PMID- 23830094
OWN - NLM
STAT- MEDLINE
DCOM- 20140513
LR  - 20220409
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 107
IP  - 10
DP  - 2013 Oct
TI  - Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD.
PG  - 1538-46
LID - S0954-6111(13)00213-8 [pii]
LID - 10.1016/j.rmed.2013.06.001 [doi]
AB  - STUDY OBJECTIVE: To examine the efficacy and safety of the once-daily, inhaled, 
      long-acting muscarinic antagonist/beta2-agonist combination umeclidinium/vilanterol 
      (UMEC/VI) compared with UMEC and VI monotherapies in patients with chronic 
      obstructive pulmonary disease (COPD). METHODS: In this 24-week, double-blind, 
      placebo-controlled, parallel-group study (ClinicalTrials.gov: NCT01313650) 
      eligible patients were randomised 3:3:3:2 to treatment with UMEC/VI 62.5/25 mcg, 
      UMEC 62.5 mcg, VI 25 mcg or placebo administered once daily via dry powder 
      inhaler (N = 1532; intent-to-treat population). Primary endpoint was trough 
      forced expiratory volume in one second (FEV1) on Day 169 (23-24 h post-dose). 
      Additional lung-function, symptomatic, and health-related quality-of-life 
      endpoints were assessed, including 0-6 h weighted-mean FEV1, rescue salbutamol 
      use, Transition Dyspnoea Index (TDI), Shortness Of Breath With Daily Activity 
      (SOBDA) and St. George's Respiratory Questionnaire (SGRQ) scores. Safety 
      evaluations included adverse events (AEs), vital signs, 12-lead/24-h Holter 
      electrocardiography parameters and clinical laboratory/haematology measurements. 
      RESULTS: All active treatments produced statistically significant improvements in 
      trough FEV1 compared with placebo on Day 169 (0.072-0.167 L, all p < 0.001); 
      increases with UMEC/VI 62.5/25 mcg were significantly greater than monotherapies 
      (0.052-0.095 L, p </= 0.004). Improvements were observed for UMEC/VI 62.5/25 mcg vs 
      placebo for weighted-mean FEV1 on Day 168 (0.242 L, p < 0.001), rescue salbutamol 
      use during Weeks 1-24 (-0.8 puffs/day, p = 0.001), TDI (1.2 units, p < 0.001), 
      SOBDA (-0.17 units, p < 0.001) and SGRQ (-5.51 units, p < 0.001) scores. No 
      clinically-significant changes in vital signs, electrocardiography, or laboratory 
      parameters were observed. CONCLUSION: Once-daily UMEC/VI 62.5/25 mcg was well 
      tolerated and provided clinically-significant improvements in lung function and 
      symptoms in patients with COPD.
CI  - Copyright (c) 2013 Elsevier Ltd. All rights reserved.
FAU - Donohue, J F
AU  - Donohue JF
AD  - Department of Medicine, 111 Mason Farm Road, University of North Carolina College 
      of Medicine, Chapel Hill, NC 27599, USA. Electronic address: 
      james_donohue@med.unc.edu.
FAU - Maleki-Yazdi, M R
AU  - Maleki-Yazdi MR
FAU - Kilbride, S
AU  - Kilbride S
FAU - Mehta, R
AU  - Mehta R
FAU - Kalberg, C
AU  - Kalberg C
FAU - Church, A
AU  - Church A
LA  - eng
SI  - ClinicalTrials.gov/NCT01313650
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130702
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Drug Combinations)
RN  - 0 (GSK573719)
RN  - 0 (Quinuclidines)
RN  - 028LZY775B (vilanterol)
SB  - IM
MH  - Aged
MH  - Benzyl Alcohols/administration & dosage/adverse effects/*therapeutic use
MH  - Bronchodilator Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Chlorobenzenes/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/physiopathology
MH  - Quality of Life
MH  - Quinuclidines/administration & dosage/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Vital Capacity/drug effects
OTO - NOTNLM
OT  - COPD
OT  - Fixed-dose combination
OT  - Long-acting bronchodilator
OT  - Muscarinic antagonist
OT  - Randomised
OT  - beta-agonist
EDAT- 2013/07/09 06:00
MHDA- 2014/05/14 06:00
CRDT- 2013/07/09 06:00
PHST- 2013/03/28 00:00 [received]
PHST- 2013/05/30 00:00 [revised]
PHST- 2013/06/02 00:00 [accepted]
PHST- 2013/07/09 06:00 [entrez]
PHST- 2013/07/09 06:00 [pubmed]
PHST- 2014/05/14 06:00 [medline]
AID - S0954-6111(13)00213-8 [pii]
AID - 10.1016/j.rmed.2013.06.001 [doi]
PST - ppublish
SO  - Respir Med. 2013 Oct;107(10):1538-46. doi: 10.1016/j.rmed.2013.06.001. Epub 2013 
      Jul 2.