PMID- 28280319 OWN - NLM STAT- MEDLINE DCOM- 20171010 LR - 20220408 IS - 1178-2005 (Electronic) IS - 1176-9106 (Print) IS - 1176-9106 (Linking) VI - 12 DP - 2017 TI - Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study. PG - 745-755 LID - 10.2147/COPD.S119032 [doi] AB - INTRODUCTION: Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC)/vilanterol (VI) in patients with moderate COPD who remained symptomatic on tiotropium (TIO). METHODS: In this randomized, blinded, double-dummy, parallel-group study (NCT01899742), patients (N=494) who were prescribed TIO for >/=3 months at screening (forced expiratory volume in 1 s [FEV(1)]: 50%-70% of predicted; modified Medical Research Council [mMRC] score >/=1) and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 microg or TIO 18 microg for 12 weeks. Efficacy assessments included trough FEV(1) at Day 85 (primary end point), 0-3 h serial FEV(1), rescue medication use, Transition Dyspnea Index (TDI), St George's Respiratory Questionnaire (SGRQ), and COPD Assessment Test (CAT). Safety evaluations included adverse events (AEs). RESULTS: Compared with TIO, UMEC/VI produced greater improvements in trough FEV(1) (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval CI: 45-131]; P<0.001) and FEV(1) after 5 min on Day 1 (50 mL [95% CI: 27-72]; P<0.001). Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: -0.1 puffs/d [95% CI: -0.2-0.0]; P/=1 unit) with UMEC/VI (63%) versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21-2.64]; P