Long-term (52 weeks) safety and tolerability of umeclidinium in Japanese patients with chronic obstructive pulmonary disease

Current Medical Research and Opinion
Eiji YamagataYuji Tohda

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. Seriou...Continue Reading

Associated Clinical Trials

References

Feb 23, 2007·The New England Journal of Medicine·Peter M A CalverleyUNKNOWN TORCH investigators
Apr 3, 2007·American Journal of Respiratory and Critical Care Medicine·Pierre ErnstSamy Suissa
Oct 24, 2008·Respiratory Medicine·David M ManninoVictor A Kiri
Oct 3, 2012·Respiratory Physiology & Neurobiology·Marc DecramerGlenn Crater
Jun 5, 2013·Biomedical Papers of the Medical Faculty of the University Palacký, Olomouc, Czechoslovakia·Vladimir KoblizekUNKNOWN Czech Pneumological and Phthisiological Society
Aug 21, 2013·The European Respiratory Journal·Roopa TrivediAlison Church
May 24, 2014·International Journal of Chronic Obstructive Pulmonary Disease·Rachael L DiSantostefanoDavid B Rubin

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Citations

Jan 21, 2016·Current Medical Research and Opinion·Andrea S Melani, Piersante Sestini
Jun 21, 2017·The Cochrane Database of Systematic Reviews·Han NiSoe Moe

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