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P254 Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat® Improves Outcomes Versus Mono-components In Copd In Two 1-year Studies
  1. R Buhl1,
  2. E Derom2,
  3. G Ferguson3,
  4. E Pizzichini4,
  5. J Reid5,
  6. H Watz6,
  7. L Grönke7,
  8. A Hamilton8,
  9. K Tetzlaff7,
  10. L Korducki9,
  11. H Huisman10,
  12. S Waitere-Wijker10,
  13. F Maltais11
  1. 1Pulmonary Department, Mainz University Hospital,, Mainz, Germany
  2. 2Ghent University Hospital, Ghent, Belgium
  3. 3Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan, USA
  4. 4NUPAIVA (Asthma Research Centre), Universidade Federal de Santa Catarina, Santa Catarina, Brazil
  5. 5Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
  6. 6Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany
  7. 7Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim, Germany
  8. 8Boehringer Ingelheim, Burlington, Ontario, Canada
  9. 9Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA
  10. 10Boehringer Ingelheim B. V., Alkmaar, The Netherlands
  11. 11Centre de Recherche, Institut Universitaire de Cardiologie Et de Pneumologie de Québec, Québec, Canada

Abstract

Introduction Tiotropium (T), a once-daily long-acting muscarinic antagonist, is a well-established first-line maintenance treatment in chronic obstructive pulmonary disease (COPD); olodaterol (O) is a once-daily long-acting β2-agonist that has recently gained approval in several countries. Two Phase III replicate pivotal studies assessed the efficacy and safety of fixed-dose combinations of T and O (T+O) delivered via Respimat® Soft Mist™ inhaler in patients with GOLD 2–4 COPD.

Methods Two 52-week, double-blind, parallel-group studies randomised 5162 patients to O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg or T+O 5/5 µg. Primary efficacy end points were trough forced expiratory volume in 1 second (FEV1) response (ie change from baseline), FEV1 area under the curve from 0–3 h and St George’s Respiratory Questionnaire (SGRQ) total score after 24 weeks. Pooled data from the two studies are presented here; lung function from the individual studies will subsequently be provided.

Results All treatments resulted in clinically relevant improvements in lung function, with significant increases with both T+O doses over the individual components (p1 responses were 0.055 L (O 5 µg), 0.073 L (T 2.5 µg), 0.080 L (T 5 µg), 0.118 L (T+O 2.5/5 µg) and 0.140 L (T+O 5/5 µg). SGRQ total scores improved by 5.1 (O 5 µg), 5.7 (T 2.5 µg), 5.6 (T 5 µg), 6.2 (T+O 2.5/5 µg) and 6.8 points (T+O 5/5 µg); differences between T+O 5/5 µg and O 5 µg and T 5 µg were statistically significant (p

Conclusions T+O 5/5 µg significantly improved lung function and provided symptomatic benefit over O 5 µg and T 5 µg.

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