Safety and efficacy of HFA-134a beclomethasone dipropionate extra-fine aerosol over six months

Abstract

Objective: To compare the systemic safety and efficacy of hydrofluoroalkane beclomethasone dipropionate (HFA-BDP) extra-fine aerosol 800 μg/day with chlorofluorocarbon (CFC)-BDP 1500 μg/day. Design: Six-month, randomized, parallel-group, double-blind, double-dummy study. Patients: Patients (n=141) with moderate to severe asthma adequately controlled by CFC-BDP 1000 μg/day to 2000 μg/day. Interventions: Patients received CFC-BDP 1500 μg/day during a two-week run-in period and were then randomized to either HFA-BDP (n=70) or CFC-BDP (n=71). Results: Similar proportions of HFA-BDP and CFC-BDP patients had a 24 h urinary free cortisol values below the reference range at month 6 (15% versus 25%, P=0.35). Measures of adrenocorticotrophic hormone stimulation and morning plasma cortisol levels were also similar in each group. The frequency of skin bruising and oral candidiasis was low for both treatments. No change in intraocular pressure was reported for either treatment. Pulmonary function was similar in both groups; however, the onset of the first asthma exacerbation or increased asthma symptoms tended to be earlier for CFC-BDP than for HFA-BDP (P=0.076); 27% of CFC-BDP patients reported increased asthma symptoms, compared with 14% of HFA-BDP patients (P=0.095). Conclusions: HFA-BDP 800 μg/day has a systemic adverse event profile comparable to that of CFC-BDP 1500 μg/day, and further control of asthma symptoms may be achieved after a switch from CFC-BDP 1500 μ g/day to HFA-BDP 800 μg/day. © 2004 Pulsus Group Inc. All rights reserved.