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

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118690

Hide Study Locations

Locations

United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
Costa Mesa, California, United States, 92626
GSK Investigational Site
East Artesia, California, United States, 90706
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Los Angeles, California, United States, 90015
GSK Investigational Site
Madera, California, United States, 93638
GSK Investigational Site
Oakland, California, United States, 94618
GSK Investigational Site
Rolling Hills Est, California, United States, 90274
GSK Investigational Site
Vista, California, United States, 92083
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80206
GSK Investigational Site
Pueblo, Colorado, United States, 81008
United States, Florida
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
GSK Investigational Site
Delray Beach, Florida, United States, 33484
GSK Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30062
GSK Investigational Site
Savannah, Georgia, United States, 31419
GSK Investigational Site
Savannah, Georgia, United States, 31406
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02111
United States, Minnesota
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59804
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
GSK Investigational Site
Mount Laurel, New Jersey, United States, 08054
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Altoona, Pennsylvania, United States, 16601
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29407
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
Nashville, Tennessee, United States, 37203-1424
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
El Paso, Texas, United States, 79925
GSK Investigational Site
Houston, Texas, United States, 77054
GSK Investigational Site
San Antonio, Texas, United States, 78205
United States, Utah
GSK Investigational Site
Layton, Utah, United States, 84041
GSK Investigational Site
Provo, Utah, United States, 84604
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
United States, Virginia
GSK Investigational Site
Burke, Virginia, United States, 22015

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00118690 History of Changes
Other Study ID Numbers:	SFA100316
Study First Received:	July 1, 2005
Last Updated:	May 31, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

asthma
bronchospasm

Additional relevant MeSH terms:

Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013