PMID- 26782971
OWN - NLM
STAT- MEDLINE
DCOM- 20170912
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 32
IP  - 5
DP  - 2016 May
TI  - Long-term (52 weeks) safety and tolerability of umeclidinium in Japanese patients 
      with chronic obstructive pulmonary disease.
PG  - 967-73
LID - 10.1185/03007995.2016.1140029 [doi]
AB  - Objective Umeclidinium bromide (UMEC) 62.5 mug 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 mug 
      in Japanese patients with COPD. Methods This was a 52 week, multicenter, 
      open-label study to evaluate the safety and tolerability of UMEC 125 mug 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 mug, 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 mug was well tolerated over 52 weeks of treatment in Japanese 
      patients with COPD.
FAU - Yamagata, Eiji
AU  - Yamagata E
AD  - a Yamagata Clinic , Oita , Japan ;
FAU - Soutome, Toru
AU  - Soutome T
AD  - b Biomedical Data Sciences Department , GSK , Tokyo , Japan ;
FAU - Hashimoto, Kenichi
AU  - Hashimoto K
AD  - c Respiratory Medicines Development, GSK , Tokyo , Japan ;
FAU - Mihara, Kazuko
AU  - Mihara K
AD  - c Respiratory Medicines Development, GSK , Tokyo , Japan ;
FAU - Tohda, Yuji
AU  - Tohda Y
AD  - d Department of Respiratory Medicine and Allergology , Kinki University , Osaka , 
      Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01702363
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160218
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (GSK573719)
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Quinuclidines)
SB  - IM
MH  - Administration, Inhalation
MH  - Aged
MH  - Drug Administration Schedule
MH  - Dry Powder Inhalers
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/*therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Quinuclidines/*therapeutic use
OTO - NOTNLM
OT  - Chronic obstructive pulmonary disease
OT  - Japanese
OT  - Long acting muscarinic antagonist
OT  - Safety
OT  - Umeclidinium
EDAT- 2016/01/20 06:00
MHDA- 2017/09/13 06:00
CRDT- 2016/01/20 06:00
PHST- 2016/01/20 06:00 [entrez]
PHST- 2016/01/20 06:00 [pubmed]
PHST- 2017/09/13 06:00 [medline]
AID - 10.1185/03007995.2016.1140029 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2016 May;32(5):967-73. doi: 10.1185/03007995.2016.1140029. 
      Epub 2016 Feb 18.