Abstract
BACKGROUND: In two 24-week studies (ACLIFORM [S1], AUGMENT [S2]) investigating two fixed-dose combinations (FDCs) of aclidinium bromide/formoterol fumarate in COPD patients, both FDCs improved lung function vs placebo (PBO) and monotherapy components.
AIM: To examine respiratory symptoms in COPD patients participating in trials S1 and S2.
METHODS: Patients were randomized to twice-daily aclidinium/formoterol 400µg/12µg (FDC12), 400µg/6µg (FDC6), aclidinium 400µg (ACL), formoterol 12µg (FOR), or PBO. Respiratory symptoms were evaluated by the Transition Dyspnea Index (TDI) focal score, change from baseline in EXACT-Respiratory Symptoms (E-RS) total score, and rescue medication use.
RESULTS: Compared with PBO, both FDCs significantly improved TDI focal scores above the minimum clinically important difference (MCID) of 1 unit at week 24 (Table) and at all other time points; both FDCs also showed numerically greater improvements vs monotherapies (ITT populations: S1, N=1726; S2, N=1668). The MCID was achieved by more FDC-treated patients than either placebo or monotherapies. Both FDCs significantly improved E-RS score vs PBO and monotherapies. Compared with PBO, both FDCs significantly reduced average daily rescue medication use over 24 weeks.
CONCLUSIONS: In moderate to severe COPD patients, FDCs of aclidinium/formoterol improved respiratory symptoms compared with placebo and monotherapies over 6 months.
- © 2014 ERS