A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
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
1 other identifier
interventional
227
1 country
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2003
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 1, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedSeptember 23, 2016
September 1, 2016
2 years
July 1, 2005
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in maximal decline from baseline in lung function following exercise challenge after 4-weeks of double-blind treatment compared to decline in lung function before treatment.
Secondary Outcomes (1)
Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (51)
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
East Artesia, California, 90706, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90015, United States
GSK Investigational Site
Madera, California, 93638, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Oakland, California, 94618, United States
GSK Investigational Site
Rolling Hills Est, California, 90274, United States
GSK Investigational Site
Vista, California, 92083, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Pueblo, Colorado, 81008, United States
GSK Investigational Site
Altamonte Springs, Florida, 32701, United States
GSK Investigational Site
Delray Beach, Florida, 33484, United States
GSK Investigational Site
St. Petersburg, Florida, 33710, United States
GSK Investigational Site
Tampa, Florida, 33607, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
GSK Investigational Site
Savannah, Georgia, 31419, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Boston, Massachusetts, 02111, United States
GSK Investigational Site
Robbinsdale, Minnesota, 55422, United States
GSK Investigational Site
Missoula, Montana, 59804, United States
GSK Investigational Site
Omaha, Nebraska, 68114, United States
GSK Investigational Site
Mount Laurel, New Jersey, 08054, United States
GSK Investigational Site
Kernersville, North Carolina, 27284, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Altoona, Pennsylvania, 16601, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Upland, Pennsylvania, 19013, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Nashville, Tennessee, 37203-1424, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
El Paso, Texas, 79902, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2005
First Posted
July 12, 2005
Study Start
December 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
September 23, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.