EQUIVALENCE OF ASTHMA CONTROL WITH NEW CFC-FREE FORMULATION HFA-134A BECLOMETHASONE DIPROPIONATE AND CFC-BECLOMETHASONE DIPROPIONATE

The study was designed to test for equivalence of asthma control betwe en a new aerosol formulation of beclomethasone dipropionate (BDP) inco rporating a chlorofluorocarbon-(CFC) free, hydrofluoroalkane propellan t (HFA-134a) and the conventional beclomethasone aerosol formulated in CFC propellants. Sixty-eight asthmatic patients entered an eight-week , randomised, double-blind crossover study. All patients, previously s tabilised on BDP, were randomised to receive the same dose of BDP from each of the study treatments. Statistically significant equivalence w as demonstrated between HFA-BDP and CFC-BDP for asthma control paramet ers: FEV(1), morning and evening PEF, sleep disturbance, wheeze and co ugh, morning breathlessness and bronchodilator use. Such equivalence w as also demonstrated for safety parameters. To conclude, it has been d emonstrated that HFA-BDP achieves a level of asthma control that is cl inically and statistically equivalent to CFC-BDP in terms of efficacy and safety, at total daily doses ranging from 200 mu g to 600 mu g in asthma patients previously stabilised on inhaled CFC-BDP.