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.

Keywords:

• Chronic obstructive pulmonary disease
• Japanese
• Long acting muscarinic antagonist
• Safety
• Umeclidinium

Declaration of funding

This study (Clinicaltrials.gov identifier: NCT01702363) was funded by GlaxoSmithKline.

Declaration of financial/other relationships

E.Y. has disclosed that he participated in the study as the investigator and his hospital had received research grants from GlaxoSmithKline. Y.T. has disclosed that he participated in the study as the subinvestigator and the site where he conducted the study had received research grants from GlaxoSmithKline. They have received no direct payment for writing or publishing the manuscript. T.S., K.H., and K.M. have disclosed that they are currently employees of GlaxoSmithKline.

 CMRO peer reviewer 1 has disclosed that she has served as an advisory board member, has been reimbursed for speaker honoraria and has received fees as a consultant for AstraZeneca/Almirall, Chiesi, Guidotti/Malesci, Novartis, Mundipharma, GSK, Sole24 Ore and Artsana. CMRO peer reviewers 2, 3, 4 and 5 have no relevant financial or other relationships to disclose.

Acknowledgments

The authors would like to thank all patients, investigators, and site staff members who participated in the study.

Previous presentation: These data were presented at the 55th annual meeting of the Japanese Respiratory Society, Tokyo, Japan, 17–19 April 2015.

Notes

*Ellipta is trademark of the GlaxoSmithKline group of companies