PMID- 23867808
OWN - NLM
STAT- MEDLINE
DCOM- 20140513
LR  - 20220408
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 107
IP  - 10
DP  - 2013 Oct
TI  - Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the 
      ENLIGHTEN study.
PG  - 1558-67
LID - S0954-6111(13)00210-2 [pii]
LID - 10.1016/j.rmed.2013.05.016 [doi]
AB  - BACKGROUND: QVA149 is an inhaled, once-daily fixed-dose dual bronchodilator 
      combination of the long-acting beta2-agonist indacaterol and long-acting muscarinic 
      antagonist glycopyrronium (NVA237) for the treatment of chronic obstructive 
      pulmonary disease (COPD). We investigated the safety and efficacy of QVA149 over 
      52 weeks. METHODS: This 52-week, multicenter, double-blind, parallel-group, 
      placebo-controlled study randomized (2:1) patients with moderate-to-severe COPD 
      to once-daily QVA149 (110 mug indacaterol/50 mug glycopyrronium) or placebo 
      delivered via the Breezhaler device. Primary endpoint was safety and tolerability 
      for treatment-emergent adverse events (AEs). Secondary endpoints included safety 
      based on vital signs, electrocardiograms (ECGs), laboratory evaluations, and 
      pre-dose forced expiratory volume in 1 s (FEV1). RESULTS: Of 339 patients 
      randomized, QVA149 [n = 226], placebo [n = 113]; 76.9% male, mean age: 62.6 
      years, post-bronchodilator FEV1: 57.4% predicted, 83.5% completed study. A 
      smaller percentage of patients discontinued in the QVA149 group (14.2%) compared 
      with placebo (21.2%). Overall incidence of AEs was similar in the QVA149 (57.8%) 
      and placebo (56.6%) groups, with most AEs being mild to moderate in severity. The 
      numerical differences in some AEs observed could be at least in part explained by 
      differences in baseline patient characteristics. No clinically relevant 
      differences were observed between treatment groups for vital signs or ECG 
      parameters. The five deaths reported were unrelated to study medication (QVA149, 
      n = 4 [1.8%]; placebo, n = 1 [0.9%]). QVA149 demonstrated rapid and clinically 
      meaningful bronchodilation sustained over 52 weeks versus placebo. CONCLUSION: 
      QVA149 demonstrated a good safety and tolerability profile, providing rapid and 
      sustained bronchodilation over 52 weeks in patients with moderate-to-severe COPD. 
      ClinicalTrials.gov identifier: NCT01120717.
CI  - Copyright (c) 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Dahl, Ronald
AU  - Dahl R
AD  - Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic 
      address: ronadahl@rm.dk.
FAU - Chapman, Kenneth R
AU  - Chapman KR
FAU - Rudolf, Michael
AU  - Rudolf M
FAU - Mehta, Rajendra
AU  - Mehta R
FAU - Kho, Pearl
AU  - Kho P
FAU - Alagappan, Vijay K T
AU  - Alagappan VK
FAU - Chen, Hungta
AU  - Chen H
FAU - Banerji, Donald
AU  - Banerji D
LA  - eng
SI  - ClinicalTrials.gov/NCT01120717
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130716
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Indans)
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Quinolones)
RN  - 0 (indacaterol-glycopyrronium combination)
RN  - V92SO9WP2I (Glycopyrrolate)
SB  - IM
MH  - Adrenergic beta-2 Receptor Agonists/adverse effects/therapeutic use
MH  - Aged
MH  - Bronchodilator Agents/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Glycopyrrolate/adverse effects/*analogs & derivatives/therapeutic use
MH  - Humans
MH  - Indans/adverse effects/*therapeutic use
MH  - Male
MH  - Medication Adherence/statistics & numerical data
MH  - Middle Aged
MH  - Muscarinic Antagonists/adverse effects/therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/physiopathology
MH  - Quinolones/adverse effects/*therapeutic use
MH  - Spirometry
MH  - Treatment Outcome
MH  - Vital Capacity/drug effects
OTO - NOTNLM
OT  - Bronchodilators
OT  - Chronic obstructive pulmonary disease
OT  - Lung function
OT  - QVA149
OT  - Safety
EDAT- 2013/07/23 06:00
MHDA- 2014/05/14 06:00
CRDT- 2013/07/23 06:00
PHST- 2013/02/18 00:00 [received]
PHST- 2013/05/28 00:00 [revised]
PHST- 2013/05/29 00:00 [accepted]
PHST- 2013/07/23 06:00 [entrez]
PHST- 2013/07/23 06:00 [pubmed]
PHST- 2014/05/14 06:00 [medline]
AID - S0954-6111(13)00210-2 [pii]
AID - 10.1016/j.rmed.2013.05.016 [doi]
PST - ppublish
SO  - Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 
      Jul 16.