Background Both tiotropium (T) and olodaterol (O) monotherapies improve exercise endurance in patients with chronic obstructive pulmonary disease (COPD).
Objective To evaluate the effects of T+O fixed-dose combination on exercise endurance in patients with Global initiative for chronic Obstructive Lung Disease (GOLD) 2–3 COPD after 12 weeks.
Methods TORRACTO (NCT01525615) was a 12-week, double-blind, parallel-group, placebo-controlled, Phase III study. Patients with GOLD 2–3 COPD received T+O (5/5 µg or 2.5/5 µg) or placebo once daily via Respimat® Soft Mist™ inhaler. Primary end point was endurance time during constant work-rate cycle ergometry to symptom limitation after 12 weeks. Endurance time during endurance shuttle walking to symptom limitation after 12 weeks was also assessed in a subset of 165 patients. Other end points included pre-exercise inspiratory capacity.
Results 404 patients (269 men) were randomised (full analysis set n = 385). Mean post-bronchodilator forced expiratory volume in 1 second was 1.66 L (58.6% predicted). Endurance time during cycle ergometry was significantly increased by 14% with T+O 5/5 µg versus placebo at 12 weeks. Increases in endurance time during endurance shuttle walking were observed for both T+O doses versus placebo at 12 weeks (21% increase, nominal p = 0.06 for each dose). Both T+O doses increased pre-exercise inspiratory capacity versus placebo at 12 weeks (T+O 5/5 µg, 234 mL; T+O 2.5/5 µg, 207 mL; nominal p < 0.0001). No safety concerns were identified.
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