François Maltais1, Denis O'Donnell2, Juan Bautista Gáldiz Iturri3, Anne-Marie Kirsten4, Dave Singh5, Alan Hamilton6, Kay Tetzlaff7, Yihua Zhao8, Richard Casaburi9. 1. Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, 2725 Chemin Sainte-Foy, Québec, QC G1V 4G5, Canada. 2. Division of Respiratory Medicine, Department of Medicine, Queen's University and Kingston General Hospital, Kingston, Ontario, Canada. 3. BioCruces Health Research Institute, Barakaldo, Spain. 4. Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Grosshansdorf, Germany. 5. Medicines Evaluation Unit, University of Manchester, Manchester, UK. 6. Boehringer Ingelheim, Burlington, Ontario, Canada. 7. Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, and Department of Sports Medicine, University of Tübingen, Tübingen, Germany. 8. Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA. 9. Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
Abstract
BACKGROUND: The TORRACTO® study evaluated the effects of tiotropium/olodaterol versus placebo on endurance time during constant work-rate cycling and constant speed shuttle walking in patients with chronic obstructive pulmonary disease (COPD) after 12 weeks of treatment. METHODS: The effects of once-daily tiotropium/olodaterol (2.5/5 and 5/5 μg) on endurance time during constant work-rate cycle ergometry (CWRCE) after 6 and 12 weeks of treatment were compared with placebo in patients with COPD in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Endurance time during the endurance shuttle walk test (ESWT) after 6 and 12 weeks of treatment was also evaluated in a subset of patients. RESULTS: A total of 404 patients received treatment, with 165 participating in the ESWT substudy. A statistically significant improvement in endurance time during CWRCE was observed after 12 weeks (primary endpoint) with tiotropium/olodaterol 5/5 µg [14% ( p = 0.02)] but not with tiotropium/olodaterol 2.5/5 µg [9% ( p = 0.14)] versus placebo. In the ESWT substudy, a trend to improvement in endurance time during ESWT after 12 weeks (key secondary endpoint) was observed with tiotropium/olodaterol 5/5 µg [21% ( p = 0.055)] and tiotropium/olodaterol 2.5/5 µg [21% ( p = 0.056)] versus placebo. CONCLUSION:Tiotropium/olodaterol 5/5 µg improved endurance time during cycle ergometry versus placebo, with a strong tendency to also improve walking endurance time. [ ClinicalTrials.gov identifier: NCT01525615.].
RCT Entities:
BACKGROUND: The TORRACTO® study evaluated the effects of tiotropium/olodaterol versus placebo on endurance time during constant work-rate cycling and constant speed shuttle walking in patients with chronic obstructive pulmonary disease (COPD) after 12 weeks of treatment. METHODS: The effects of once-daily tiotropium/olodaterol (2.5/5 and 5/5 μg) on endurance time during constant work-rate cycle ergometry (CWRCE) after 6 and 12 weeks of treatment were compared with placebo in patients with COPD in a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Endurance time during the endurance shuttle walk test (ESWT) after 6 and 12 weeks of treatment was also evaluated in a subset of patients. RESULTS: A total of 404 patients received treatment, with 165 participating in the ESWT substudy. A statistically significant improvement in endurance time during CWRCE was observed after 12 weeks (primary endpoint) with tiotropium/olodaterol 5/5 µg [14% ( p = 0.02)] but not with tiotropium/olodaterol 2.5/5 µg [9% ( p = 0.14)] versus placebo. In the ESWT substudy, a trend to improvement in endurance time during ESWT after 12 weeks (key secondary endpoint) was observed with tiotropium/olodaterol 5/5 µg [21% ( p = 0.055)] and tiotropium/olodaterol 2.5/5 µg [21% ( p = 0.056)] versus placebo. CONCLUSION:Tiotropium/olodaterol 5/5 µg improved endurance time during cycle ergometry versus placebo, with a strong tendency to also improve walking endurance time. [ ClinicalTrials.gov identifier: NCT01525615.].
Authors: Luis Puente-Maestu; Paolo Palange; Richard Casaburi; Pierantonio Laveneziana; François Maltais; J Alberto Neder; Denis E O'Donnell; Paolo Onorati; Janos Porszasz; Roberto Rabinovich; Harry B Rossiter; Sally Singh; Thierry Troosters; Susan Ward Journal: Eur Respir J Date: 2016-01-21 Impact factor: 16.671
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Authors: François Maltais; Alan Hamilton; Darcy Marciniuk; Paul Hernandez; Frank C Sciurba; Kai Richter; Steven Kesten; Denis O'Donnell Journal: Chest Date: 2005-09 Impact factor: 9.410
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Authors: Stefan Andreas; Ulrich Bothner; Alberto de la Hoz; Isabel Kloer; Matthias Trampisch; Peter Alter Journal: Int J Chron Obstruct Pulmon Dis Date: 2020-08-10