Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD
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 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 or 2.5/5 µg) once daily via Respimat Soft Mist inhaler, or placebo. Primary end point was endurance time (ET) during constant work-rate cycle ergometry to symptom limitation after 12 weeks. ET during endurance shuttle walking (ESW) to symptom limitation after 12 weeks was also assessed in a subset of 165 patients. Other end points included pre-exercise inspiratory capacity (IC).
Results: 404 patients (269 men) were randomised (full analysis set n= 385). Mean post-bronchodilator FEV1 was 1.66 L (58.6% predicted).
ET during cycle ergometry was significantly increased with T+O 5/5 µg vs placebo at 12 weeks. Increases in ET during ESW were observed for both T+O doses vs placebo at 12 weeks (21% increase, nominal p = 0.06 for each dose). Both T+O doses increased pre-exercise IC vs placebo (nominal p < 0.0005). No safety concerns were identified.
Conclusions: T+O 5/5 µg improved ET during cycle ergometry vs placebo.
Funding: Boehringer Ingelheim.
Presented at ERS congress 2014