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Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 years of age

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GSK study ID
114255
See study documents
Clinicaltrials.gov ID
NCT01156792
See results summary
EudraCT ID
2010-019466-81
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2011-25-10
    Observational study model:
    Not applicable
    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
    Status
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78750
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Burlington, Vermont, United States, 05403
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bellevue, Nebraska, United States, 68123-4303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55402
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ocean, New Jersey, United States, 07712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bethlehem, Pennsylvania, United States, 18020
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90048
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Coral Gables, Florida, United States, 33134
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orangeburg, South Carolina, United States, 29118
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53792
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Metairie, Louisiana, United States, 70006
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bangor, Maine, United States, 04401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lenexa, Kansas, United States, 66215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waco, Texas, United States, 76712
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ypsilanti, Michigan, United States, 48197
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33173
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wilmington, North Carolina, United States, 28401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vista, California, United States, 92083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Owensboro, Kentucky, United States, 42301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plano, Texas, United States, 75024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63110
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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.

    Additional information about the trial

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