PMID- 26097789
OWN - NLM
STAT- Publisher
LR  - 20191120
IS  - 2160-763X (Print)
IS  - 2160-7648 (Electronic)
IS  - 2160-763X (Linking)
VI  - 3
IP  - 3
DP  - 2014 May
TI  - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vilanterol, a 
      Novel Inhaled Long-Acting beta-Agonist, in Children Aged 5-11 Years with Persistent 
      Asthma: A Randomized Trial.
PG  - 215-221
AB  - This multi-center, randomized, double-blind, placebo-controlled, two-way 
      crossover study was designed to characterize the safety, tolerability, 
      pharmacokinetic, and pharmacodynamic profile of single and once-daily repeat 
      doses of vilanterol 25 microg in children aged 5-11 years. Twenty-eight children with 
      persistent asthma received a single inhaled dose of vilanterol 25 microg or placebo 
      via the ELLIPTA dry powder inhaler (DPI) on Day 1, followed 7 days later by 
      once-daily treatment for 7 days. Nine (33%) subjects reported adverse events 
      (AEs) with vilanterol 25 microg and 6 (23%) with placebo. No serious or drug-related 
      AEs were reported; 3 subjects experienced upper respiratory tract infection 
      (URTI) with vilanterol 25 microg versus none with placebo. Similar pharmacokinetic 
      profiles of vilanterol 25 microg were observed irrespective of age or gender. No 
      clinically relevant changes in heart rate, Fridericia's correction (QTcF), 
      maximum glucose or minimum potassium parameters were observed during treatment 
      with vilanterol 25 microg compared with placebo treatment. Vilanterol was 
      well-tolerated and no long-acting ss(2)-agonist (LABA)-mediated AEs were observed. 
      The pharmacokinetic profile of vilanterol 25 microg suggests exposure is similar 
      regardless of age or gender in a pediatric population aged 5-11 years.
FAU - Oliver, Amanda
AU  - Oliver A
AD  - GlaxoSmithKline Uxbridge, UK.
FAU - VanBuren, Sandi
AU  - VanBuren S
AD  - GlaxoSmithKline King of Prussia, PA, USA.
FAU - Allen, Ann
AU  - Allen A
AD  - GlaxoSmithKline Stevenage, UK.
FAU - Hamilton, Melanie
AU  - Hamilton M
AD  - GlaxoSmithKline Ware, UK.
FAU - Tombs, Lee
AU  - Tombs L
AD  - Synergy Slough, UK.
FAU - Kempsford, Rodger
AU  - Kempsford R
AD  - GlaxoSmithKline Stevenage, UK.
FAU - Qaqundah, Paul
AU  - Qaqundah P
AD  - Pediatric Care Medical Group Huntington Beach, CA, USA.
LA  - eng
PT  - Journal Article
DEP - 20140206
PL  - United States
TA  - Clin Pharmacol Drug Dev
JT  - Clinical pharmacology in drug development
JID - 101572899
PMC - PMC4467260
OTO - NOTNLM
OT  - asthma
OT  - children
OT  - pharmacokinetics and pharmacodynamics
OT  - tolerability
OT  - vilanterol
EDAT- 2015/06/23 06:00
MHDA- 2015/06/23 06:00
PMCR- 2015/06/15
CRDT- 2015/06/23 06:00
PHST- 2012/12/18 00:00 [received]
PHST- 2013/11/08 00:00 [accepted]
PHST- 2015/06/23 06:00 [entrez]
PHST- 2015/06/23 06:00 [pubmed]
PHST- 2015/06/23 06:00 [medline]
PHST- 2015/06/15 00:00 [pmc-release]
AID - 10.1002/cpdd.92 [doi]
PST - ppublish
SO  - Clin Pharmacol Drug Dev. 2014 May;3(3):215-221. doi: 10.1002/cpdd.92. Epub 2014 
      Feb 6.