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To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone propionate/salmeterol combination | Experimental | study drug |
|
| Fluticasone propionate | Experimental | study drug |
|
| Placebo | Experimental | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP 100mcg | Drug | Once-daily dosing |
| |
| FSC 100/50mcg |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline at endpoint in daily PM PEF | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Various pulmonary function endpoints | 12 weeks |
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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 | Ozark | Alabama | 36360 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SAS30021 | Informed Consent Form | 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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| Drug |
Once-daily dosing |
|
| Placebo | Drug | Once-daily dosing |
|
| Tucson |
| Arizona |
| 85716 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85746 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Beverly Hills | California | 90212 | United States |
| GSK Investigational Site | Crescent City | California | 95531 | United States |
| GSK Investigational Site | Dinuba | California | 93618 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | La Jolla | California | 92093 | United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Newport Beach | California | 92660 | United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | Palmdale | California | 93551 | United States |
| GSK Investigational Site | Panorama City | California | 91402 | United States |
| GSK Investigational Site | Paramount | California | 90723 | United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | San Francisco | California | 94102 | United States |
| GSK Investigational Site | San Jose | California | 95117 | United States |
| GSK Investigational Site | Sherman Oaks | California | 91403 | United States |
| GSK Investigational Site | Vista | California | 92083 | United States |
| GSK Investigational Site | Vista | California | 92084 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Centennial | Colorado | 80112 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Denver | Colorado | 80218 | United States |
| GSK Investigational Site | Denver | Colorado | 80230 | United States |
| GSK Investigational Site | Pueblo | Colorado | 81008 | United States |
| GSK Investigational Site | Altamonte Springs | Florida | 32701 | United States |
| GSK Investigational Site | Hialeah | Florida | 33013 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32216 | United States |
| GSK Investigational Site | Orlando | Florida | 32801 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Sarasota | Florida | 34233 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33710 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30309-7520 | United States |
| GSK Investigational Site | Augusta | Georgia | 30901 | United States |
| GSK Investigational Site | Barnesville | Georgia | 30204 | United States |
| GSK Investigational Site | Martinez | Georgia | 30907 | United States |
| GSK Investigational Site | Savannah | Georgia | 31406 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Glenview | Illinois | 60025 | United States |
| GSK Investigational Site | Hoffman Estates | Illinois | 60195 | United States |
| GSK Investigational Site | Park Ridge | Illinois | 60068 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46208 | United States |
| GSK Investigational Site | South Bend | Indiana | 46617 | United States |
| GSK Investigational Site | Lawrence | Kansas | 66047 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40222 | United States |
| GSK Investigational Site | Murray | Kentucky | 42071 | United States |
| GSK Investigational Site | Covington | Louisiana | 70433 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70001 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71104 | United States |
| GSK Investigational Site | Sunset | Louisiana | 70584 | United States |
| GSK Investigational Site | Newton | Massachusetts | 02462 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Taunton | Massachusetts | 02780 | United States |
| GSK Investigational Site | West Quincy | Massachusetts | 02169 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55416 | United States |
| GSK Investigational Site | Columbia | Missouri | 65212 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64108 | United States |
| GSK Investigational Site | St Louis | Missouri | 63108 | United States |
| GSK Investigational Site | St Louis | Missouri | 63139 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Missoula | Montana | 59804 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68130 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68134 | United States |
| GSK Investigational Site | Papillion | Nebraska | 68046 | United States |
| GSK Investigational Site | Berlin | New Jersey | 08009 | United States |
| GSK Investigational Site | Brick | New Jersey | 8724 | United States |
| GSK Investigational Site | East Orange | New Jersey | 7017 | United States |
| GSK Investigational Site | Ocean City | New Jersey | 07712 | United States |
| GSK Investigational Site | Verona | New Jersey | 7044 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87131 | United States |
| GSK Investigational Site | Buffalo | New York | 14222 | United States |
| GSK Investigational Site | Liverpool | New York | 13088 | United States |
| GSK Investigational Site | New Hyde Park | New York | 11042 | United States |
| GSK Investigational Site | Rockville Centre | New York | 11570 | United States |
| GSK Investigational Site | Vestal | New York | 13850 | United States |
| GSK Investigational Site | Asheville | North Carolina | 28801 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | United States |
| GSK Investigational Site | Durham | North Carolina | 27704 | United States |
| GSK Investigational Site | Elizabeth City | North Carolina | 27909 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Bend | Oregon | 97701 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Portland | Oregon | 97213 | United States |
| GSK Investigational Site | Portland | Oregon | 97223 | United States |
| GSK Investigational Site | Altoona | Pennsylvania | 16601 | United States |
| GSK Investigational Site | Blue Belle | Pennsylvania | 19422 | United States |
| GSK Investigational Site | Harrisburg | Pennsylvania | 17110 | United States |
| GSK Investigational Site | Lewisburg | Pennsylvania | 17837 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19135 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15202 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Upland | Pennsylvania | 19013 | United States |
| GSK Investigational Site | Lincoln | Rhode Island | 02865-4208 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29607 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37916 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37917 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37922 | United States |
| GSK Investigational Site | Austin | Texas | 78749 | 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 | Galveston | Texas | 77555-0188 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | Houston | Texas | 77065 | United States |
| GSK Investigational Site | Houston | Texas | 77074 | United States |
| GSK Investigational Site | Lake Jackson | Texas | 77566 | United States |
| GSK Investigational Site | New Braunfels | Texas | 78130 | United States |
| GSK Investigational Site | Plano | Texas | 75093 | United States |
| GSK Investigational Site | San Antonio | Texas | 78205 | United States |
| GSK Investigational Site | San Antonio | Texas | 78207 | United States |
| GSK Investigational Site | San Antonio | Texas | 78233 | United States |
| GSK Investigational Site | Layton | Utah | 84041 | United States |
| GSK Investigational Site | Murray | Utah | 84107 | United States |
| GSK Investigational Site | Burke | Virginia | 22015 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23510 | United States |
| GSK Investigational Site | Richmond | Virginia | 23229 | United States |
| GSK Investigational Site | Richmond | Virginia | 23298 | United States |
| GSK Investigational Site | Edmonds | Washington | 98026 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Charleston | West Virginia | 25301 | United States |
| GSK Investigational Site | Greenfield | Wisconsin | 53228 | United States |
| GSK Investigational Site | La Crosse | Wisconsin | 54601 | United States |
| GSK Investigational Site | Buenos Aires | Buenos Aires | 1425 | Argentina |
| GSK Investigational Site | Santa Fe | Santa Fe Province | 3000 | Argentina |
| GSK Investigational Site | Buenos Aires | 1425 | Argentina |
| GSK Investigational Site | Santiago | Región Metro de Santiago | Chile |
| GSK Investigational Site | Viña del Mar | Valparaiso | Chile |
| GSK Investigational Site | Breña | Lima 5 | Peru |
| GSK Investigational Site | Ponce | Puerto Rico | 00716 | Puerto Rico |
| GSK Investigational Site | San Juan | Puerto Rico | 00935 | Puerto Rico |
For additional information about this study please refer to the GSK Clinical Study Register |
| SAS30021 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAS30021 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAS30021 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAS30021 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAS30021 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAS30021 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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