A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bronchospasm Activity/Exercise Induced Bronchospasm	Drug: Fluticasone propionate/salmeterol	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Exercise and Physical Fitness

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Fluticasone furoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.


Estimated Enrollment:	230
Study Start Date:	December 2003

Intervention Details:

Other Name: Fluticasone propionate/salmeterol

Eligibility


Ages Eligible for Study:	4 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118716

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Locations


United States, California
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
Palmdale, California, United States, 93551
GSK Investigational Site
Paramount, California, United States, 90723
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
Torrance, California, United States, 90503
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
GSK Investigational Site
Centennial, Colorado, United States, 80112
GSK Investigational Site
Lakewood, Colorado, United States, 80401
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
Miami, Florida, United States, 33176
GSK Investigational Site
Tallahassee, Florida, United States, 32308
United States, Georgia
GSK Investigational Site
Lilburn, Georgia, United States, 30047
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Hoffman Estates, Illinois, United States, 60195
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70001
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
Glen Burnie, Maryland, United States, 21061
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, New Jersey
GSK Investigational Site
Skillman, New Jersey, United States, 08558
GSK Investigational Site
Summit, New Jersey, United States, 07901
United States, New York
GSK Investigational Site
Commack, New York, United States, 11725
GSK Investigational Site
Utica, New York, United States, 13502
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
GSK Investigational Site
Dayton, Ohio, United States, 45404
United States, Oregon
GSK Investigational Site
Gresham, Oregon, United States, 97030
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033-0850
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19135
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
GSK Investigational Site
Dyersburg, Tennessee, United States, 38024
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75204
GSK Investigational Site
Houston, Texas, United States, 77074
United States, Utah
GSK Investigational Site
Murray, Utah, United States, 84107
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23298
United States, Wisconsin
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Publications:

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.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00118716 History of Changes
Other Study ID Numbers:	SFA100314
Study First Received:	July 1, 2005
Last Updated:	June 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


asthma bronchospasm

Additional relevant MeSH terms:


Bronchial Spasm Bronchial Diseases Respiratory Tract Diseases Fluticasone Salmeterol Adrenergic Agents Adrenergic Agonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Anti-Allergic Agents Anti-Asthmatic Agents	Anti-Inflammatory Agents Autonomic Agents Bronchodilator Agents Dermatologic Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015