PMID- 23332861
OWN - NLM
STAT- MEDLINE
DCOM- 20130923
LR  - 20220408
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 107
IP  - 4
DP  - 2013 Apr
TI  - Fluticasone furoate/vilanterol (100/25; 200/25 mug) improves lung function in 
      COPD: a randomised trial.
PG  - 550-9
LID - S0954-6111(12)00503-3 [pii]
LID - 10.1016/j.rmed.2012.12.016 [doi]
AB  - BACKGROUND: Once-daily combination treatment is an attractive maintenance therapy 
      for COPD. However, the dose of inhaled corticosteroid to use in a once-daily 
      combination is unknown. We compared two strengths of fluticasone furoate (FF) 
      plus vilanterol (VI), the same strengths of the individual components, and 
      placebo. METHODS: Multicentre, randomised, 24-week, double-blind, 
      placebo-controlled, parallel-group study in stable, moderate-to-severe COPD 
      subjects (N = 1224). Subjects were randomised to FF/VI (200/25 mug; 100/25 mug), FF 
      (200 mug; 100 mug), VI 25 mug, or placebo, once daily in the morning. Co-primary 
      efficacy endpoints; 0-4 h weighted mean (wm) FEV(1) on day 168, and change from 
      baseline in trough (23-24 h post-dose) FEV(1) on day 169. The primary safety 
      objective was adverse events (AEs). RESULTS: There was a statistically 
      significant (p < 0.001) increase in wm FEV(1) (209 ml) and trough FEV(1) (131 ml) 
      for FF/VI 200/25 mug vs. placebo; similar changes were seen for FF/VI 100/25 mug 
      vs. placebo. Whereas the difference between FF/VI 200/25 mug and VI 25 mug in 
      change from baseline trough FEV(1) (32 ml) was not statistically significant (p = 
      0.224), the difference between FF/VI 200/25 mug and FF 200 mug for wm FEV(1) (168 
      ml) was significantly different (p < 0.001). VI 25 mug significantly improved wm 
      and trough FEV(1) vs. placebo (185 ml and 100 ml, [corrected] respectively). No 
      increase was seen in on-treatment AEs or serious AEs (SAEs), with active therapy 
      vs. placebo. CONCLUSIONS: FF/VI provides rapid and significant sustained 
      improvement in FEV(1) in subjects with moderate-to-severe COPD, which was not 
      influenced by the dose of FF. These data suggest that FF/VI may offer clinical 
      efficacy in COPD and warrants additional study. GSK study number: HZC112207. 
      ClinicalTrials.gov: NCT01054885.
CI  - Copyright (c) 2013 Elsevier Ltd. All rights reserved.
FAU - Martinez, Fernando J
AU  - Martinez FJ
AD  - University of Michigan, Ann Arbor, MI, USA. fmartine@med.umich.edu
FAU - Boscia, Joseph
AU  - Boscia J
FAU - Feldman, Gregory
AU  - Feldman G
FAU - Scott-Wilson, Catherine
AU  - Scott-Wilson C
FAU - Kilbride, Sally
AU  - Kilbride S
FAU - Fabbri, Leonardo
AU  - Fabbri L
FAU - Crim, Courtney
AU  - Crim C
FAU - Calverley, Peter M A
AU  - Calverley PM
LA  - eng
SI  - ClinicalTrials.gov/NCT01054885
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130116
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 (Chlorobenzenes)
RN  - 0 (Drug Combinations)
RN  - 0 (Glucocorticoids)
RN  - 028LZY775B (vilanterol)
RN  - JS86977WNV (fluticasone furoate)
SB  - IM
EIN - Respir Med. 2013 Dec;107(12):2092-3
MH  - Administration, Inhalation
MH  - Adrenergic beta-2 Receptor Agonists/*administration & dosage/adverse 
      effects/therapeutic use
MH  - Aged
MH  - Androstadienes/*administration & dosage/adverse effects/therapeutic use
MH  - Benzyl Alcohols/*administration & dosage/adverse effects/therapeutic use
MH  - Chlorobenzenes/*administration & dosage/adverse effects/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Drug Therapy, Combination
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- 2013/01/22 06:00
MHDA- 2013/09/24 06:00
CRDT- 2013/01/22 06:00
PHST- 2012/10/26 00:00 [received]
PHST- 2012/12/19 00:00 [revised]
PHST- 2012/12/22 00:00 [accepted]
PHST- 2013/01/22 06:00 [entrez]
PHST- 2013/01/22 06:00 [pubmed]
PHST- 2013/09/24 06:00 [medline]
AID - S0954-6111(12)00503-3 [pii]
AID - 10.1016/j.rmed.2012.12.016 [doi]
PST - ppublish
SO  - Respir Med. 2013 Apr;107(4):550-9. doi: 10.1016/j.rmed.2012.12.016. Epub 2013 Jan 
      16.