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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16601
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Est, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Madera, California, United States, 93638
Status
Study Complete
Location
GSK Investigational Site
East Artesia, California, United States, 90706
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90015
Status
Study Complete
Location
GSK Investigational Site
Mount Laurel, New Jersey, United States, 08054
Status
Study Complete
Location
GSK Investigational Site
Delray Beach, Florida, United States, 33484
Status
Study Complete
Location
GSK Investigational Site
Pueblo, Colorado, United States, 81008
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94618
Status
Study Complete
Location
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
Status
Study Complete
Location
GSK Investigational Site
Kernersville, North Carolina, United States, 27284
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
Location
GSK Investigational Site
Missoula, Montana, United States, 59804
Status
Study Complete
Location
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Layton, Utah, United States, 84041
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31419
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Study Complete
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
Refer to study documents
Recruitment status
Completed
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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Additional information
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