Effects of aclidinium bromide/formoterol fumarate fixed-dose combination on health status in COPD

Background: Aclidinium/formoterol fixed-dose combination (FDC) is in development for the treatment of COPD. We investigated the effect of the FDC on the health status of patients with moderate-to-severe COPD. Methods: ACLIFORM and AUGMENT were 24-week, randomized, double-blind Phase III studies of twice-daily FDC. Patients received placebo, aclidinium 400 µg, formoterol 12 µg, FDC 400/6 µg, or FDC 400/12 µg. Endpoints were change in St George's Respiratory Questionnaire (SGRQ) total score at Week 24 vs baseline and percentage of patients improving by ≥4 units (the minimum clinically important difference [MCID]).…