Abstract
Background: The novel long-acting β2-agonist olodaterol (O) and long-acting muscarinic antagonist tiotropium (T) have a duration of action of at least 24 h in clinical studies. Dual administration may provide improved bronchodilation with convenient once-daily dosing.
Objective: To determine the optimum once-daily combination of T+O delivered via the Respimat® inhaler in patients with COPD.
Methods: In a randomised, double-blind, 4-period, incomplete crossover study, patients with post-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥30% and <80% of predicted normal received combinations of T and O, with both agents delivered via separate Respimat® inhalers, as well as O monotherapy, once daily for 4 weeks (NCT 01040403). The primary end point was trough FEV1 response (L) at the end of week 4.
Results: In total, 232 COPD patients (133 male; 99 female) received treatment. FEV1 responses (trough and up to 6 h post-dose) for O 5 and 10 μg monotherapy were similar. For all doses of T, FEV1 responses were significantly increased when added to O 5 and 10 μg. Dose ordering for T when added to O was evident. No safety or tolerability concerns were identified.
Conclusions: Addition of T to O resulted in significant improvements in FEV1 versus O alone. These data support further investigation of T 2.5 and 5 μg combined with O 5 μg in the Phase III T+O clinical trial programme.
- © 2012 ERS
