Effect of aclidinium bromide/formoterol fumarate fixed-dose combination on exacerbations in moderate-to-severe COPD: Pooled analysis of two studies

Background: Aclidinium/formoterol 400/12 µg fixed-dose combination (FDC) is in development for the treatment of COPD. We present pooled COPD exacerbation data from two Phase III studies. Methods: ACLIFORM and AUGMENT were 24-week, randomized, double-blind Phase III studies of aclidinium/formoterol FDC in patients with moderate-to-severe COPD. Treatment arms were FDC 400/6 µg, FDC 400/12 µg, aclidinium 400 µg, formoterol 12 µg or placebo (all twice-daily via Genuair®/Pressair® inhaler). Prior exacerbation was not an inclusion criterion. Healthcare resource utilization (HCRU; symptom increase on ≥2 consecutive day…