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 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.
- © 2014 ERS