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
    • Inclusion criteria:
    • Diagnosed with persistent asthma for 3 months or longer.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29407
    Status
    Study Complete
    Contact us
    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
    Contact us
    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 51 Results

    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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