Tiotropium plus olodaterol shows clinically meaningful improvements in quality of life

Background: Tiotropium + olodaterol improves lung function and symptoms compared to mono-therapies in chronic obstructive pulmonary disease (COPD). The OTEMTO 1 and 2 studies investigated the effects of tiotropium + olodaterol on lung function and health-related quality of life compared to placebo in patients with moderate to severe COPD. Methods: In these two replicate, double-blind, parallel-group, placebo-controlled trials, patients were randomised to receive tiotropium + olodaterol 5/5 mu g, 2.5/5 mu g, tiotropium 5 mu g or placebo for 12 weeks, via the Respimat (R) inhaler. Primary end points were St George's Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC(0-3)) response and trough FEV1 response. Results: In OTEMTO 1 and 2, tiotropium + olodaterol 5/5 mu g improved SGRQ total score by 4.89 (95% confidence interval [CI] -6.90, -2.88) and 4.56 (95% CI -6.50, -2.63) units versus placebo (both p < 0.0001), and 2.49 (95% CI -4.47, -0.51; p < 0.05) and 1.72 (95% CI -3.63, 0.19) units versus tiotropium 5 mu g. Tiotropium + olodaterol 2.5/5 mu g significantly improved SGRQ score compared to placebo. Both doses significantly improved FEV1 AUC(0-3) response compared to placebo and tiotropium 5 mu g. Tiotropium + olodaterol 5/5 and 2.5/5 mu g also significantly improved trough FEV1 response compared to placebo (both studies) and separated from tiotropium 5 mu g in OTEMTO 2. Adverse-event incidence was similar between treatment groups. Conclusion: Tiotropium + olodaterol improved lung function and quality of life compared to placebo and tiotropium 5 mu g. (C) 2015 The Authors. Published by Elsevier Ltd.