20 August 2015
Olodaterol is a novel long-acting β 2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.
This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD) olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD).
All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat ® Soft Mist™ inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV 1) after 4 weeks of olodaterol treatment. Secondary end points included trough FEV 1 after 1 week and 2 weeks of treatment, FEV 1 area under the curve from 0 hour to 3 hours (AUC 0–3), peak FEV 1 from 0 hour to 3 hours (peak FEV 1), and corresponding forced vital capacity (FVC) responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.
A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV 1 compared to placebo at Day 29 ( P<0.0001). Mean increases in peak FEV 1 and FEV 1 AUC 0–3 compared to placebo were also significant ( P<0.0001). A clear dose–response relationship was observed across all treatment groups. FVC responses (trough and FVC AUC 0–3) supported FEV 1 outcomes. All doses of olodaterol were well tolerated, and no safety concerns were identified.
QD olodaterol demonstrated 24-hour bronchodilator efficacy and was well tolerated in Japanese patients with COPD.