Pneumologie 2015; 69 - P77
DOI: 10.1055/s-0035-1544633

Effects of 12 weeks of once-daily tiotropium and olodaterol fixed-dose combination on exercise endurance in patients with COPD

AM Kirsten 1, F Maltais 2, JBG Iturri 3, D Singh 4, A Hamilton 5, K Tetzlaff 6, Y Zhao 7, R Casaburi 8
  • 1Pulmonary Research Institute at Lungclinic Grosshansdorf, Airway Research Center
  • 2Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • 3Respiratory Function, BioCruces Health Research Institute, Barakaldo
  • 4Medicines Evaluation Unit, University of Manchester
  • 5Medical, Boehringer Ingelheim Burlington
  • 6Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG – Ingelheim; Department of Sports Medicine, University of Tübingen
  • 7Biostatistics, Boehringer Ingelheim Pharmaceuticals Inc. Ridgefield
  • 8Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center

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).

Fig. 1: Geometric mean cycle ergometry endurance time after 6 and 12 weeks

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