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Obstructive Lung Diseases: Airways 4 |

Trial in Progress: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Trial to Evaluate the Safety and Tolerability of a Nebulized Long-Acting Muscarinic Antagonist (Revefenacin) in Study Participants With COPD

Luis DeLaCruz, MD; Srikanth Pendyala, MD; Chris Barnes, PhD; Edmund Moran, PhD; Brett Haumann, MD; Gregory Feldman
Author and Funding Information

Greenville Pharmaceutical Research Inc., Greenville, SC


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


Chest. 2016;150(4_S):866A. doi:10.1016/j.chest.2016.08.966
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SESSION TITLE: Airways 4

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 persistent and localized bronchodilation with limited systemic side effects. A 28-day study in participants with COPD demonstrated that the optimal benefit-to-risk ratio for revefenacin occurs at once-daily doses of 88 µg and 175 µg. To establish the long-term safety for this dose range, a 52-week phase 3 safety study in participants with COPD is in progress. The trial methodology and select characteristics of participants enrolled to-date are presented here.

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