SESSION TITLE: New treatments for COPD
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM
PURPOSE: Olodaterol, a novel once-daily (QD) inhaled LABA, has proven clinical efficacy with regards to lung function (FEV1). This study assessed the effects of olodaterol QD on exercise endurance in COPD patients.
METHODS: In two replicate, randomized, double-blind, placebo-controlled, three-way crossover studies, patients with post-bronchodilator FEV1 <80% predicted value and FEV1/FVC <70% received olodaterol (5 or 10 µg) or placebo QD (via Respimat®) for 6 weeks (Study 1: NCT01040130; Study 2: NCT01040793). Static lung hyperinflation was not required for participation. Patients could continue receiving SAMAs, ICS, and xanthines as background therapy. Primary end point was endurance time (ET) during constant work-rate cycle ergometry to symptom limitation performed at 75% maximal work capacity. Secondary end points were inspiratory capacity (IC) and intensity of breathing discomfort (Borg Category-Ratio Scale) at a standardized exercise time (isotime).
RESULTS: 147 and 154 patients (aged 41-75 years) were included in the analyses of Studies 1 and 2, respectively. After 6 weeks’ treatment with olodaterol 5, 10 µg, or placebo, geometric mean ET was 422, 421, and 370 seconds (Study 1), and 396, 391, and 354 seconds (Study 2), respectively. At Week 6, mean log-transformed ET was 14% and 11% greater with olodaterol 5 µg versus placebo in Studies 1 (p≤0.0003) and 2 (p≤0.002), respectively. Similar improvements were observed with olodaterol 10 µg. Increases versus placebo in mean IC at isotime for olodaterol 5 and 10 µg were significant: 0.182 and 0.174 L (p<0.0001; Study 1) and 0.084 and 0.166 L (p≤0.02; Study 2), respectively. Olodaterol 5 and 10 µg provided statistically significant decreases in breathing discomfort versus placebo at isotime in Study 1 (-0.766 and -0.634; p<0.006), but not Study 2 (-0.336 and -0.066; p<0.8).
CONCLUSIONS: Treatment with olodaterol 5 and 10 µg resulted in statistically significant improvements in exercise ET and IC at isotime versus placebo.
CLINICAL IMPLICATIONS: The bronchodilator efficacy of olodaterol translates into reduced dynamic hyperinflation during exercise, producing improvements in symptom-limited exercise tolerance. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: François Maltais: Consultant fee, speaker bureau, advisory committee, etc.: Astra Zeneca, Boehringer Ingelheim, GlaxoSmithKline, Grant monies (from industry related sources): Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca, Nycomed, Pfizer Anne-Marie Kirsten: Grant monies (from industry related sources): Institution received money for study from Boehringer Ingelheim for which Dr Kirsten was a clinical investigator on Alan Hamilton: Employee: Boehringer Ingelheim Dorothy De Sousa: Employee: Boehringer Ingelheim Fei Wang: Employee: Boehringer Ingelheim Marc Decramer: Fiduciary position (of any organization, association, society, etc, other than ACCP: Institution receives money in return for Board membership - Boehringer-Pfizer, GSK, Nycomed, Altana, Consultant fee, speaker bureau, advisory committee, etc.: Institution receives money in return for consultancy work for Boehringer-Pfizer, Nycomed, Dompé, Novartis and GSK. Also speaker bureau work on Boehringer-Pfizer, Nycomed, Dompé, Novartis and GSK, Grant monies (from industry related sources): Astra Zeneca
Submitted to regulatory authority for marketing approval