Effects of a combination of vilanterol and umeclidinium on exercise endurance in subjects with COPD: Two randomised clinical trials

Aims Two studies tested the effect of umeclidinium (UMEC)/vilanterol (VI) on exercise tolerance, lung function and safety in COPD. Methods Moderate to severe COPD subjects with hyperinflation were randomised into multi-centred (DB2114417 and DB2114418), double blind,incomplete block,crossover studies for 12-weeks. Subjects received two of the following, placebo (pbo), UMEC/VI (125/25mcg or 62.5/25mcg),UMEC(125mcg or 62.5mcg) or VI(25mcg). Co-primary outcomes were the change in exercise endurance time during the endurance shuttle walk test and trough FEV 1 at week 12 versus pbo. Safety assessments were carried out. Results 349 (study417) and 308 (study418) subjects randomised.Similar improvements in exercise duration from baseline at week 12 for both doses of UMEC/VI were observed. Significant changes in exercise duration vs pbo in 418 but not 417 were observed, a large pbo effect was seen in 417.Both doses improved lung function at week 12. Adverse events were 417,418 pbo 27%,39%,UMEC/VI 125/25, 23%,44% and 62.5/25, 32%,41%. Conclusions UMEC/VI improves exercise endurance from baseline, provides effective bronchodilation and appears safe over 12 weeks. GSK funded.NCT01328444,NCT01323660.