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The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone propionate | Active Comparator |
| |
| Fluticasone propionate/salmeterol combination | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Twice daily dosing |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Average ICS treatment dose over the treatment period | Every 8 weeks through 40 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function measures | Every 8 weeks through 40 weeks of 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 | Birmingham | Alabama | 35294-0012 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Stauffer JL, Yancey SW, Baitinger LA, Prillaman BA, Dorinsky PM. Measuring airway hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Proc Am Thorac Soc 2006;3:A213 |
| 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 |
|---|---|---|---|
| SAM40065 | 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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| Placebo | Drug | Twice daily dosing |
|
| FP 100mcg | Drug | Twice daily dosing |
|
| FP 250mcg | Drug | Twice daily dosing |
|
| FP 500mcg | Drug | Twice daily dosing |
|
| FSC 100/50mcg | Drug | Twice daily dosing |
|
| FSC 250/50mcg | Drug | Twice daily dosing |
|
| FSC500/50mcg | Drug | Twice daily dosing |
|
| Jasper |
| Alabama |
| 35501 |
| United States |
| GSK Investigational Site | Glendale | Arizona | 85304 | United States |
| GSK Investigational Site | Tucson | Arizona | 85724 | 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 | 90025 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Los Angeles | California | 90095-1752 | United States |
| GSK Investigational Site | Denver | Colorado | 80230 | United States |
| GSK Investigational Site | Englewood | Colorado | 80112 | United States |
| GSK Investigational Site | Fort Collins | Colorado | 80526 | United States |
| GSK Investigational Site | Pueblo | Colorado | 81008 | United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32207 | United States |
| GSK Investigational Site | Longwood | Florida | 32750 | United States |
| GSK Investigational Site | Tampa | Florida | 33609 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Coeur d'Alene | Idaho | 83814 | United States |
| GSK Investigational Site | Oak Brook | Illinois | 60523 | United States |
| GSK Investigational Site | South Bend | Indiana | 46617 | United States |
| GSK Investigational Site | Des Moines | Iowa | 50309-1426 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Livonia | Michigan | 48152 | United States |
| GSK Investigational Site | Chesterfield | Missouri | 63017 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68131 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68198-2456 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | 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 | 44195 | United States |
| GSK Investigational Site | Toledo | Ohio | 43614-5809 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Lake Oswego | Oregon | 97035 | United States |
| GSK Investigational Site | Upland | Pennsylvania | 19013 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37922 | United States |
| GSK Investigational Site | Dallas | Texas | 75231-4307 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Friendswood | Texas | 77546 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Danville | Virginia | 24541 | United States |
| GSK Investigational Site | Richmond | Virginia | 23229 | United States |
| GSK Investigational Site | Bellingham | Washington | 98226 | United States |
| GSK Investigational Site | Seattle | Washington | 98105 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53209-0996 | United States |
| GSK Investigational Site | Rio de Janeiro | Rio de Janeiro | 21941-590 | Brazil |
| GSK Investigational Site | Florianópolis | Santa Catarina | 88040970 | Brazil |
| GSK Investigational Site | São Paulo | São Paulo | Brazil |
| GSK Investigational Site | Sofia | 1431/1000 | Bulgaria |
| GSK Investigational Site | Varna | 9010 | Bulgaria |
| GSK Investigational Site | San Juan | Puerto Rico | 00921 | Puerto Rico |
For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40065 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40065 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40065 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40065 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40065 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40065 | Study Protocol | 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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