Efficacy and safety of olodaterol once daily delivered via Respimat(®) in patients with GOLD 2–4 COPD: results from two replicate 48-week studies

BACKGROUND: Olodaterol is a long-acting β(2)-agonist with a 24-hour bronchodilator profile. Two replicate, randomized, double-blind, placebo-controlled, parallel-group, Phase III trials were performed as part of a comprehensive clinical program to investigate the long-term safety and efficacy of olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving usual-care background therapy. METHODS: Patients received olodaterol 5 μg or 10 μg or placebo once daily for 48 weeks. Coprimary end points were forced expiratory volume in 1 second (FEV(1)) area under the curve from 0 to 3 hours (AUC(0–3)) response (change from baseline), and trough FEV(1) response at 12 weeks. Secondary end points included additional lung function assessments, use of rescue medications, FEV(1) AUC response from 0 to 12 hours, and Patient Global Rating over 48 weeks. RESULTS: Overall, 624 and 642 patients were evaluated in studies 1222.11 and 1222.12, respectively. In both studies, olodaterol 5 μg and 10 μg significantly improved the FEV(1) AUC(0–3) response (P<0.0001) and trough FEV(1) (study 1222.11, P<0.0001; study 1222.12, P<0.05, post hoc) at week 12, with an incidence of adverse events comparable with that of placebo. Secondary end points supported the efficacy of olodaterol. CONCLUSION: These studies demonstrate the long-term efficacy and safety of once-daily olodaterol 5 μg and 10 μg in patients with moderate to very severe COPD continuing with usual-care maintenance therapy.