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

2014-08-27 03:12:48 | BioPortfolio

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 coticosteroid and a leukotriene receptor antagonist.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Asthma

Intervention

GSK2190915 30mg, GSK2190915 300mg, GSK2190915 100mg, GSK2190915 10mg, Montelukast 10mg, Placebo, Fluticasone Propionate 100mcg BD

Location

GSK Investigational Site
San Diego
California
United States
92123

Status

Recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:48-0400

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Medical and Biotech [MESH] Definitions

None available.

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