Conditions: Asthma
Keywords: pediatric ages 5 to 11 years
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: One of two study treatments subjects will receive. Given to allow comparison of FF exposure in combination versus as mono therapy. arm 2: One of two study treatments subjects will receive. FF/VI combined is being tested and compared to fluticasone furoate.

Interventions: intervention 1: Fluticasone Furoate intervention 2: Fluticasone Furoate/Vilanterol
Intervention descriptions: intervention 1: 100mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period. intervention 2: 100/25 mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.

Protocol document: