Last updated: 11/04/2018 11:58:03

A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

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GSK study ID
SFA100316
See study documents
Clinicaltrials.gov ID
NCT00118690
EudraCT ID
Not applicable
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 Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects with Activity-Induced Bronchospasm
Trial description: During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone propionate/salmeterol
    • Enrollment:
    227
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Bronchospasm
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    December 2003 to December 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    4 - 17 years
    Accepts healthy volunteers
    No
    • Diagnosed with persistent asthma for 3 months or longer.
    • Experience worsened asthma symptoms during physical activity.
    • Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months.
    • Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosed with persistent asthma for 3 months or longer.
    • Experience worsened asthma symptoms during physical activity.
    • Using or used an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).
    Exclusion criteria:
    • Used systemic steroids as either liquids, pills, or injections to treat asthma within the last 3 months.
    • Have only intermittent, seasonal, or exercise induced asthma, and not persistent asthma.
    • Admitted to a hospital within the last 6 months due to asthma symptoms.
    • Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.).
    • The study physician will evaluate other medical criteria.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29407
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Altoona, Pennsylvania, United States, 16601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68114
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marietta, Georgia, United States, 30062
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mount Pleasant, South Carolina, United States, 29464
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rolling Hills Est, California, United States, 90274
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madera, California, United States, 93638
    Status
    Study Complete
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    Location
    GSK Investigational Site
    East Artesia, California, United States, 90706
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80206
    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
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Provo, Utah, United States, 84604
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Normal, Illinois, United States, 61761
    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
    Nashville, Tennessee, United States, 37203-1424
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lawrenceville, Georgia, United States, 30045
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bethesda, Maryland, United States, 20814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Englewood, Colorado, United States, 80112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mount Laurel, New Jersey, United States, 08054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Delray Beach, Florida, United States, 33484
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pueblo, Colorado, United States, 81008
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33613
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jonesboro, Arkansas, United States, 72401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oakland, California, United States, 94618
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Altamonte Springs, Florida, United States, 32701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kernersville, North Carolina, United States, 27284
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Upland, Pennsylvania, United States, 19013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Missoula, Montana, United States, 59804
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Robbinsdale, Minnesota, United States, 55422
    Status
    Study Complete
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    Location
    GSK Investigational Site
    El Paso, Texas, United States, 79902
    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
    Vista, California, United States, 92083
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Burke, Virginia, United States, 22015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mission Viejo, California, United States, 92691
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Savannah, Georgia, United States, 31406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Iowa City, Iowa, United States, 52242
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02111
    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
    Layton, Utah, United States, 84041
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73120
    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
    El Paso, Texas, United States, 79925
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sunset, Louisiana, United States, 70584
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Savannah, Georgia, United States, 31419
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33710
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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