PMID- 23352226
OWN - NLM
STAT- MEDLINE
DCOM- 20130923
LR  - 20220408
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 107
IP  - 4
DP  - 2013 Apr
TI  - A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on 
      lung function in COPD.
PG  - 560-9
LID - S0954-6111(12)00501-X [pii]
LID - 10.1016/j.rmed.2012.12.014 [doi]
AB  - BACKGROUND: Fluticasone furoate (FF)/vilanterol (VI) is a novel once-daily 
      inhaled corticosteroid/long-acting beta2-agonist combination therapy for COPD. We 
      aimed to assess the efficacy and safety of two strengths of FF/VI (100/25 mug; 
      50/25 mug) vs. individual components (FF 100 mug, VI 25 mug) and placebo over 24 
      weeks. METHODS: Multicentre, randomised, placebo-controlled, double-blind, 
      parallel-group study of patients (N = 1030) with moderate-to-severe COPD. All 
      medication was administered once daily in the morning. Co-primary efficacy 
      endpoints were: (1) weighted mean (wm) FEV1 (0-4 h post-dose on day 168) to 
      assess acute lung function effects; and (2) trough FEV1 (23-24 h post-dose on day 
      169) to assess long-lasting effects. Symptom-related outcomes were analysed and 
      adverse events (AEs) assessed. RESULTS: Main findings were: (1) the combination 
      of FF/VI at a strength of 100/25 mug significantly (p < 0.001) improved wm FEV1 
      (173 ml) and trough FEV1 (115 ml) vs. placebo. Similar effects were observed with 
      FF/VI 50/25 mug; (2) no significant difference was seen between FF/VI 100/25 mug 
      and VI 25 mug for trough FEV1 (48 ml, p = 0.082), while an effect was observed 
      between FF/VI 100/25 mug and FF 100 mug for wm FEV1 (120 ml, p < 0.001); (3) VI 
      25 mug over 24 weeks improved lung function vs. placebo significantly for wm FEV1 
      (103 ml, p < 0.001) and trough FEV1 (67 ml, p = 0.017); and (4) no safety signal 
      was observed. CONCLUSIONS: In subjects with moderate-to-severe COPD, FF/VI 
      100/25 mug provides rapid and significant sustained bronchodilation at 24 weeks. 
      Lung function is improved to a similar extent with FF/VI 50/25 mug and to a 
      somewhat lesser extent with VI 25 mug. All treatments were well tolerated. GSK 
      study number: HZC112206. ClinicalTrials.gov: NCT01053988.
CI  - Copyright (c) 2013 Elsevier Ltd. All rights reserved.
FAU - Kerwin, Edward M
AU  - Kerwin EM
AD  - Clinical Research Institute of Southern Oregon, 3860 Crater Lake Avenue, Medford, 
      OR 97504, USA. ekerwin@allergyasthmaso.com
FAU - Scott-Wilson, Catherine
AU  - Scott-Wilson C
FAU - Sanford, Lisa
AU  - Sanford L
FAU - Rennard, Stephen
AU  - Rennard S
FAU - Agusti, Alvar
AU  - Agusti A
FAU - Barnes, Neil
AU  - Barnes N
FAU - Crim, Courtney
AU  - Crim C
LA  - eng
SI  - ClinicalTrials.gov/NCT01053988
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130123
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Androstadienes)
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Drug Combinations)
RN  - 0 (Glucocorticoids)
RN  - 028LZY775B (vilanterol)
RN  - JS86977WNV (fluticasone furoate)
SB  - IM
EIN - Respir Med. 2013 Dec;107(12):2094
MH  - Adrenergic beta-2 Receptor Agonists/adverse effects/*therapeutic use
MH  - Aged
MH  - Androstadienes/administration & dosage/adverse effects/*therapeutic use
MH  - Benzyl Alcohols/adverse effects/*therapeutic use
MH  - Bronchodilator Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Chlorobenzenes/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Glucocorticoids/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/physiopathology
MH  - Treatment Outcome
EDAT- 2013/01/29 06:00
MHDA- 2013/09/24 06:00
CRDT- 2013/01/29 06:00
PHST- 2012/10/26 00:00 [received]
PHST- 2012/12/19 00:00 [revised]
PHST- 2012/12/22 00:00 [accepted]
PHST- 2013/01/29 06:00 [entrez]
PHST- 2013/01/29 06:00 [pubmed]
PHST- 2013/09/24 06:00 [medline]
AID - S0954-6111(12)00501-X [pii]
AID - 10.1016/j.rmed.2012.12.014 [doi]
PST - ppublish
SO  - Respir Med. 2013 Apr;107(4):560-9. doi: 10.1016/j.rmed.2012.12.014. Epub 2013 Jan 
      23.