Not Signed In -
Asthma |
Bronchial Asthma |
Clinical Trial: A Study Measuring Asthma Control in Pediatric and Adolescent Subjects Whose Asthma is Worsened by Activity Or Exercise
This study is currently recruiting patients.
|
Purpose
During this study, eligible children 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.
| Condition | Intervention | Phase |
|---|---|---|
| Bronchospasm Asthma, Exercise-Induced | Drug: Fluticasone propionate/salmeterol Drug: Fluticasone propionate | Phase IV |
MedlinePlus related topics: Asthma; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: 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: Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.
Expected Total Enrollment: 230
Secondary Outcomes: Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.
Expected Total Enrollment: 230
Study start: December 2003
Eligibility
Ages Eligible for Study: 4 Years - 17 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Have been diagnosed with persistent asthma for 3 months or longer.
- Experience worsened asthma symptoms during physical activity.
- Are/have been using an inhaled steroid for the last 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, or Vanceril).
Exclusion Criteria:
- Have 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.
- Have been admitted to a hospital within the last 6 months due to asthma symptoms.
- Have 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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00118690
GSK Call Center 877-379-3718
California
Onsy Basta, Los Angeles, California, 90015, United States; Not yet recruiting
Onsy Basta 213-861-5845
Kelly Meade, Oakland, California, 94609, United States; Recruiting
Kelly Meade 510-428-3888 Ext. 4145
Steven Weinstein, Huntington Beach, California, 92647, United States; Recruiting
Steven Weinstein 714-848-8585
Robert Ziering, Vista, California, 92083, United States; Recruiting
Robert Ziering 760-941-4444
Colorado
Leon Greos, Englewood, Colorado, 80112, United States; Recruiting
Leon Greos 303-632-3646
Florida
Richard Lockey, Tampa, Florida, 33613, United States; Recruiting
Richard Lockey 813-631-4024
Georgia
Jack Eades, Savannah, Georgia, 31405, United States; Recruiting
Jack Eades 912-303-9355
Brad Goodman, Savannah, Georgia, 31406, United States; Recruiting
Brad Goodman 912-356-3619
Iowa
Richard Ahrens C, Iowa City, Iowa, 52242, United States; Recruiting
Richard C Ahrens 319-384-5437
Massachusetts
William Yee, Boston, Massachusetts, 02111, United States; Recruiting
William Yee 617-636-7917
Minnesota
David Graft, St. Louis Park, Minnesota, 55416, United States; Recruiting
David Graft 952-993-3805
Montana
Wayne Sinclair, Missoula, Montana, 59804, United States; Recruiting
406-549-1124
New Jersey
Donald Dvorin, Forked River, New Jersey, 08731, United States; Recruiting
Donald Dvorin 609-693-0630
Oklahoma
Martha Tarpay, Oklahoma City, Oklahoma, 73134, United States; Recruiting
Martha Tarpay 405-752-0393
Oregon
Jon Van Valkenburg, Medford, Oregon, 97504, United States; Recruiting
Jon Van Valkenburg 541-734-3560
South Carolina
Andrew Davidson, Mt. Pleasant, South Carolina, 29464, United States; Not yet recruiting
Andrew Davidson 843-881-1151
Richard Sterling, Orangeburg, South Carolina, 29118, United States; Recruiting
Richard Sterling 803-534-3324
Texas
John Meiser, Dallas, Texas, 75230, United States; Recruiting
John Meiser 972-566-7788
Laura Somerville, Houston, Texas, 77054, United States; Recruiting
Laura Somerville 713-797-6716
Utah
Edward Campbell, Provo, Utah, 84604, United States; Not yet recruiting
Edward Campbell 801-343-3641
Vermont
Edward Kent, Jr., South Burlington, Vermont, 05403, United States; Recruiting
Edward Kent, Jr. 802-864-0294 Ext. 25
Wisconsin
Kevin Kelly, Milwaukee, Wisconsin, 53226, United States; Recruiting
Kevin Kelly 414-266-6840
Study chairs or principal investigators
GSK Clinical Trial, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: SFA100316
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 11, 2005
ClinicalTrials.gov Identifier: NCT00118690
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 11, 2005
ClinicalTrials.gov Identifier: NCT00118690
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
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