AMPLIFY: efficacy of aclidinium vs tiotropium in COPD

Background: Aclidinium bromide (AB) and tiotropium (TIO) are long-acting anti-muscarinic COPD maintenance therapies. AB has not been compared with TIO beyond 6 weeks (wks). Aim: To compare efficacy and safety of AB vs TIO at 24 wks in symptomatic patients (pts) with COPD. Methods: AMPLIFY (NCT02796677) was a Phase 3, 24-wk, double-blind, active-controlled study. Pts with moderate to very severe COPD and CAT score ≥10 were randomized to twice-daily AB/formoterol fumarate (FF) 400/12 µg, AB 400 µg or FF 12 µg or once-daily TIO 18 µg. The primary non-inferiority endpoint (AB vs TIO; per protocol [PP] population) was change from baseline (Δ) in morning pre-dose (trough) FEV1 at Wk 24 (treatment difference lower 95% confidence interval [CI] > –50 mL). AB/FF data are shown elsewhere. A subset of pts entered a 24-h spirometry sub-study. Results: The intent-to-treat population (AB and TIO arms) included 950 pts (Table). At Wk 24, Δtrough FEV1 for AB vs TIO was within the non-inferiority limit (Δ7 mL [95% CI –21, 35 mL]; PP population [n=842]). Other bronchodilation outcomes were significantly improved for AB vs TIO on Day 1; differences at Wk 24 were not statistically significant (Table). Health-related quality of life (QoL) improvements and treatment-emergent adverse events were similar between groups (Table). Conclusions: In pts with COPD, AB was non-inferior to TIO in improving trough FEV1 and had similar efficacy for other bronchodilation and QoL outcomes at Wk 24.