Conditions: Asthma
Keywords: Efficacy Asthma Safety Fluticasone Propionate FLAP Beta-agonists GSK2190915 Montelukast Placebo FLAIR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 700
Healthy volunteers: no

Brief summary:
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.

Detailed description:

Arms:
arm 1: GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS arm 2: GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS arm 3: GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS arm 4: GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS arm 5: Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening arm 6: Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS arm 7: Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS

Interventions: intervention 1: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS intervention 2: GSK2190915 100mg intervention 3: GSK2190915 10mg intervention 4: GSK2190915 300mg intervention 5: GSK2190915 30mg intervention 6: Montelukast 10mg intervention 7: Placebo GSK2190915 one tablet intervention 8: Placebo montelukast intervention 9: Placebo fluticasone propionate via ACCUHALER/DISKUS intervention 10: Placebo GSK2190915 two tablets
Intervention descriptions: intervention 1: Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS intervention 2: GSK2190915 100mg (1 x 100mg) once daily in the morning intervention 3: GSK2190915 10mg (1 x 10mg) once daily in the morning intervention 4: GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning intervention 5: GSK2190915 30mg (1 x 30mg) once daily in the morning intervention 6: Montelukast 10mg (1 x 10mg capsule) once daily in the evening intervention 7: Placebo tablet, one tablet once daily in the morning intervention 8: Placebo capsule once daily in the evening intervention 9: Inhaled placebo twice daily via ACCUHALER/DISKUS intervention 10: Placebo tablet, two tablets once daily in the morning

Protocol document: