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
248
1 country
50
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
Typical duration for phase_4
50 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 23, 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
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2006
CompletedResults Posted
Study results publicly available
February 5, 2019
CompletedFebruary 5, 2019
December 1, 2017
2.3 years
July 1, 2005
June 23, 2017
September 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Maximal percent change in FEV1 following exercise challenge was defined as the percent change from pre-exercise baseline FEV1 to the minimum FEV1 collected within one hour following exercise challenge. Maximal percent change in FEV1 following exercise challenge was mean maximal percent change from pre-exercise baseline compared between treatment groups at Treatment Week 4. FEV1 was measured 5, 10, 15, 30, and 60 minutes post-exercise. The minimum FEV1 measured across these time points, regardless of any missing time points, will be used for the calculation of maximal percent change.
Baseline and Week 4
Secondary Outcomes (6)
Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1
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)
Baseline and Up to Week 4
Change From Baseline in Evening (PM) PEF
Baseline and up to Week 4
Percent of Rescue-free Days
Up to Week 4
Percent of Symptom-free Days
Up to Week 4
- +1 more secondary outcomes
Study Arms (2)
FSC 100/50 mcg BID
EXPERIMENTALParticipants received FSC 100/50 microgram (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days
FP 100 mcg BID
EXPERIMENTALParticipants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (50)
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Palmdale, California, 93551, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Torrance, California, 90503, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Lakewood, Colorado, 80401, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Lilburn, Georgia, 30047, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Hoffman Estates, Illinois, 60195, United States
GSK Investigational Site
Metairie, Louisiana, 70001, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Glen Burnie, Maryland, 21061, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Papillion, Nebraska, 68046, United States
GSK Investigational Site
Skillman, New Jersey, 08558, United States
GSK Investigational Site
Summit, New Jersey, 07901, United States
GSK Investigational Site
Commack, New York, 11725, United States
GSK Investigational Site
Utica, New York, 13502, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Dayton, Ohio, 45404, United States
GSK Investigational Site
Gresham, Oregon, 97030, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033-0850, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19135, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Dyersburg, Tennessee, 38024, United States
GSK Investigational Site
Knoxville, Tennessee, 37922, United States
GSK Investigational Site
Dallas, Texas, 75204, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Murray, Utah, 84107, United States
GSK Investigational Site
Richmond, Virginia, 23298, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Pearlman D, Qaqundah P, Matz J, Yancey SW, Stempel DA, Ortega HG. Fluticasone propionate/salmeterol and exercise-induced asthma in children with persistent asthma. Pediatr Pulmonol. 2009 May;44(5):429-35. doi: 10.1002/ppul.20962.
PMID: 19382218BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- 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 23, 2003
Primary Completion
April 1, 2006
Study Completion
April 23, 2006
Last Updated
February 5, 2019
Results First Posted
February 5, 2019
Record last verified: 2017-12
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.