%0 Journal Article %A J.F. Donohue %A D. Singh %A C. Munzu %A S. Kilbride %A A. Church %T Evaluating lung function response to umeclidinium/vilanterol (UMEC/VI) 62.5/25mcg, UMEC 62.5mcg and VI 25mcg in COPD patients %D 2014 %J European Respiratory Journal %P P291 %V 44 %N Suppl 58 %X Background: UMEC (a LAMA) is in development as monotherapy and in combination with VI (a LABA) for COPD. Data from two similar studies are presented.Objective: To determine if UMEC/VI provides additional benefit in COPD patients (pts) responsive (≥12% and ≥200mL increase in FEV1 from baseline) to UMEC or VI alone.Methods: In both 12 week randomised, double-blind, 3-way complete block, cross-over studies, COPD pts with FEV1 ≤70% pred. received UMEC 62.5mcg, VI 25mcg and UMEC/VI 62.5/25mcg once daily via ELLIPTA™ DPI during three 14-day treatment periods (with 10–14 day washout). Primary endpoint: weighted mean FEV1 over 0–6h post-dose on Day 14 of each treatment period. Safety assessments included AEs, vital signs and COPD exacerbations.Results: ITT: N=207; N=182. Primary endpoint: see table.Incidence of on-treatment AEs was similar across treatments in studies '132 (12–18%) and '133 (16–18%). There were no unexpected effects on vital signs. Exacerbations (on/post-treatment): 3 in study '132 (1 per treatment group); 6 in study '133 (3 UMEC, 2 VI, 1 UMEC/VI). Deaths: 1 in '133 (UMEC group; not drug related).Conclusions: UMEC/VI 62.5/25mcg statistically significantly improved lung function in COPD pts identified as responders or non-responders to UMEC 62.5mcg and/or VI 25mcg monotherapy. No new safety concerns were identified.Funding: GSK (DB2116132 [NCT02014480];DB2116133 [NCT01716520]). %U