Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma

Status:	Archived
Conditions:	Asthma
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	September 2010
End Date:	June 2011

Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Four 6-Week Period Cross-Over Study to Evaluate Adding GSK2190915, Montelukast or Placebo Tablets or Salmeterol Inhalation Powder to Fluticasone Propionate Inhalation Powder in Uncontrolled Asthmatic Subjects > or = 12 Years of Age.

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.

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Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma

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Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Four 6-Week Period Cross-Over Study to Evaluate Adding GSK2190915, Montelukast or Placebo Tablets or Salmeterol Inhalation Powder to Fluticasone Propionate Inhalation Powder in Uncontrolled Asthmatic Subjects > or = 12 Years of Age.

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