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Obstructive Lung Diseases: Airways 1 |

Trials in Progress: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Trials of a Nebulized Long-Acting Muscarinic Antagonist (Revefenacin) in Study Participants With Moderate to Very Severe COPD

Krishna Pudi, MD; Srikanth Pendyala, MD; Chris Barnes, PhD; Edmund Moran, PhD; Brett Haumann, MD; Edward Kerwin, MD
Author and Funding Information

Upstate Pharmaceutical Research, Greenville, SC


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;150(4_S):825A. doi:10.1016/j.chest.2016.08.925
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SESSION TITLE: Airways 1

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 26, 2016 at 01:30 PM - 02:30 PM

PURPOSE: Revefenacin (pINN), a novel nebulized long-acting muscarinic antagonist (LAMA) in development for chronic obstructive pulmonary disease (COPD), produces sustained bronchodilation with minimal systemic anticholinergic effects. A 28-day phase 2b study in participants with COPD demonstrated that doses of 88 and 175 µg, administered once daily, produced clinically relevant changes compared with placebo across a range of endpoints. To establish efficacy and safety for this dose range, 2 identical 12-week phase 3 efficacy trials in participants with COPD are in progress; the trial methodology and select characteristics of the participants enrolled to-date are presented here.

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