Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease

• Published in: Therapeutic advances in respiratory disease 2018-01, Vol.12, p.1753465818755091-1753465818755091
• Main Authors: Maltais, François, O’Donnell, Denis, Gáldiz Iturri, Juan Bautista, Kirsten, Anne-Marie, Singh, Dave, Hamilton, Alan, Tetzlaff, Kay, Zhao, Yihua, Casaburi, Richard
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists - administration & dosage; Adrenergic beta-2 Receptor Agonists - adverse effects; Adult; Aged; Benzoxazines - administration & dosage; Benzoxazines - adverse effects; Bicycling; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Cholinergic Antagonists - administration & dosage; Cholinergic Antagonists - adverse effects; Chronic obstructive pulmonary disease; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Ergometry; Exercise Tolerance - drug effects; Female; Forced Expiratory Volume; Humans; Lung - drug effects; Lung - physiopathology; Male; Middle Aged; Original Research; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Recovery of Function; Time Factors; Tiotropium Bromide - administration & dosage; Tiotropium Bromide - adverse effects; Treatment Outcome; Vital Capacity; Walking
• ISSN: 1753-4666; 1753-4658; 1753-4666
• DOI: 10.1177/1753465818755091

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.]