Asthma
Conditions
Keywords
asthma, GSK2190915
Brief 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.
Interventions
DRUGFP/SAL 250/50mcg BID
FP/SAL 250/50mcg BID
DRUGGSK2190915 200mg QD (AM)
GSK2190915 200mg QD (AM)
DRUGGSK2190915 100mg QD (AM)
GSK2190915 100mg QD (AM)
DRUGMontelukast 10mg QD (PM)
Montelukast 10mg QD (PM)
DRUGPlacebo tablets (2) (AM)
Placebo tablets (2) (AM)
DRUGPlacebo capsule (PM)
Placebo capsule (PM)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 | at the end of the 6 week treatment period. |
Secondary
| Measure | Time frame |
|---|---|
| • Daily PM PEF | averaged over the last 3 weeks of the 6 week treatment period. |
| • Daily (average of AM and PM) | averaged over the last 3 weeks of the 6 week treatment period |
| • Daily asthma symptom score | averaged over the last 3 weeks of the 6 week treatment period. |
| • Daily rescue salbutamol use | averaged over the last 3 weeks of the 6 week treatment period. |
| • Percentage of symptom-free days | during the last 3 weeks of the 6 week treatment period. |
| • Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF | averaged over the last 3 weeks of the 6 week treatment period. |
| • Percentage of rescue-free days | during the last 3 weeks of the 6 week treatment period. |
| • Percentage of rescue-free nights | during the last 3 weeks of the 6 week treatment period. |
| • Percentage of nights without awakenings due to asthma | during the last 3 weeks of the 6 week treatment period. |
| • Proportion of subjects withdrawn due to lack of efficacy | during the last 3 weeks of the 6 week treatment period. |
| • Percentage of symptom-free nights | during the last 3 weeks of the 6 week treatment period. |
Countries
Bulgaria, Poland, Ukraine
Outcome results
None listed