Status:
COMPLETED
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
FEMALE
12+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent an...
Eligibility Criteria
Inclusion
- Type of Subject: Outpatient
- Age: ≥12 years of age
- Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
- Asthma Diagnosis: As defined by NIH
- Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio \>0.70
- Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
- Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
- Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
- QTC: QTc(F)\<450msec or QTc(F)\<480 for subjects with Bundle Branch Block
- Liver function: Normal liver function
- Informed Consent
Exclusion
- History of Life-threatening asthma: Within previous 5 years
- Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
- Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
- Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
- OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks
- Immunosuppressive medications: Either using or required during the study
- Liver disease: Current or chronic history
- Concurrent disease/abnormalities: Clinically significant uncontrolled disease
- Investigational medications: Participation in a study or used investigational drug within 30 days
- Drug allergy: β-agonists, corticosteroids, constituents of inhalers
- Milk Protein Allergy: History of severe milk protein allergy
- Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance
- Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs
- History of alcohol or drug abuse: Likely to interfere with the study
- Affiliation with Investigator's Site: Relative or employee
Key Trial Info
Start Date :
June 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2011
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01147744
Start Date
June 28 2010
End Date
October 6 2011
Last Update
October 2 2017
Active Locations (84)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35209
2
GSK Investigational Site
Huntington Beach, California, United States, 92647
3
GSK Investigational Site
Newport Beach, California, United States, 92663
4
GSK Investigational Site
San Diego, California, United States, 92123