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