METHODS: Phase 3, 6-week, double-blind, placebo-controlled trial (NCT02513160) evaluated efficacy of BDP BAI in patients ≥12 years with persistent asthma. Following a 14- to 30-day single-blind run-in period (asthma medication discontinued), patients were randomized to BDP BAI (320 mcg/day, 640 mcg/day), BDP metered dose inhaler (MDI) 320 mcg/day or placebo. Daily trough morning forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF) were evaluated pre-dose by handheld spirometry at home. Safety was monitored.
RESULTS: Primary and secondary endpoints were statistically significant with active treatments versus placebo. Change from baseline in weekly average of daily trough morning FEV1 was significant for active treatments versus placebo over 6-weeks (p<0.001). Weekly average of daily trough morning PEF also demonstrated significant changes from baseline versus placebo over 6-weeks (p<0.001). Post-hoc analysis evaluated 425 patients. Differences from placebo were revealed for FEV1 and PEF with active treatments starting day 1 (BAI 320 mcg/day: 129 mL, 14.3 L/min; BAI 640 mcg/day: 71.9 mL, 14.9 L/min; MDI 320 mcg/day: 89.4 mL, 9.5 L/min, respectively) and maintained throughout the treatment period. Sustained onset of action (significant change in FEV1 over two consecutive days versus placebo) was observed starting day 2. No new safety signals.
CONCLUSIONS: Treatment effect of BDP BAI was evident as early as day 1 and maintained for the 6-week treatment period.