Efficacy of aclidinium/formoterol fixed-dose combination versus salmeterol/fluticasone in COPD

Background: Aclidinium bromide/formoterol fumarate fixed-dose combination (FDC) twice daily (BID) is licensed in Europe for COPD treatment. Aim: To evaluate the efficacy of aclidinium/formoterol vs salmeterol/fluticasone propionate FDC (SAL/FLU) in patients (pts) with COPD. Methods: A randomised, double-blind, Phase IIIb, 24-week study in pts with COPD Assessment Test (CAT) score ≥10 compared aclidinium/formoterol 400/12 µg BID via Genuair® with SAL/FLU 50/500 µg BID via Accuhaler® ([NCT01908140][1]). Endpoints were peak FEV1 (primary), Transition Dyspnoea Index (TDI; secondary), CAT, device preference and exacerbations. Non-inferiority of aclidinium/formoterol vs SAL/FLU was tested for peak FEV1 and TDI. Superiority in peak FEV1 was also analysed. Results: 933 pts were randomised: mean age 63.4 years; 65.1% male; mean post-bronchodilator FEV1 1.48 L (53.2% predicted); mean CAT score 18.5. 788 pts (84.5%) completed the study. Aclidinium/formoterol achieved greater peak FEV1 vs SAL/FLU from Day 1 to Week 24 (p<0.0001; Table). Improvements in TDI, CAT and exacerbations were similar in both groups (Table). More pts preferred Genuair (51.9%) than Accuhaler (18.5%, p<0.0001). Conclusion: Superiority in peak FEV1 and non-inferiority in TDI were demonstrated for aclidinium/formoterol FDC vs SAL/FLU in pts with stable COPD. Improvements in quality of life and exacerbations were similar in both groups. More pts preferred Genuair to Accuhaler. ![Figure][2] [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01908140&atom=%2Ferj%2F46%2Fsuppl_59%2FPA2960.atom [2]: pending:yes