title: Long-term (52 weeks) safety and tolerability of umeclidinium in Japanese patients with chronic obstructive pulmonary disease.
abstract: Objective Umeclidinium bromide (UMEC) 62.5 μg is a long-acting muscarinic antagonist (LAMA) that is administered once daily via inhalation for chronic obstructive pulmonary disease (COPD) treatment. The objective of this study was to evaluate the safety and tolerability of long-term treatment with UMEC 125 μg in Japanese patients with COPD. Methods This was a 52 week, multicenter, open-label study to evaluate the safety and tolerability of UMEC 125 μg once daily delivered via a novel dry powder inhaler (nDPI) in Japanese patients with COPD. The primary endpoint was the incidence and severity of all adverse events (AEs) throughout the 52 week treatment period. Clinical trial registration number ClinicalTrials.gov identifier is NCT01702363. Results A total of 153 patients were enrolled in the study. Of these, 131 patients started treatment with UMEC 125 μg, and 111 patients (85%) completed the study. AEs did not differ greatly in incidence over the various time periods (Weeks 0 to 12, 13 to 24, 25 to 36, and 37 to 52 of treatment) and did not increase with continued treatment. The incidence of drug-related AEs associated with the pharmacological effects of LAMAs (including constipation, blurred vision, and thirst) was low. Serious adverse events (SAEs) during the treatment period were reported in 17 patients (13%). SAEs reported in more than one patient were COPD exacerbation and pneumonia (3 patients each, 2%). One SAE of angina pectoris was considered to be drug related. No fatalities were reported during this study. Conclusions No new AEs were identified beyond those attributable to the pharmacological effects of LAMAs. UMEC 125 μg was well tolerated over 52 weeks of treatment in Japanese patients with COPD.
authors.affiliation: a Yamagata Clinic , Oita , Japan ;
authors.forename: Eiji
authors.initials: E
authors.lastname: Yamagata
authors.affiliation: b Biomedical Data Sciences Department , GSK , Tokyo , Japan ;
authors.forename: Toru
authors.initials: T
authors.lastname: Soutome
authors.affiliation: c Respiratory Medicines Development, GSK , Tokyo , Japan ;
authors.forename: Kenichi
authors.initials: K
authors.lastname: Hashimoto
authors.affiliation: c Respiratory Medicines Development, GSK , Tokyo , Japan ;
authors.forename: Kazuko
authors.initials: K
authors.lastname: Mihara
authors.affiliation: d Department of Respiratory Medicine and Allergology , Kinki University , Osaka , Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Tohda
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D004334:Drug Administration Schedule; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011812:Quinuclidines / Q000627:therapeutic use*
chemical_list: C573971:GSK573719; D018727:Muscarinic Antagonists; D011812:Quinuclidines
keywords: Chronic obstructive pulmonary disease; Japanese; Long acting muscarinic antagonist; Safety; Umeclidinium