Effect of the once-daily long-acting bronchodilator combination umeclidinium/vilanterol (UMEC/VI) and bronchodilator monotherapy on dyspnoea as measured by the transitional dyspnoea index (TDI) in COPD

Rationale: Long-acting bronchodilators are commonly used for dyspnoea relief in COPD. Objective: To evaluate the effect of a fixed-dose combination of the long-acting bronchodilators UMEC and VI (UMEC/VI) and long-acting bronchodilator monotherapy on dyspnoea in COPD. Methods: An analysis was conducted using pooled TDI data from two 24-week, randomised, parallel-group Phase III studies (DB2113360, DB2113374; N=1692) that evaluated once-daily UMEC/VI (125/25; 62.5/25 mcg), UMEC 125 mcg, VI 25 mcg and tiotropium (TIO) 18 mcg. TDI scores were obtained at Days 28, 84, and 168. Results: Clinically-meaningful least-squares (LS) mean TDI scores of ≥1 unit were observed for all treatment groups at the majority of visits. There were no differences between the UMEC/VI doses vs. TIO for TDI score at Day 168 (p≥0.05). Non-inferential treatment differences favouring both doses of UMEC/VI over TIO were observed at Days 28 and 84 (0.5–0.6 units; p Conclusions: Once-daily combination of UMEC/VI provides an additional treatment option to long-acting bronchodilator monotherapy for dyspnoea management in COPD. Funded by GlaxoSmithKline: DB2116844; DB2113360, NCT01316900; DB2113374, NCT01316913.