Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
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.
Timeline
- Start
- 2010-09
- Primary completion
- 2011-10
- Completion
- 2011-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FIBOFLAPON | Small molecule | 100 mg | — |
| Subject | FIBOFLAPON | Small molecule | 300 mg | — |
| Comparator | Montelukast | Other / unclassified | 10 mg | — |
| Background | Fluticasone propionate | Other / unclassified | 100 ug | Inhaled |
| Comparator | Salmeterol | Other / unclassified | 50 ug | Inhaled |