Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma.

Background: Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standard metered-dose inhalers (MDI). Objective: To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI. Methods: This 6-week, phase III, double-blind study included patients aged >= 12 years with persistent asthma. During the single-blind run-in, patients discontinued asthma medications and received twice-daily placebo BAI or MDI. At randomization, BAI patients received BDP BAI 320 mu g/day, BDP BAI 640 mu g/day, or placebo BAI, and MDI patients received BDP MDI 320 mu g/day or placebo MDI. Assessments included standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from 0 to 6 weeks (AUEC([0-6 wk])) (obtained by clinic-based spirometry; the primary end point), morning peak expiratory flow (PEF), trough daily morning FEV1 (obtained by handheld spirometry), withdrawals, and tolerability. Results: Of 425 patients randomized, most were white (81%) and female (61%). BDP BAI 320 and 640 mu g/day significantly improved FEV1 AUEC(0-6 wk) versus placebo (p < 0.001). The BDP BAI treatment groups exhibited significantly improved morning PEF and daily morning FEV1 versus placebo (p < 0.001). Similar treatment effects were demonstrated for BDP MDI (p < 0.001). Fewer patients withdrew due to worsening asthma while taking BDP BAI 320 mu g/day (n = 1), BDP BAI 640 mu g/day (n = 0), and BDP MDI 320 mu g/day (n = 1) versus placebo (n = 10). BDP BAI was well tolerated. Conclusion: BDP BAI demonstrated significant improvements in pulmonary function versus placebo, with results similar to BDP MDI. The safety profile of BDP BAI was comparable to BDP MDI, with no new safety signals.