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.
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 µg/d), BDP 42, four oral inhalations bid (336 µg/d), or placebo. A fourth treatment arm administering BDP 84, eight oral inhalations bid (HD BDP 84; 1,344 µg/d) was also included to determine whether a dose-response relationship could be demonstrated.
Measurements: Spirometry, clinical observations.
Results: The three active treatments were significantly more effective (p≤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 µg/d and 1,344 µg/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.