5 years ago

Tiotropium + olodaterol shows clinically meaningful improvements in quality of life

Tiotropium + olodaterol improves lung function and symptoms compared to monotherapies 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 μg, 2.5/5 μg, tiotropium 5 μg or placebo for 12 weeks, via the Respimat® 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 (AUC0–3) response and trough FEV1 response. Results In OTEMTO 1 and 2, tiotropium + olodaterol 5/5 μg 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 μg. Tiotropium + olodaterol 2.5/5 μg significantly improved SGRQ score compared to placebo. Both doses significantly improved FEV1 AUC0–3 response compared to placebo and tiotropium 5 μg. Tiotropium + olodaterol 5/5 and 2.5/5 μg also significantly improved trough FEV1 response compared to placebo (both studies) and separated from tiotropium 5 μg 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 μg. Trial registration ClinicalTrials.gov: NCT01964352 and NCT02006732.

Publisher URL: www.sciencedirect.com/science

DOI: S0954611115300342

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