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This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/salmeterol powder | Drug | |||
| fluticasone propionate powder | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma exacerbation rate per patient per year |
| Measure | Description | Time Frame |
|---|---|---|
| Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days |
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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 | Birmingham | Alabama | 35205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18462564 | Background | Bailey W, Castro M, Matz J, White M, Dransfield M, Yancey S, Ortega H. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin. 2008 Jun;24(6):1669-82. doi: 10.1185/03007990802119111. Epub 2008 May 6. | |
| 23706709 | Derived |
| 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 |
|---|---|---|---|
| SFA103153 | Individual Participant Data Set | 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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| Birmingham |
| Alabama |
| 35209 |
| United States |
| GSK Investigational Site | Birmingham | Alabama | 35294-0012 | United States |
| GSK Investigational Site | Mobile | Alabama | 36608 | United States |
| GSK Investigational Site | Montgomery | Alabama | 36106 | United States |
| GSK Investigational Site | Muscle Shoals | Alabama | 35662 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72204 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Palmdale | California | 93551 | United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | San Francisco | California | 94102 | United States |
| GSK Investigational Site | Stockton | California | 95207 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06105 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20060 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32205 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Columbus | Georgia | 31904 | United States |
| GSK Investigational Site | Decatur | Georgia | 30030 | United States |
| GSK Investigational Site | Martinez | Georgia | 30907 | United States |
| GSK Investigational Site | Savannah | Georgia | 31406 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Flossmoor | Illinois | 60422 | United States |
| GSK Investigational Site | Lafayette | Louisiana | 70503 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Sunset | Louisiana | 70584 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20814 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02114 | United States |
| GSK Investigational Site | Detroit | Michigan | 48201 | United States |
| GSK Investigational Site | Ypsilanti | Michigan | 48197 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Picayune | Mississippi | 39466 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Verona | New Jersey | 07044 | United States |
| GSK Investigational Site | Brooklyn | New York | 11215 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | West Sayville | New York | 11796 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Elizabeth City | North Carolina | 27909 | United States |
| GSK Investigational Site | High Point | North Carolina | 27262 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Sylvania | Ohio | 43560 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Jenkintown | Pennsylvania | 19406 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19102 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104-6160 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29607 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37909 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203-1424 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37208 | United States |
| GSK Investigational Site | Austin | Texas | 78750 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | Newport News | Virginia | 23601 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23507 | United States |
| GSK Investigational Site | Richmond | Virginia | 23225 | United States |
| GSK Investigational Site | Richmond | Virginia | 23229 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002. |
| 20429821 | Derived | Camargo CA Jr, Sutherland ER, Bailey W, Castro M, Yancey SW, Emmett AH, Stempel DA. Effect of increased body mass index on asthma risk, impairment and response to asthma controller therapy in African Americans. Curr Med Res Opin. 2010 Jul;26(7):1629-35. doi: 10.1185/03007995.2010.483113. |
For additional information about this study please refer to the GSK Clinical Study Register |
| SFA103153 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA103153 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA103153 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA103153 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA103153 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA103153 | Dataset Specification | 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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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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