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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children 6 to less than 12 years of age |
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| Measure | Description | Time Frame |
|---|---|---|
| The change from basline in Childhood Asthma Control Test | 2 years | |
| The change from baseline in total Wasserfallen Clinical Symptom Score | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) | 2 years | |
| The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | 2 years |
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Inclusion Criteria:
A. Fluticasone DPI > 200 mcg/day or equivalent ex-valve dose ICS, or if ≤ 200 mcg fluticasone DPI or equivalent plus another daily controller medication (i.e. LABA, leukotriene antagonist or theophylline)
B. At least one of the following in the preceding 4 weeks prior to the screening visit:
C. Minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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Children aged 6 to less than 12 years old with moderate to severe allergic asthma for at least 12 months, treated with inhaled corticosteroids for at least 3 months but remaining symptomatic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | United States | ||
| Novartis Investigative Site |
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A venous blood sample was collected at either screening (Visit 1) or enrollment (Visit 2). These samples were collected for DNA extraction. The extracted DNA is stored at Novartis Pharmaceuticals Corporation for pharmacogenetic analysis and storage.
| The number of days of missed school. | 2 years |
| The number of days of missed work. | 2 years |
| Crescent City |
| California |
| 95531 |
| United States |
| Novartis Investigative Site | Fresno | California | 93726 | United States |
| Novartis Investigative Site | Oakland | California | 94609 | United States |
| Novartis Investigative Site | Orange | California | 92868 | United States |
| Novartis Investigative Site | Roseville | California | 95678 | United States |
| Novartis Investigative Site | Sacramento | California | 95819 | United States |
| Novartis Investigative Site | San Diego | California | 92120 | United States |
| Novartis Investigative Site | Walnut Creek | California | 94598 | United States |
| Novartis Investigative Site | Thornton | Colorado | 80233 | United States |
| Novartis Investigative Site | Albany | Georgia | 31707 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | United States |
| Novartis Investigative Site | Columbus | Georgia | 31904 | United States |
| Novartis Investigative Site | Savannah | Georgia | 31406 | United States |
| Novartis Investigative Site | Evansville | Indiana | 47713 | United States |
| Novartis Investigative Site | Topeka | Kansas | 66606 | United States |
| Novartis Investigative Site | Cynthiana | Kentucky | 41031 | United States |
| Novartis Investigative Site | Metarie | Louisiana | 70002 | United States |
| Novartis Investigative Site | Burlington | Massachusetts | 01801 | United States |
| Novartis Investigative Site | Kalamazoo | Michigan | 49008 | United States |
| Novartis Investigative Site | Stevensville | Michigan | 49127 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Novartis Investigative Site | Plymouth | Minnesota | 55441 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39202 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63104 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 16945 | United States |
| Novartis Investigative Site | Berkeley Heights | New Jersey | 07922 | United States |
| Novartis Investigative Site | Brick | New Jersey | 08724 | United States |
| Novartis Investigative Site | Summit | New Jersey | 07901 | United States |
| Novartis Investigative Site | West Orange | New Jersey | 07052 | United States |
| Novartis Investigative Site | Batavia | New York | 14020 | United States |
| Novartis Investigative Site | Brooklyn | New York | 11229 | United States |
| Novartis Investigative Site | Rockville Centre | New York | 11570 | United States |
| Novartis Investigative Site | High Point | North Carolina | 27262 | United States |
| Novartis Investigative Site | Toledo | Ohio | 43604 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | United States |
| Novartis Investigative Site | Gresham | Oregon | 97030 | United States |
| Novartis Investigative Site | Allentown | Pennsylvania | 18104 | United States |
| Novartis Investigative Site | Altoona | Pennsylvania | 16601 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Novartis Investigative Site | Providence | Rhode Island | 02906 | United States |
| Novartis Investigative Site | Kingsport | Tennessee | 37660 | United States |
| Novartis Investigative Site | Dallas | Texas | 75230 | United States |
| Novartis Investigative Site | Houston | Texas | 77054 | United States |
| Novartis Investigative Site | Murray | Utah | 84107 | United States |
| Novartis Investigative Site | South Burlington | Vermont | 05403 | United States |
| Novartis Investigative Site | Emporia | Virginia | 23847 | United States |
| Novartis Investigative Site | Norfolk | Virginia | 23507 | United States |
| Novartis Investigative Site | Bellingham | Washington | 98225 | United States |
| Novartis Investigative Site | Madison | Wisconsin | 53715 | United States |
| Novartis Investigative Site | San Juan | 00917 | Puerto Rico |