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 FREE TO VIEW

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 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.

METHODS: In this partial-blind, parallel-group study (NCT02518139), randomized participants (1:1:1) will receive blinded 88 µg or 175 µg revefenacin administered once daily by inhalation using a standard jet nebulizer or open-label tiotropium administered once daily via Handihaler®. The study objective is to define the long-term safety and tolerability of revefenacin over 52 weeks of treatment, including frequency of adverse events and exacerbations. Trough forced expiratory volume in 1 second (FEV1), use of rescue medication, and patient-reported outcomes will also be reported as exploratory assessments. Participants are allowed to receive concomitant inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) combination therapy with no restrictions, resulting in the following comparisons: revefenacin vs tiotropium and ICS/LABA/revefenacin vs ICS/LABA/tiotropium. The anticipated readout for this study is 3Q2017.

RESULTS: As of March 18, 2016, 749 of 1050 participants have been enrolled (mean age, 64 years; 58% male; 46% current smokers). These participants have moderate-to-very severe COPD (post-ipratropium % predicted FEV1 median [range]: 54.7 [18.0-80.0]% and baseline FEV1 median [range]: 1.27 [0.46-3.50] L), with 37% classified as GOLD category D. Approximately 43% of participants are receiving concomitant therapy with ICS/LABA (92% bid ICS/LABA and 8% qd ICS/LABA). Diabetes, pulmonary hypertension, ischemic heart disease, and gastroesophageal reflux disease are key comorbidities in this patient population.

CONCLUSIONS: In this ongoing phase 3 trial, the safety and tolerability of revefenacin (in conjunction with ICS/LABA therapy) is being evaluated in participants with moderate-to-very severe COPD over a dosing period of 52 weeks.

CLINICAL IMPLICATIONS: Nebulized once-daily revefenacin, a novel LAMA in development for the treatment of COPD, may be an important future treatment option, subject to the results from the phase 3 clinical program that includes this 12-month safety study.

DISCLOSURE: Srikanth Pendyala: Employee: Employee of Theravance Biopharma US, Inc Chris Barnes: Employee: Employee of Theravance Biopharma US, Inc Edmund Moran: Employee: Employee of Theravance Biopharma US, Inc Brett Haumann: Employee: Employee of Theravance Biopharma UK, Ltd The following authors have nothing to disclose: Luis DeLaCruz,, Gregory Feldman

The presentation will discuss a clinical trial for revefenacin, a new drug entity currently under investigation for the treatment of patients with chronic obstructive pulmonary disease (COPD).




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