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: To determine the 24-hour lung-function profile of olodaterol QD in patients with GOLD 2-4 COPD.
METHODS: In two replicate, randomized, double-blind, placebo-controlled, four-way crossover studies, patients with post-bronchodilator FEV1 <80% predicted normal and FEV1/FVC <70% received olodaterol (5 or 10 µg) QD (via Respimat®), formoterol (12 µg) BID (via Aerolizer®), or placebo (1: NCT00931385; 2: NCT00932646) with usual-care background COPD maintenance therapy. Co-primary end points were FEV1 AUC0-12 and AUC12-24 responses after 6 weeks. Secondary end points included FEV1 AUC0-24 and trough FEV1 responses.
RESULTS: Significant improvements versus placebo in FEV1 AUC0-12 and AUC12-24 responses after 6 weeks were reported for olodaterol 5 µg, 10 µg, and formoterol (FEV1 AUC0-12: 0.148, 0.148, 0.141 L [Study 1] and 0.172, 0.174, 0.158 L [Study 2]; FEV1 AUC12-24: 0.109, 0.127, 0.172 L [Study 1] and 0.118, 0.120, 0.155 L [Study 2], respectively; p<0.0001). For both olodaterol doses, FEV1 increased to near-maximal within 30 minutes following morning dose and improvements were sustained over the 24-hour post-dose period. For formoterol BID, FEV1 increased within 30 minutes following morning dose and was sustained over 12 hours; the evening dose caused another increase, which was sustained for a further 12 hours. Over 24 hours, the FEV1 profiles of olodaterol 5 µg, 10 µg, and formoterol were comparable (FEV1 AUC0-24: 0.128, 0.137, 0.156 L [Study 1] and 0.145, 0.147, 0.156 L [Study 2], respectively; p<0.0001 versus placebo). Significant improvements versus placebo in trough FEV1 responses were observed with both olodaterol doses, which were comparable to formoterol: 0.106, 0.113, 0.133 L (Study 1) and 0.97, 0.103, 0.80 L (Study 2), respectively; p≤0.002.
CONCLUSIONS: Olodaterol and formoterol provided significant improvements in co-primary end points compared to placebo. Mean FEV1 over 24 hours for olodaterol 5 and 10 µg QD was comparable to formoterol BID.
CLINICAL IMPLICATIONS: Together with data from its wider Phase III program, these studies provide evidence for the 24-hour bronchodilator efficacy of olodaterol QD in COPD patients. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion
DISCLOSURE: Jonathan A Bernstein: Grant monies (from industry related sources): Bernstein Clinical Research P1, UC UCP Immunology P1 for BI research studies, Other: Travel expenses from BI for attendance at meetings Alan Hamilton: Employee: Boehringer Ingelheim Chad Nivens: Employee: Boehringer Ingelheim Craig LaForce: Grant monies (from industry related sources): North Carolina Research received grants, Other: North Carolina Research received any travel support or expenses received from companies within industry, Consultant fee, speaker bureau, advisory committee, etc.: Craig LaForce has personally received fees from companies within industry in return for consultancy work The following authors have nothing to disclose: Gregory Feldman
Submitted to regulatory authority for marketing approval