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P250 Effects Of 12 Weeks Of Once-daily Tiotropium And Olodaterol Fixed-dose Combination On Exercise Endurance In Patients With Copd
  1. F Maltais1,
  2. JB Gáldiz Iturri2,
  3. A Kirsten3,
  4. D Singh4,
  5. A Hamilton5,
  6. K Tetzlaff6,
  7. Y Zhao7,
  8. R Casaburi8
  1. 1Research Center, Institut Universitaire de Cardiologie Et de Pneumologie de Québec, Université Laval, Québec, Canada
  2. 2BioCruces Health Research Institute, Barakaldo, Spain
  3. 3Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany
  4. 4Medicines Evaluation Unit, University of Manchester, Manchester, UK
  5. 5Boehringer Ingelheim, Burlington, Ontario, Canada
  6. 6Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim, Germany
  7. 7Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA
  8. 8Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, Los Angeles, California, USA

Abstract

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.

Conclusions T+O 5/5 µg improved endurance time during cycle ergometry versus placebo.

Abstract P250 Figure 1

Geometric mean cycle ergom.etry endurance time after 6 and 12 weeks

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