Imidafenacin, an orally active muscarinic receptor antagonist, improves pulmonary function in patients with chronic obstructive pulmonary disease: A multicenter, randomized, double-blind, placebo-controlled 3×3 crossover phase II trial

Kentaro Machida, Tomotaka Kawayama, Masaharu Kinoshita, Masakazu Ichinose, Tohru Tsuda, Shohei Takata, Hiroshi Koto, Makoto Yoshida, Yoshinori Ashihara, Masaru Kawashima, Hideaki Suna, Hiromasa Inoue

Research output: Contribution to journalArticle

Abstract

Background: Although long-acting muscarinic receptor antagonists are central to the management of chronic obstructive pulmonary disease (COPD), inhaled medicines may have technical difficulty in some patients and adherence barriers. Methods: A multicenter, randomized, double-blind, placebo-controlled 3×3 crossover Phase II trial was performed to evaluate the efficacy and safety of oral administration of the antimuscarinic agent imidafenacin in patients with COPD. Twenty-seven male COPD patients with % forced expiratory volume in 1 s (FEV1) =30% and <80% predicted were randomized to single oral dose of imidafenacin 0.1 mg, imidafenacin 0.2 mg, or placebo. Results: Maximum change in FEV1 with both doses of imidafenacin significantly improved from baseline to 24 hrs after administration when compared with a placebo. Area under the curve in FEV1 during 24 hrs after administration with 0.2 mg, but not 0.1 mg dose, was significantly improved when compared with a placebo, and the improvement was significantly based on dosedependent manners. Plasma imidafenacin level was positively correlated with change in FEV1. All subjects with both doses of imidafenacin completed without moderate nor severe adverse events. Conclusion: A single oral dose of imidafenacin 0.1 mg or imidafenacin 0.2 mg may contribute to the improvement of pulmonary function with excellent safety and tolerability in patients with COPD. Trial registration: JapicCTI-121760 (Japan Pharmaceutical Information Center - Clinical Trials Information [JapicCTI]; http://www.clinicaltrials.jp/user/cteSearch_e.jsp).

Original languageEnglish
Pages (from-to)2175-2184
Number of pages10
JournalInternational Journal of COPD
Volume14
DOIs
Publication statusPublished - 2019

Keywords

  • Anti-cholinergic
  • Bronchodilator
  • Copd
  • Imidafenacin
  • Lung function

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Health Policy
  • Public Health, Environmental and Occupational Health

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