Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily

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.

Conditions

• Asthma

Interventions

DRUG

Fluticasone Propionate 100mcg via ACCUHALER/DISKUS

Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS

DRUG

GSK2190915 100mg

GSK2190915 100mg (1 x 100mg) once daily in the morning

DRUG

GSK2190915 10mg

GSK2190915 10mg (1 x 10mg) once daily in the morning

DRUG

GSK2190915 300mg

GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning

DRUG

GSK2190915 30mg

GSK2190915 30mg (1 x 30mg) once daily in the morning

DRUG

Montelukast 10mg

Montelukast 10mg (1 x 10mg capsule) once daily in the evening

DRUG

Placebo GSK2190915 one tablet

Placebo tablet, one tablet once daily in the morning

DRUG

Placebo montelukast

Placebo capsule once daily in the evening

DRUG

Placebo fluticasone propionate via ACCUHALER/DISKUS

Inhaled placebo twice daily via ACCUHALER/DISKUS

DRUG

Placebo GSK2190915 two tablets

Placebo tablet, two tablets once daily in the morning

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-28

Primary Completion

2011-10-06

Completion

2011-10-06

Countries

• United States
• Bulgaria
• Japan
• Poland
• Romania
• Ukraine

Study Locations