Asthma Clinical Trial
Official title:
A Randomized, Double-blind, Repeat Dose, Two Period Crossover Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Inhaled Fluticasone Furoate/Vilanterol 100/25 Micrograms in Children Aged 5 to 11 Years With Persistent Asthma
This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.
This study will investigate the safety and tolerability, pharmacokinetics, and
pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the
novel dry powder inhaler in children aged 5 to 11 years with persistent asthma. Fluticasone
furoate (FF, GW685698) is a novel once daily inhaled corticosteroid (ICS) and vilanterol
(VI, GW642444) is an inhaled once daily long-acting beta2 agonist (LABA). FF/VI is a novel
ICS/LABA combination with once-daily dosing being developed for the treatment of asthma in
adults, adolescents, and children of 5 years and above.
This study will be a randomized, double-blind, repeat dose, two period crossover study, with
FF as the control. During each of two treatment periods subjects will receive either FF/VI
100/25 micrograms (mcg) or FF 100 mcg daily on 14 consecutive mornings via the novel dry
powder inhaler. Approximately 26 subjects will be recruited into this study, with a target
of 20 completed subjects. Safety, tolerability, pharmacokinetics and glucose , potassium and
cortisol levels will be investigated.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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