Revefenacin Area Under the Curve Spirometry in Patients with Moderate to Very Severe COPD.

Several lung function endpoints are utilized in clinical trials of inhaled bronchodilators for chronic obstructive pulmonary disease (COPD). Trough forced expiratory volume in 1 second (FEV This post hoc analysis examined substudy data from 12-week replicate Phase 3 trials (NCT02459080/NCT02512510); patients with moderate to very severe COPD were randomized 1:1 to revefenacin 175 μg or placebo once daily. The substudy patients had FEV Fifty and 47 patients who received revefenacin and placebo underwent 24-hour serial spirometry; most baseline characteristics were aligned between groups. At Day 84 postdose, revefenacin demonstrated sustained improvements in bronchodilation over 24 hours; differences in least squares mean vs placebo were 282, 220, 205, and 212 mL for FEV This substudy analysis supplements previous findings that revefenacin provides sustained bronchodilation over 24 hours. Assessing additional complementary COPD clinical trial endpoints can help clinicians make treatment decisions.

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© 2024 LeMaster et al.

Déclaration de conflit d'intérêts

Corey J. Witenko is a current employee of Theravance Biopharma US, Inc. and owns stock. Melinda K. Lacy is a current employee of Theravance Biopharma US, Inc. and owns stock. Ann W. Olmsted is a paid consultant for Theravance Biopharma US, Inc. and owns stock. Edmund J. Moran is a current employee of Theravance Biopharma US, Inc. and owns stock. In addition, Edmund J. Moran has a patent US11484531 licensed to Viatris. Donald A. Mahler serves on the advisory boards of AstraZeneca, Boehringer Ingelheim, Theravance, Verona, and Viatris and receives royalties from pharmaceutical companies (Elpen Pharmaceutical Company and University of Aberdeen) for the use of baseline dyspnea index/transition dyspnea index. The authors report no other conflicts of interest in this work.