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2014 ; 3
(3
): 215-221
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gab.com Text
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English Wikipedia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vilanterol, a
Novel Inhaled Long-Acting ?-Agonist, in Children Aged 5-11 Years with Persistent
Asthma: A Randomized Trial
#MMPMID26097789
Oliver A
; VanBuren S
; Allen A
; Hamilton M
; Tombs L
; Kempsford R
; Qaqundah P
Clin Pharmacol Drug Dev
2014[May]; 3
(3
): 215-221
PMID26097789
show ga
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 ß(2)-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.