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The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects 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 inhaled corticosteroid treatment dose over the treatment period | Every 8 weeks for the 40 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function measures | Every 8 weeks for the 40 week treatment period |
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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 | 35209 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Dorinsky P, Yancey S, Baitinger L, Stauffer J. Measuring Airway Hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Eur Respir J 2006;28(50):319s. | ||
| 18206361 | Background | Kerwin EM, Nathan RA, Meltzer EO, Ortega HG, Yancey SW, Schoaf L, Dorinsky PM. Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respir Med. 2008 Apr;102(4):495-504. doi: 10.1016/j.rmed.2007.12.002. Epub 2008 Feb 21. | |
| 18328683 |
| 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 |
|---|---|---|---|
| SAM40086 | 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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| FP 100mcg | Drug | Twice daily dosing |
|
| FP 500mcg | Drug | Twice daily dosing |
|
| FP 250mcg | Drug | Twice daily dosing |
|
| FSC 100/50mcg | Drug | Twice daily dosing |
|
| FSC 250/50mcg | Drug | Twice daily dosing |
|
| FSC 500/50mcg | Drug | Twice daily dosing |
|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85712 | United States |
| GSK Investigational Site | Carmichael | California | 95608 | United States |
| GSK Investigational Site | Palmdale | California | 93551 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | San Jose | California | 95117 | United States |
| GSK Investigational Site | San Jose | California | 95128 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06106 | United States |
| GSK Investigational Site | Trumbull | Connecticut | 06611 | United States |
| GSK Investigational Site | Bay Pines | Florida | 33744 | United States |
| GSK Investigational Site | Gainesville | Florida | 32610 | United States |
| GSK Investigational Site | Sarasota | Florida | 34233 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Normal | Illinois | 61761 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46208 | United States |
| GSK Investigational Site | Lafayette | Indiana | 47904 | United States |
| GSK Investigational Site | Iowa City | Iowa | 52242 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40215 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70119 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21224 | United States |
| GSK Investigational Site | Petoskey | Michigan | 49770 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55407 | United States |
| GSK Investigational Site | Butte | Montana | 59701 | United States |
| GSK Investigational Site | Papillion | Nebraska | 68046 | United States |
| GSK Investigational Site | Absecon | New Jersey | 8201 | United States |
| GSK Investigational Site | Cherry Hill | New Jersey | 08003 | United States |
| GSK Investigational Site | Rockville Centre | New York | 11570 | United States |
| GSK Investigational Site | Asheville | North Carolina | 28801 | United States |
| GSK Investigational Site | Statesville | North Carolina | 28625 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Sylvania | Ohio | 43560 | United States |
| GSK Investigational Site | Toledo | Ohio | 43617 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Portland | Oregon | 97213 | United States |
| GSK Investigational Site | Tigard | Oregon | 97223 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Lincoln | Rhode Island | 2865 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203-1424 | United States |
| GSK Investigational Site | Houston | Texas | 77090 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | United States |
| GSK Investigational Site | Bellingham | Washington | 98226 | United States |
| GSK Investigational Site | Morgantown | West Virginia | 26505 | United States |
| GSK Investigational Site | Salvador | Estado de Bahia | 41940-060 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 40110-160 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035 003 | Brazil |
| GSK Investigational Site | Riga | LV 1002 | Latvia |
| GSK Investigational Site | Riga | LV 1003 | Latvia |
| GSK Investigational Site | Ponce | Puerto Rico | 00716 | Puerto Rico |
| Background |
| Koenig SM, Murray JJ, Wolfe J, Andersen L, Yancey S, Prillaman B, Stauffer J, Dorinsky P. Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma? Respir Med. 2008 May;102(5):665-73. doi: 10.1016/j.rmed.2007.12.023. Epub 2008 Mar 6. |
For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40086 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40086 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40086 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40086 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40086 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40086 | 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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