Conditions: Asthma
Keywords: Fluticasone Furoate Vilanterol Adults GSK573719 Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 421
Healthy volunteers: no

Brief summary:
Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.

Detailed description:

Arms:
arm 1: 100mcg, inhaled arm 2: 100/25mcg inhaled arm 3: 100/15.6-250mcg inhaled

Interventions: intervention 1: FF/GSK573719 intervention 2: FF/GSK573719 intervention 3: FF/GSK573719 intervention 4: FF/GSK573719 intervention 5: FF/GSK573719 intervention 6: FF intervention 7: FF/VI
Intervention descriptions: intervention 1: 100/15.6 intervention 2: 100/31.25 intervention 3: 100/62.5 intervention 4: 100/125 intervention 5: 100/250 intervention 6: 100 intervention 7: 100/25

Protocol document: