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

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 mu g in children aged 5-11 years. Twenty-eight children with persistent asthma received a single inhaled dose of vilanterol 25 mu g or placebo via the ELLIPTA (TM) 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 mu g and 6 (23%) with placebo. No serious or drug-related AEs were reported; 3 subjects experienced upper respiratory tract infection (URTI) with vilanterol 25 mu g versus none with placebo. Similar pharmacokinetic profiles of vilanterol 25 mu g 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 mu g compared with placebo treatment. Vilanterol was well-tolerated and no long-acting beta(2)-agonist (LABA)-mediated AEs were observed. The pharmacokinetic profile of vilanterol 25 mu g suggests exposure is similar regardless of age or gender in a pediatric population aged 5-11 years.