A randomised, placebo-controlled, Phase II, dose-ranging trial of once-daily treatment with olodaterol, a novel long-acting β2-agonist, for 4 weeks in patients with chronic obstructive pulmonary disease

Summary Background Olodaterol is a novel long-acting β 2 -agonist (LABA) with ≥24-h duration of action in preclinical and clinical studies. Objective This Phase II, multicentre, randomised, double-blind, placebo-controlled, parallel-group, dose-finding study evaluated four doses of once-daily olodaterol over 4 weeks in patients with chronic obstructive pulmonary disease (COPD), based on efficacy, safety and pharmacokinetic parameters. Methods Patients received olodaterol inhalation solution or placebo via Respimat ® Soft Mist™ inhaler once daily for 4 weeks. Pulmonary function testing was performed pre-dose (trough) and up to 3 or 6 h post-dose, depending on visit. Primary end point was change from baseline in trough forced expiratory volume in 1 s (FEV 1 ) after 4 weeks' treatment. Secondary end points included change from baseline in peak FEV 1 and FEV 1 area under the curve from 0 to 6 h. Results 405 patients with COPD were randomised and assigned to treatment. Mean baseline post-bronchodilator FEV 1 was 1.50 L (54% predicted). All olodaterol doses provided statistically significant increases in trough FEV 1 compared to placebo (2 μg: 0.061 L [ p  = 0.0233]; 5 μg: 0.097 L [ p  = 0.0003]; 10 μg: 0.123 L [ p p Conclusion Once-daily olodaterol demonstrated 24-h bronchodilator efficacy, confirming its potential as a once-daily LABA for the management of COPD. Trial registration: ClinicalTrials.gov: NCT00452400 .