HYDROFLUOROALKANE-134A BECLOMETHASONE DIPROPIONATE EXTRAFINE AEROSOL PROVIDES EQUIVALENT ASTHMA CONTROL TO CHLOROFLUOROCARBON BECLOMETHASONE DIPROPIONATE AT APPROXIMATELY HALF THE TOTAL DAILY DOSE

The mandatory requirement to eliminate chlorofluorocarbons (CFCs) as p ropellants in pharmaceutical aerosols has provided the opportunity to enhance significantly the delivery of aerosol drugs to the respiratory tract. This randomized, parallel-group, double-blind, double-dummy, m ulticentre study was undertaken to assess whether beclomethasone dipro pionate (BDP) in hydrofluoroalkane-134a (HFA) provided equivalent cont rol of moderately severe asthma to BDP in CFC hut at approximately hal f the total daily dose, as might be expected from the improved lung de position of the HFA-BDP extrafine aerosol. The novel study design incl uded a 10-12 day run-in period to confirm that patients met establishe d criteria of moderately severe asthma and were symptomatic on current therapy (inhaled beta-agonist plus CFC-BDP 400-800 mu g day(-1)). Thi s run-in period was followed by a short course of oral steroid therapy (prednisolone 30 mg day(-1) for 7-13 days) to demonstrate steroid res ponsiveness [greater than or equal to 15% improvement in morning peak expiratory flow (PEF)] and to provide a within-study baseline of impro ved asthma control. A total of 233 patients were randomized to treatme nt for 12 weeks with HFA-BDP 800 mu g day(-1) (116 patients) or CFC-BD P 1500 mu g day(-1) (117 patients). The mean change from oral steroid treatment in morning PEF with HFA-BDP was equivalent to that seen with CFC-BDP at all time intervals. Changes in other measures of pulmonary function, asthma symptom scores and beta-agonist use were equivalent in the two treatment groups throughout the 12 week treatment period. T he safety profile of HFA-BDP compared favourably with that of CFC-BDP with no unexpected adverse events reported. Fewer patients on HFA-BDP than on CFC-BDP had plasma cortisol levels below the normal reference range after 12 weeks of therapy (5.1% vs. 17.3%, respectively). In con clusion, HFA-BDP extrafine aerosol was found to provide equivalent con trol of moderately severe asthma to CFC-BDP at approximately half the daily dose with a favourable safety profile, suggesting an improved th erapeutic ratio.