Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects > or = 18 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 to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Montelukast

Criteria

Inclusion Criteria:

• Age: 18 years of age or older

• Non-, former or current smokers with a documented smoking history of ≤ 10 pack years

• Asthma diagnosis as defined by the National Institutes of Health

• Best FEV1 of 50% to <80% of the predicted normal value

• For current and former smokers, a post-albuterol FEV1/FVC ratio of >0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)

• ≥ 12% and ≥200mL reversibility of FEV1

• Must have been using FP/SAL 250/50mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.

• Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol

• Must be able and willing to give written informed consent to take part in the study.

• Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.

Exclusion criteria:

• History of life-threatening asthma

• Recent asthma exacerbation

• Concurrent respiratory disease

• Recent respiratory infection

• Liver disease

• Other concurrent diseases/abnormalities

• Oral candidiasis

• Drug allergy

• Milk protein allergy

• Immunosuppressive Medications

• Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1

• OATP1B1 substrates within 4 weeks of Visit 1

• Cytochrome P450 3A4 (CYP 3A4) Inhibitors

• Cytochrome P450 3A4 (CYP 3A4) Inducers

• Investigational Medications

• Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol

• Affiliation with Investigator's Site