Pneumologie 2015; 69 - P171
DOI: 10.1055/s-0035-1544637

Once-daily tiotropium and olodaterol fixed-dose combination via the Respimat improves outcomes vs mono-components in COPD in two 1-year studies

R Buhl 1, E Derom 2, G Ferguson 3, F Maltais 4, E Pizzichini 5, J Reid 6, H Watz 7, L Groenke 8, A Hamilton 9, K Tetzlaff 8, L Korducki 10, H Huisman 11, S Waitere-Wijker 11, E Bateman 12
  • 1Pulmonary Department, Mainz University Hospital
  • 2Respiratory Division, Ghent University Hospital
  • 3Pulmonology Department, Pulmonary Research Institute of Southeast Michigan
  • 4Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • 5NUPAIVA (Asthma Research Centre), Universidade Federal de Santa Catarina
  • 6Dunedin School of Medicine, University of Otago
  • 7Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North
  • 8Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG
  • 9Medical, Boehringer Ingelheim Burlington
  • 10Biostatistics, Boehringer Ingelheim Pharmaceuticals Inc. Ridgefield
  • 11Medical, Boehringer Ingelheim B.V. Alkmaar
  • 12Division of Pulmonology, University of Cape Town Lung Institute

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 ß2-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 Stage 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 FEV1 response (ie change from baseline), FEV1 area under the curve from 0 – 3 hours and 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 (p < 0.001 for each study). Trough FEV1 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 < 0.05 in both cases). All treatments were well tolerated.

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

Funding: Boehringer Ingelheim.

Presented at ERS congress meeting 2014