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

Abstract

Background Aclidinium/formoterol fixed-dose combination (FDC) is in development for the management of COPD. The ACLIFORM and AUGMENT studies assessed the effects of twice-daily FDC on health status in patients with moderate to severe COPD. Method ACLIFORM and AUGMENT were multinational, double-blind, placebo- and active-controlled, parallel-group studies. Patients were randomized to receive placebo, aclidinium 400 µg, formoterol 12 µg, FDC 400/6 µg or FDC 400/12 µg. Change from baseline in SGRQ total score at Week 24 and the percentage of patients achieving or exceeding the MCID (≥4 units) were assessed. Results In total, 1726 (mean age 63.2 years; 67.6% male; moderate COPD 60.1%; mean baseline SGRQ score 46.2) and 1668 (mean age 63.9 years; 53.2% male; moderate COPD 57.0%; mean baseline SGRQ score 46.0) patients were included in the ITT population in ACLIFORM and AUGMENT, respectively. In both studies, both FDC doses improved SGRQ total score by ≥MCID at Week 24 and >50% of patients receiving FDC achieved or exceeded the MCID (Table). In ACLIFORM, improvements in SGRQ total score with FDC did not reach significance versus placebo, possibly due to a very large placebo response (>MCID). Conclusion These studies indicate that aclidinium/formoterol FDC improves health status in patients with moderate to severe COPD, notwithstanding the large placebo effect that may have masked the treatment effect in ACLIFORM. ![Figure][1] [1]: pending:yes