Status:
COMPLETED
Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 inhalati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01248975
Start Date
December 1 2010
End Date
October 1 2011
Last Update
November 25 2016
Active Locations (19)
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1
GSK Investigational Site
Pleven, Bulgaria, 5800
2
GSK Investigational Site
Rousse, Bulgaria, 7000
3
GSK Investigational Site
Varna, Bulgaria, 9010
4
GSK Investigational Site
Bialystok, Poland, 15-084