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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate/salmeterol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily lung function tests and subject assessed diary measures analyzed over the 4-week treatment. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| http://www.findclinicalstudy.com | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SFA100316 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| East Artesia |
| California |
| 90706 |
| United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Los Angeles | California | 90015 | United States |
| GSK Investigational Site | Madera | California | 93638 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Oakland | California | 94618 | United States |
| GSK Investigational Site | Rolling Hills Est | California | 90274 | United States |
| GSK Investigational Site | Vista | California | 92083 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Englewood | Colorado | 80112 | United States |
| GSK Investigational Site | Pueblo | Colorado | 81008 | United States |
| GSK Investigational Site | Altamonte Springs | Florida | 32701 | United States |
| GSK Investigational Site | Delray Beach | Florida | 33484 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33710 | United States |
| GSK Investigational Site | Tampa | Florida | 33607 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30045 | United States |
| GSK Investigational Site | Marietta | Georgia | 30062 | United States |
| GSK Investigational Site | Savannah | Georgia | 31406 | United States |
| GSK Investigational Site | Savannah | Georgia | 31419 | United States |
| GSK Investigational Site | Normal | Illinois | 61761 | United States |
| GSK Investigational Site | Iowa City | Iowa | 52242 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40202 | United States |
| GSK Investigational Site | Sunset | Louisiana | 70584 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20814 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02111 | United States |
| GSK Investigational Site | Robbinsdale | Minnesota | 55422 | United States |
| GSK Investigational Site | Missoula | Montana | 59804 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68114 | United States |
| GSK Investigational Site | Mount Laurel | New Jersey | 08054 | United States |
| GSK Investigational Site | Kernersville | North Carolina | 27284 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Altoona | Pennsylvania | 16601 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Upland | Pennsylvania | 19013 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203-1424 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | El Paso | Texas | 79902 | United States |
| GSK Investigational Site | El Paso | Texas | 79925 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | San Antonio | Texas | 78205 | United States |
| GSK Investigational Site | Layton | Utah | 84041 | United States |
| GSK Investigational Site | Provo | Utah | 84604 | United States |
| GSK Investigational Site | South Burlington | Vermont | 05403 | United States |
| GSK Investigational Site | Burke | Virginia | 22015 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100316 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100316 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100316 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100316 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D001986 | Bronchial Spasm |
| D009043 | Motor Activity |
| D001250 | Asthma, Exercise-Induced |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D012130 | Respiratory Hypersensitivity |
| D000092202 | Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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