Last updated: 11/07/2018 07:31:56
Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 years of age
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Trough (AM pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) at the end of the 6-week treatment period
Timeframe: End of Week 6
Secondary outcomes:
Daily trough (morning pre-dose and pre-rescue bronchodilator) morning peak expiratory flow (PEF) averaged over the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Daily evening PEF averaged over the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Daily (average of morning and evening) PEF averaged over the last 3 weeks of the 6 -week treatment period between GSK2190915 and montelukast groups
Timeframe: Week 4 to Week 6
Daily asthma symptom score averaged over the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Daily rescue short-acting beta2-agonist (SABA) use averaged over the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Percentage of symptom-free days during the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Percentage of symptom-free nights during the last 3 weeks of the 6 week treatment period
Timeframe: Week 4 to Week 6
Percentage of rescue-free days during the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Percentage of rescue-free nights during the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Percentage of nights without awakenings due to asthma during the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Number of participants withdrawn due to lack of efficacy during the last 3 weeks of the 6-week treatment period
Timeframe: Week 4 to Week 6
Interventions:
Drug: FP 100
Drug: GSK2190915 100
Drug: GSK2190915 300
Drug: montelukast
Drug: placebo
Drug: FP/SAL 100/50
Enrollment:
162
Observational study model:
Not applicable
Primary completion date:
2011-25-10
Time perspective:
Not applicable
Clinical publications:
Snowise N, Clements D, Ho Shu-Yen , Follows R.Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma.Curr Med Res Opin.2013;29(12):1663-1674
Medical condition
Asthma
Product
fiboflapon, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
September 2010 to October 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
12+ years
Accepts healthy volunteers
No
- Age: 12 years of age or older
- Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
- History of life-threatening asthma
- Recent asthma exacerbation
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Ocean, New Jersey, United States, 07712
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18020
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
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
2011-25-10
Actual study completion date
2011-25-10
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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