METHODS: Phase 3, 6-week, randomized, double-blind, placebo-controlled trial (NCT02513160) evaluated efficacy and safety of BDP BAI in persistent asthmatic patients ≥12 years. After a placebo-run-in period, patients were randomized to BDP BAI (320 mcg/day, 640 mcg/day), BDP metered dose inhaler (MDI) 320 mcg/day or placebo. Patient-reported outcomes included: change from baseline in Asthma Control Questionnaire-6 (ACQ-6) and Asthma Quality of Life Questionnaire with Standardized Activities score (AQLQ[S]) at week 6 and treatment endpoint and change from baseline in Asthma Control Test (ACT) at week 6 and treatment endpoint. Adverse events were monitored.
RESULTS: The study evaluated 425 patients. Change from baseline in ACQ-6 scores were demonstrated in the BAI 320 mcg/day (least square (LS) mean: -0.98), BAI 640 mcg/day (-1.04) and MDI (-1.18) groups versus placebo (-0.42), p<0.001. Greater improvement in total mean AQLQ(S) scores occurred with active treatments (LS mean BAI 320 mcg/day: 0.62, BAI 640 mcg/day: 0.80, MDI 320 mcg/day: 0.84 vs placebo: 0.22; p<0.006). Greater proportion of patients achieved clinically significant changes in AQLQ(S) (minimum importance difference ≥0.5 in patients ≥18 years) with active treatments versus placebo. Greater changes in ACT scores were demonstrated with BDP BAI (LS mean 320 mcg/day: 3.4, 640 mcg/day: 3.9) and MDI 320 mcg/day (4.2) versus placebo (1.4) at week 6, p<0.001. No new safety signals.
CONCLUSIONS: Treatment with BDP BAI significantly improved patient-reported outcomes in asthmatic patients versus placebo.