Last updated: 11/04/2018 11:57:47

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
SFA100314
See study documents
Clinicaltrials.gov ID
NCT00118716
See results summary
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:

Maximal percent change in forced expiratory volume in 1 second (FEV1) following exercise challenge at Week 4

Timeframe: Baseline and Week 4

Secondary outcomes:

Four-hour serial post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1

Timeframe: Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1

Change from baseline in Morning Peak Expiratory Flow (AM PEF)

Timeframe: Baseline and Up to Week 4

Change from baseline in Evening (PM) PEF

Timeframe: Baseline and up to Week 4

Percent of rescue-free days

Timeframe: Up to Week 4

Percent of symptom-free days

Timeframe: Up to Week 4

Change from Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ)

Timeframe: Baseline (Week 0) and up to Week 4

Interventions:
  • Drug: Fluticasone propionate/salmeterol
  • Drug: Fluticasone Propionate
    • Enrollment:
    248
    Primary completion date:
    2006-23-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Pearlman D, Qaqundah P, Matz J, et al. Fluticasone propionate/salmeterol and exercise-induced asthma in children with persistent asthma. Pediatr Pulmonol 2009;44:429–35.
    Medical condition
    Bronchospasm
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    December 2003 to April 2006
    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.
    • Experienced worsened asthma symptoms during physical activity.
    • Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 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.
    • Experienced worsened asthma symptoms during physical activity.
    • Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).
    Exclusion criteria:
    • Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
    • Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
    • Admitted to a hospital within the previous 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
    Orange, California, United States, 92868
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lilburn, Georgia, United States, 30047
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Metairie, Louisiana, United States, 70001
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33156
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Diego, California, United States, 92120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 50 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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-23-04
    Actual study completion date
    2006-23-04

    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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