Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
Condition: Asthma
MeSH terms: Asthma
Intervention: FP 100; GSK2190915 100; GSK2190915 300; montelukast; placebo; FP/SAL 100/50
Intervention description: FP 100mcg BID; GSK2190915 100mg QD (AM); GSK2190915 300mg QD (AM); montelukast 10mg QD (PM); placebo BID; FP/SAL 100/50mcg BID
Intervention MeSH terms: Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 162.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: asthma; GSK2190915

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 12 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

          -  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 100mcg 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