Improvements in Lung Function with Nebulized Revefenacin in the Treatment of Patients with Moderate to Very Severe COPD: Results from Two Replicate Phase III Clinical Trials.

Autor: Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills., Feldman G; South Carolina Pharmaceutical Research, Spartanburg., Pudi KK; Sherman Clinical Research, Sherman, Texas., Barnes CN; Theravance Biopharma US, Inc., South San Francisco, California., Moran EJ; Theravance Biopharma US, Inc., South San Francisco, California., Haumann B; Theravance Biopharma US, Inc., South San Francisco, California., Pendyala S; Theravance Biopharma US, Inc., South San Francisco, California., Crater G; Theravance Biopharma US, Inc., South San Francisco, California.
Jazyk: angličtina
Zdroj: Chronic obstructive pulmonary diseases (Miami, Fla.) [Chronic Obstr Pulm Dis] 2019 Apr 09; Vol. 6 (2), pp. 154-165. Date of Electronic Publication: 2019 Apr 09.
DOI: 10.15326/jcopdf.6.2.2018.0152
Abstrakt: Background: Revefenacin, a novel, lung-selective, long-acting muscarinic antagonist, has been developed for nebulized therapy for chronic obstructive pulmonary disease (COPD). We present the results of replicate Phase III efficacy and safety studies of revefenacin in patients with moderate to very severe COPD.
Methods: In 2 double-blind, parallel-group studies, (Study 0126 and Study 0127), patients ≥ 40 years old were randomized to revefenacin 88 μg, revefenacin 175 μg or placebo administered once daily by standard jet nebulizer for 12 weeks. The primary endpoint was 24-hour trough forced expiratory volume in 1 second (FEV 1 ) on day 85. Secondary efficacy endpoints included overall treatment effect (OTE) on trough FEV 1 and peak FEV 1 (0-2 hours after first dose). Safety assessments included treatment-emergent adverse events.
Results: At day 85, revefenacin 88 µg and 175 µg improved trough FEV 1 versus placebo in Study 0126 (by 79 mL [ p =0.0003] and 146 mL [ p <0.0001]) and Study 0127 (by 160 mL and 147 mL; both p <0.0001). Compared with placebo, pooled data of revefenacin 88 µg and 175 µg increased OTE trough FEV 1 by 115 mL and 142 mL (both p <0.001) and increased peak FEV 1 by 127 mL and 129 mL (both p <0.0001). Revefenacin 175 µg demonstrated greater improvements in FEV 1 in concomitant long-acting beta2-agonist patients and in more severe patients than revefenacin 88 µg. Adverse events were minor.
Conclusion: Revefenacin, administered once daily for 12 weeks to patients with moderate to very severe COPD, demonstrated clinically significant improvements in trough FEV 1 and OTE FEV 1 . Revefenacin was generally well tolerated with no major safety concerns.
Competing Interests: GTF has received grants, served on advisory boards, received consulting fees and/or received speaking fees from AstraZeneca, Boehringer Ingelheim, Circassia, Forest, GlaxoSmithKline, Innoviva, Meda, Mylan, Novartis, Pearl Therapeutics, Sanofi, Sunovion, Theravance Biopharma and Verona. GF and KKP have nothing to declare. CNB, EJM, BH, SP and GC are employees of Theravance Biopharma US, Inc. Mylan Inc., (Canonsburg, Pennsylvania) and Theravance Biopharma US, Inc., (South San Francisco, California) funded medical writing support.
(JCOPDF © 2019.)
Databáze: MEDLINE
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