Last updated: 11/07/2018 07:40:10
Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 300mg as Compared to Adding Montelukast 10mg or Placebo Tablets QD to Fluticasone Propionate/Salmeterol 250/50mcg Diskus BID
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Trough (AM or morning pre-dose and pre-rescue bronchodilator) Forced Expiratory Volume in 1 second (FEV1) at the end of the 6 week treatment period
Timeframe: Week 6
Secondary outcomes:
Daily trough (AM pre-dose and pre-rescue bronchodilator) Peak expiratory flow (PEF) averaged over the last 3 weeks of the 6 week treatment period
Timeframe: Week 4 to Week 6
Daily PM or evening PEF averaged over the last 3 weeks of the 6 week treatment period
Timeframe: Week 4 to Week 6
Daily (average of AM and PM) PEF averaged over the last 3 weeks of the 6 week treatment period
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/SAL 250/50mcg BID
Drug: GSK2190915 200mg QD (AM)
Drug: GSK2190915 100mg QD (AM)
Drug: Montelukast 10mg QD (PM)
Drug: Placebo tablets (2) (AM)
Drug: Placebo capsule (PM)
Enrollment:
145
Observational study model:
Not applicable
Primary completion date:
2011-11-10
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)
December 2010 to October 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Age: 18 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: 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
Trial location(s)
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
2011-11-10
Actual study completion date
2011-11-10
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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