Safety of aclidinium bromide/formoterol fumarate fixed-dose combination in COPD: pooled analyses of three Phase III studies

Background: Two 24-week Phase III studies (ACLIFORM and AUGMENT) and a 28-week AUGMENT extension study assessed the efficacy and safety of two twice-daily aclidinium/formoterol fixed-dose combinations (FDC) in patients with moderate-to-severe COPD. Aim: To assess adverse events (AEs) in a pooled analysis of the three Phase III studies. Methods: The studies were randomized, double-blind, placebo- and active-controlled. Patients received placebo, formoterol 12 µg, aclidinium 400 µg, FDC 400/6 µg or FDC 400/12 µg twice daily. Patients who continued into the extension study from AUGMENT remained on the same treatmen…