TY - JOUR T1 - Umeclidinium/vilanterol (UMEC/VI) once daily (OD) vs fluticasone/salmeterol combination (FSC) twice daily (BD) in patients with moderate-to-severe COPD and infrequent COPD exacerbations JF - European Respiratory Journal JO - Eur Respir J VL - 44 IS - Suppl 58 SP - P290 AU - D. Singh AU - S. Worsley AU - C.-Q. Zhu AU - L. Hardaker AU - A. Church Y1 - 2014/09/01 UR - http://erj.ersjournals.com/content/44/Suppl_58/P290.abstract N2 - Background: UMEC (a LAMA) plus VI (a LABA) is a new combination bronchodilator maintenance treatment for COPD. FSC is indicated as a maintenance therapy for COPD.Objective: To compare the efficacy and safety of UMEC/VI inhalation powder with FSC in pts with moderate-to-severe COPD and infrequent COPD exacerbations (none in previous year).Methods: A 12-week, multicentre, double-blind, parallel-group, double-dummy study. Pts (n=716) were randomised 1:1 to UMEC/VI 62.5/25mcg OD (via ELLIPTA™ device) or FSC 500/50µg BD (via DISKUS device™). Endpoints included: LS mean Δ from baseline (BL) in weighted mean (wm) FEV1 over 0–24h post-dose at Day 84 (primary); trough FEV1 at Day 84 (secondary); symptoms. Safety included AEs and vital signs.Results: UMEC/VI statistically significantly improved all lung function measures, including peak, onset and duration of effect vs FSC. Improvements with UMEC/VI vs FSC were 80mL (95%CI: 46,113) for 0–24h wmFEV1 and 90mL (55,125) for trough FEV1 (both p<0.001). Both treatments demonstrated clinically meaningful improvements in dyspnoea (TDI focal score >1 unit) and quality of life (Δ from BL in SGRQ Total score >4 unit decrease) over 12 weeks. AEs (UMEC/VI, FSC): on-treatment (28%,29%); drug-related (2%,4%); on-treatment SAEs (2%,<1%). Vitals signs: little Δ from BL with UMEC/VI or FSC. Deaths: 1 (UMEC/VI group; not drug related).Conclusions: UMEC/VI 62.5/25mcg OD over 12 weeks led to significant, sustained and clinically meaningful improvements in lung function vs FSC 500/50mcg BD in these pts. No new safety findings were reported.Funding: GSK (DB2116134;NCT01822899). ER -