PMID- 22520084
OWN - NLM
STAT- MEDLINE
DCOM- 20120906
LR  - 20121115
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 106
IP  - 8
DP  - 2012 Aug
TI  - Efficacy and optimal dosing interval of the long-acting beta(2) agonist, 
      vilanterol, in persistent asthma: a randomised trial.
PG  - 1110-5
LID - 10.1016/j.rmed.2012.03.007 [doi]
AB  - BACKGROUND: Vilanterol (VI) is a novel once-daily long-acting beta(2) agonist with 
      inherent 24-h activity. The aim of this study was to evaluate the efficacy of 
      three once-daily doses and one twice-daily dose of VI used concurrently with ICS 
      in adult patients (>/=18 years) with persistent asthma. Safety was also assessed. 
      METHODS: Multicentre, randomised, double-blind, placebo-controlled, five-period 
      crossover study consisting of 7-day treatment periods separated by 7-day wash-out 
      periods. Seventy-five patients, maintained on ICS, received VI 6.25, 12.5 and 25 
      mcg once-daily (evening), VI 6.25 mcg twice-daily (morning/evening), and placebo. 
      The primary endpoint was trough forced expiratory volume in 1 s (FEV(1)) (mean of 
      23 h and 24 h post evening dose) on Day 7; secondary endpoint was weighted mean 
      24-h serial FEV(1) on Day 7. RESULTS: All VI groups demonstrated statistically 
      significant increases in trough FEV(1) versus placebo (p < 0.001). There was a 
      statistically significant increase in weighted mean 24-h FEV(1) for each VI group 
      versus placebo (p < 0.001). The effects of once-daily VI on trough FEV(1) and 
      weighted mean 24-h FEV(1) were dose dependent. The incidence of adverse events 
      (AEs) was low in each VI treatment group and was not dose dependent (5-9%; 
      placebo = 18%); no drug-related AEs or serious AEs were reported. CONCLUSION: 
      Once-daily treatment with VI was well tolerated and associated with improvements 
      in lung function. The VI 6.25 mcg twice-daily dose showed the greatest change in 
      trough FEV(1), however, similar changes in weighted mean 24-h FEV(1) with VI 12.5 
      mcg once-daily were observed. Although our study was not powered to demonstrate 
      non-inferiority of once- versus twice-daily dosing of VI, the data suggest no 
      advantage over a 24-h period of twice-daily over once-daily dosing for the same 
      total daily dose. ClinicalTrials.gov: NCT00980200.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Sterling, Richard
AU  - Sterling R
AD  - Carolina Research, Respiratory Medicine, Orangeburg, SC 29118-2040, USA. 
      sterlingent531@yahoo.com
FAU - Lim, Jessica
AU  - Lim J
FAU - Frith, Lucy
AU  - Frith L
FAU - Snowise, Neil G
AU  - Snowise NG
FAU - Jacques, Loretta
AU  - Jacques L
FAU - Haumann, Brett
AU  - Haumann B
LA  - eng
SI  - ClinicalTrials.gov/NCT00980200
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120419
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Benzyl Alcohols)
RN  - 0 (Chlorobenzenes)
RN  - 0 (Glucocorticoids)
RN  - 028LZY775B (vilanterol)
SB  - IM
MH  - Adrenergic beta-2 Receptor Agonists/*administration & dosage/adverse 
      effects/therapeutic use
MH  - Adult
MH  - Asthma/*drug therapy/physiopathology
MH  - Benzyl Alcohols/*administration & dosage/adverse effects/therapeutic use
MH  - Chlorobenzenes/*administration & dosage/adverse effects/therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Glucocorticoids/therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2012/04/24 06:00
MHDA- 2012/09/07 06:00
CRDT- 2012/04/24 06:00
PHST- 2011/12/15 00:00 [received]
PHST- 2012/03/05 00:00 [revised]
PHST- 2012/03/12 00:00 [accepted]
PHST- 2012/04/24 06:00 [entrez]
PHST- 2012/04/24 06:00 [pubmed]
PHST- 2012/09/07 06:00 [medline]
AID - S0954-6111(12)00117-5 [pii]
AID - 10.1016/j.rmed.2012.03.007 [doi]
PST - ppublish
SO  - Respir Med. 2012 Aug;106(8):1110-5. doi: 10.1016/j.rmed.2012.03.007. Epub 2012 
      Apr 19.