Dave Singh1, Gary T Ferguson2, Josef Bolitschek3, Lars Grönke4, Christoph Hallmann4, Nathan Bennett5, Roger Abrahams6, Olaf Schmidt7, Leif Bjermer8. 1. The Medicines Evaluation Unit, Manchester, UK. Electronic address: dsingh@meu.org.uk. 2. Pulmonary Research Institute of Southeast Michigan, Livonia, MI, USA. 3. Krankenhaus der Elisabethinen, Linz, Austria. 4. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. 5. Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA. 6. Morgantown Pulmonary Associates, Morgantown, WV, USA. 7. Lungen- und Bronchialheilkunde, Koblenz, Germany. 8. Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
Abstract
BACKGROUND: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 μgimproved 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.
RCT Entities:
BACKGROUND: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.
Authors: Rüdiger Sauer; Michaela Hänsel; Roland Buhl; Roman A Rubin; Marcel Frey; Thomas Glaab Journal: Int J Chron Obstruct Pulmon Dis Date: 2016-04-27