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

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ClinicalTrials.gov Identifier: NCT00118716
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2003
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118716


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Locations
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
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
Englewood, 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, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, Nebraska
GSK Investigational Site
Papillion, Nebraska, United States, 68046
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
GSK Investigational Site
Portland, Oregon, United States, 97213
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
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
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
Madison, Wisconsin, United States, 53792
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00118716     History of Changes
Other Study ID Numbers: SFA100314
First Posted: July 12, 2005    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists