Conditions: Asthma
Keywords: asthma GSK2190915
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 162
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.

The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.

Detailed description:

Arms:
arm 1: FP 100mcg BID plus GSK2190915 100mg QD (AM) arm 2: FP 100mcg BID plus GSK2190915 300mg QD (AM) arm 3: FP 100mcg BID plus montelukast 10mg QD (PM) arm 4: FP 100mcg BID plus placebo BID arm 5: FP/SAL 100/50mcg BID plus placebo BID

Interventions: intervention 1: FP 100 intervention 2: GSK2190915 100 intervention 3: GSK2190915 300 intervention 4: montelukast intervention 5: placebo intervention 6: FP/SAL 100/50
Intervention descriptions: intervention 1: FP 100mcg BID intervention 2: GSK2190915 100mg QD (AM) intervention 3: GSK2190915 300mg QD (AM) intervention 4: montelukast 10mg QD (PM) intervention 5: placebo BID intervention 6: FP/SAL 100/50mcg BID

Protocol document: