Last updated: 11/07/2018 04:28:42
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twice Daily and Montelukast 10mg Once Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma while Treated with Short Acting Beta2-agonist.
Trial description: 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 and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline to the end of the 8-Week treatment period in trough forced expiratory volume in one second (FEV1)
Timeframe: Baseline and Week 8
Secondary outcomes:
Mean change from Baseline in daily evening (PM) Peak expiratory flow (PEF) averaged over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in daily trough AM PEF averaged over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in the percentage of symptom-free days averaged over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in the percentage of symptom-free nights averaged over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in the percentage of rescue-free days averaged over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in the percentage of rescue-free nights averaged over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in day-time asthma symptom score over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in night-time asthma symptom score over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Mean change from Baseline in day-time rescue short acting beta2-agonist (SABA) usage over the 8-Week treatment period
Timeframe: Baseline up to Week
Mean change from Baseline in night-time rescue SABA usage over the 8-Week treatment period
Timeframe: Baseline up to Week 8
Number of participants who withdrew due to lack of efficacy during the 8-Week treatment period
Timeframe: Upto 8 Weeks
Interventions:
Drug: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS
Drug: GSK2190915 100mg
Drug: GSK2190915 10mg
Drug: GSK2190915 300mg
Drug: GSK2190915 30mg
Drug: Montelukast 10mg
Drug: Placebo GSK2190915 one tablet
Drug: Placebo montelukast
Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS
Drug: Placebo GSK2190915 two tablets
Enrollment:
700
Observational study model:
Not applicable
Primary completion date:
2011-06-10
Time perspective:
Not applicable
Clinical publications:
Follows R, Snowise N, Ho Shu-yen, Ambery C, Smart K, McQuade B. Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with mild asthma: a randomised dose-ranging study. Respir Res . 2013;14(54):
Medical condition
Asthma
Product
fiboflapon, fluticasone propionate
Collaborators
Not applicable
Study date(s)
June 2010 to October 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
12+ years
Accepts healthy volunteers
No
- Type of Subject: Outpatient
- Age: ≥12 years of age
- History of Life-threatening asthma: Within previous 5 years
- Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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 -
Trial location(s)
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Ocean, New Jersey, United States, 07712
Status
Study Complete
Location
GSK Investigational Site
Bellingham, Washington, United States, 98225
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-06-10
Actual study completion date
2011-06-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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