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This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly or a B-16 Arg/Gly Genotype and are Treated With Fluticasone Propionate/Salmeterol DISKUSâ„¢ Combination Product 100/50mcg or Salmeterol DISKUS 50 mcg BID
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/salmeterol | Drug | |||
| salmeterol xinafoate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT |
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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 | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19910613 | Derived | Bleecker ER, Nelson HS, Kraft M, Corren J, Meyers DA, Yancey SW, Anderson WH, Emmett AH, Ortega HG. Beta2-receptor polymorphisms in patients receiving salmeterol with or without fluticasone propionate. Am J Respir Crit Care Med. 2010 Apr 1;181(7):676-87. doi: 10.1164/200809-1511OC. Epub 2009 Nov 12. |
| 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 |
|---|---|---|---|
| SFA100062 | 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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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Fullerton | California | 92835 | United States |
| GSK Investigational Site | Huntington Beach | California | 92647 | United States |
| GSK Investigational Site | Inglewood | California | 90301 | United States |
| GSK Investigational Site | Irvine | California | 92618 | United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Long Beach | California | 90808 | United States |
| GSK Investigational Site | Los Angeles | California | 90025 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | Spring Valley | California | 91978 | United States |
| GSK Investigational Site | Stockton | California | 95207 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Denver | Colorado | 80209 | United States |
| GSK Investigational Site | Lakewood | Colorado | 80401 | United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Waterbury | Connecticut | 06708 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32207 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Sarasota | Florida | 34233 | United States |
| GSK Investigational Site | South Miami | Florida | 33143 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30310 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30045 | United States |
| GSK Investigational Site | Lilburn | Georgia | 30047 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46208 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66210 | United States |
| GSK Investigational Site | Covington | Louisiana | 70433 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70002 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71104 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71105 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21237 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02118 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Warrensburg | Missouri | 64093 | United States |
| GSK Investigational Site | Papillion | Nebraska | 68046 | United States |
| GSK Investigational Site | Hackensack | New Jersey | 07601 | United States |
| GSK Investigational Site | Newark | New Jersey | 07103-2499 | United States |
| GSK Investigational Site | Bay Shore | New York | 11706 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Rochester | New York | 14618 | United States |
| GSK Investigational Site | Asheville | North Carolina | 28801 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19143 | United States |
| GSK Investigational Site | Upland | Pennsylvania | 19013 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29414 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203-1424 | United States |
| GSK Investigational Site | Corsicana | Texas | 75110 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | El Paso | Texas | 79902 | United States |
| GSK Investigational Site | El Paso | Texas | 79925 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76104 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | Kerrville | Texas | 78028 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | South Burlington | Vermont | 05403 | United States |
| GSK Investigational Site | Richmond | Virginia | 23229 | United States |
| GSK Investigational Site | Bellingham | Washington | 98225 | United States |
| GSK Investigational Site | Kirkland | Washington | 98034 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53209-0996 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53219 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| GSK Investigational Site | West Allis | Wisconsin | 53227 | United States |
| GSK Investigational Site | Nairobi | 00200 | Kenya |
| GSK Investigational Site | Lima | Lima Province | Lima 1 | Peru |
| GSK Investigational Site | San Isidro | Lima region | Lima 27 | Peru |
| GSK Investigational Site | Hato Rey | Puerto Rico | 00917 | Puerto Rico |
| GSK Investigational Site | Ponce | Puerto Rico | 00716 | Puerto Rico |
For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100062 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100062 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100062 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100062 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100062 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SFA100062 | 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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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| 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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