A comparison of double-strength beclomethasone dipropionate (84 mu g) MDI with beclomethasone dipropionate (42 mu g) MDI in the treatment of asthma

Study objective: To compare the efficacy and safety of a double-strength formulation of beclomethasone dipropionate (BDP 84) metered-dose inhaler (MDI) with that of beclomethasone dipropionate (BDP 42) MDI in the treatment of chronic asthma. Design: A 28-day, randomized, double-blind, double-dummy, placebo-controlled, multicenter study. Setting: Outpatient. Patients: A total of 423 patients aged 12 to 65 years (mean range, 34 to 36 years) with moderate asthma (FEV1, 50 to 80% of predicted) who required long-term inhaled corticosteroids were enrolled. Interventions: Patients were randomized to receive BDP 84, two oral inhalations bid (336 mu g/d), BDP 42, four oral inhalations bid (336 mu g/d), or placebo. A fourth treatment arm administering BDP 84, eight oral inhalations bid (HD BDP 84; 1,344 mu g/d) was also included to determine whether a close-response relationship could be demonstrated. Measurements: Spirometry, clinical observations. Results: The three active treatments were significantly more effective (p less than or equal to 0.01) than placebo at all time points in improving FEV1, the primary efficacy parameter; BDP 42 and BDP 84 were comparable to each other at every time point. Secondary pulmonary function tests (FVC, forced expiratory flow at 25 to 75% of FVC, and peak expiratory flow rate) showed similar results. All three active treatments were well tolerated. A dose response between 336 mu g/d and 1,344 mu g/d was demonstrated. Conclusion: in this well-controlled 28-day study, BDP 42 and BDP 84 were shown to be comparable in efficacy and safety on a microgram-for-microgram basis.