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.
COPD
anti-cholinergic
bronchodilator
imidafenacin
lung function
Journal
International journal of chronic obstructive pulmonary disease
ISSN: 1178-2005
Titre abrégé: Int J Chron Obstruct Pulmon Dis
Pays: New Zealand
ID NLM: 101273481
Informations de publication
Date de publication:
2019
2019
Historique:
received:
12
07
2019
accepted:
05
09
2019
entrez:
2
10
2019
pubmed:
2
10
2019
medline:
17
4
2020
Statut:
epublish
Résumé
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. 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 (FEV Maximum change in FEV 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. JapicCTI-121760 (Japan Pharmaceutical Information Center - Clinical Trials Information [JapicCTI]; http://www.clinicaltrials.jp/user/cteSearch_e.jsp).
Sections du résumé
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 (FEV
Results
Maximum change in FEV
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).
Identifiants
pubmed: 31571853
doi: 10.2147/COPD.S223002
pii: 223002
pmc: PMC6757323
doi:
Substances chimiques
Imidazoles
0
Muscarinic Antagonists
0
imidafenacin
XJR8Y07LJO
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2175-2184Informations de copyright
© 2019 Machida et al.
Déclaration de conflit d'intérêts
Dr. Kinoshita received honoraria from GlaxoSmithKline K.K., Daiichi Sankyo Co. Ltd., Novartis Pharma K.K., Takeda Pharmaceutical Co. Ltd., and Astellas Pharma Inc. Dr. Tsuda received honoraria from Novartis Pharma K.K., Pfizer Japan Inc., and Nippon Boehringer Ingelheim Co. Ltd. Mr. Kawashima and Dr. Suna are full-time employees of Ono Pharmaceutical Co. Ltd., Japan. Dr. Inoue received research grants from Asahi Kasei Corporation, Astellas Pharma Inc., Nippon Boehringer Ingelheim Co. Ltd., Chugai Pharmaceutical Co. Ltd., Sumitomo Dainippon Pharma Co. Ltd., Eisai Co. Ltd., MSD K.K., Nippon Kayaku Co. Ltd., Shionogi & Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., and Teijin Pharma Ltd.; gave lectures and acted on advisory committees for Asahi Kasei Corporation, Astellas Pharma Inc., AstraZeneca K.K., Nippon Boehringer Ingelheim Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., GlaxoSmithKline K.K., Eli Lilly Japan K.K., Kyorin Pharmaceutical Co. Ltd., MSD K.K., Meiji Seika Pharma Co. Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Shionogi & Co. Ltd., Taisho Pharmaceutical Co. Ltd., and Teijin Pharma Ltd. The authors report no other conflicts of interest in this work.
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