increase from baseline in FEV1 percent predicted compared with placebo. At week 12, mean changes from baseline in FEV1 percent predicted were 9.2% (pless than or equal to0.01 vs placebo), 10% (pless than or equal to0.01 vs placebo), and 3.9% for the HFA-BDP 80 mug/d, HFA-BDP 160 mug/d, and placebo groups, respectively. There was also a significant decrease in daily P-agonist use, improvement in peak expiratory flow, and reduction in the percentage of days free from asthma symptoms (pless than or equal to0.05 for HFA-BDP, 160 mug/d, vs placebo at weeks 11 to 12). HFA-BDP was well tolerated, with no significant differences in the incidence or nature of adverse events between HFA-BDP and placebo groups. Neither were there significant differences between groups in mean percentage change from baseline in the morning plasma cortisol level at week 12 or in the percentage of patients with morning plasma cortisol levels below the reference range at baseline and week 12. In a subgroup tested, the percentage of patients with an abnormal response to low-dose adrenocorticotropic hormone stimulation at week 12 was low and similar among all groups. Conclusions: HFA-BDP, 80 to 160 mug/d, is effective and safe in childhood asthma.