P250Effects Of 12 Weeks Of Once-daily Tiotropium And Olodaterol Fixed-dose Combination On Exercise Endurance In Patients With Copd

BackgroundBoth tiotropium (T) and olodaterol (O) monotherapies improve exercise endurance in patients with chronic obstructive pulmonary disease (COPD).ObjectiveTo 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.MethodsTORRACTO (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 mu g or 2.5/5 mu g) or placebo once daily via Respimat registered Soft Mist(TM) 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.Results404 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 mu g 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 mu g, 234 mL; T+O 2.5/5 mu g, 207 mL; nominal p < 0.0001). No safety concerns were identified.ConclusionsT+O 5/5 mu g improved endurance time during cycle ergometry versus placebo.[Figure]