Efficacy of aclidinium/formoterol fixed-dose combination versus salmeterol/fluticasone in COPD
C Vogelmeier, P Paggiaro, J Dorca, P Sliwinski, M Mallet, AM Kirsten, B Seoane, RM Segarra, A Leselbaum, EG Gil · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
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 with COPD. Methods: A randomised, double-blind, Phase IIIb, 24-week study in patients 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). Endpoints were peak FEV1 (primary), Transition Dyspnoea Index (TDI; secondary), CAT, device preference and exacerbati…