Hydrofluoroalkane-134a beclomethasone dipropionate, 400 μg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 μg, for the treatment of moderate asthma

Objective: The improved lung deposition of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) extrafine aerosol compared with chlorofluorocarbon beclomethasone dipropionate (CFC-BDP) suggests that lower doses of HFA-BDP may be required to provide equivalent asthma control. The present study was undertaken to test this hypothesis. Design: A 10- to 12- day run-in period confirmed that patients met established criteria of at least moderate asthma and the asthma was inadequately controlled by current therapy (inhaled β-agonist and CFC-BDP [≤ 400 μg/d]). A short course of oral prednisone, 30 mg/d for 7 to 12 days, was followed to establish the patients were steroid responsive and to provide an 'in-study' baseline of 'optimal' asthma control. Patients: A total of 347 patients were then randomized to HFA-BDP 400 μg/d, CFC-BDP 800 μg/d, or HFA-placebo for 12 weeks. Results: Morning peak expiratory flow (AM PEF) measurements showed that HFA-BDP 400 μg/d achieved equivalent control of asthma to CFC-BDP 800 μg/d at all time intervals after oral steroid treatment. All other efficacy variables supported the AM PEF results and both active treatments were more effective than placebo. The safety profile of HFA-BDP compared favorably with that of CFC-BDP with no unexpected adverse events reported. Conclusions: These findings demonstrate that HFA-BDP provides equivalent control of moderate or moderately severe asthma as CFC-BDP in the population studied, but at half the total daily dose.