title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vilanterol, a Novel Inhaled Long-Acting β-Agonist, in Children Aged 5-11 Years with Persistent Asthma: A Randomized Trial.
abstract: 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 µg in children aged 5-11 years. Twenty-eight children with persistent asthma received a single inhaled dose of vilanterol 25 µg 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 µg and 6 (23%) with placebo. No serious or drug-related AEs were reported; 3 subjects experienced upper respiratory tract infection (URTI) with vilanterol 25 µg versus none with placebo. Similar pharmacokinetic profiles of vilanterol 25 µg 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 µg compared with placebo treatment. Vilanterol was well-tolerated and no long-acting ß2-agonist (LABA)-mediated AEs were observed. The pharmacokinetic profile of vilanterol 25 µg suggests exposure is similar regardless of age or gender in a pediatric population aged 5-11 years.
authors.affiliation: GlaxoSmithKline Uxbridge, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Oliver
authors.affiliation: GlaxoSmithKline King of Prussia, PA, USA.
authors.forename: Sandi
authors.initials: S
authors.lastname: VanBuren
authors.affiliation: GlaxoSmithKline Stevenage, UK.
authors.forename: Ann
authors.initials: A
authors.lastname: Allen
authors.affiliation: GlaxoSmithKline Ware, UK.
authors.forename: Melanie
authors.initials: M
authors.lastname: Hamilton
authors.affiliation: Synergy Slough, UK.
authors.forename: Lee
authors.initials: L
authors.lastname: Tombs
authors.affiliation: GlaxoSmithKline Stevenage, UK.
authors.forename: Rodger
authors.initials: R
authors.lastname: Kempsford
authors.affiliation: Pediatric Care Medical Group Huntington Beach, CA, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Qaqundah
keywords: asthma; children; pharmacokinetics and pharmacodynamics; tolerability; vilanterol