A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00118716 |
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Recruitment Status
:
Completed
First Posted
: July 12, 2005
Last Update Posted
: September 23, 2016
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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 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
Drug Information available for:
Fluticasone propionate
Salmeterol
Fluticasone
Salmeterol xinafoate
Fluticasone furoate
U.S. FDA Resources
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.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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.
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
Hide Study Locations
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 |
Study Data/Documents: Individual Participant Data Set
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Identifier: SFA100314
For additional information about this study please refer to the GSK Clinical Study Register
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:
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asthma bronchospasm |
Additional relevant MeSH terms:
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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 |