Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
NCT ID: NCT01362621
Last Updated: 2011-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
474 participants
OBSERVATIONAL
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children 6 to less than 12 years of age
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
* Documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific IgE test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
* Prescribed inhaled corticosteroid for at least 3 months prior to screening (A) and having evidence of inadequately controlled disease either with at least one from list (B) OR history of asthma-related exacerbations as defined in (C). \[e.g., A and (B or C)\]
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:
* on average asthma symptoms \> 2 days/week or multiple times in a day on ≤ 2 days/week
* nighttime awakenings ≥ 2 times/month due to asthma symptoms
* use of SABAs \> 2 times/week on average
* some limitation in activity due to asthma
* on spirometric evaluation, FEV1 ≤ 80% of predicted, FEV1/FVC ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best
C. Minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit
Exclusion Criteria
* Subjects with a history of prior use of omalizumab
* Subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
* Subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
* Subjects with elevated serum IgE levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich Syndrome
6 Years
11 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Crescent City, California, United States
Novartis Investigative Site
Fresno, California, United States
Novartis Investigative Site
Oakland, California, United States
Novartis Investigative Site
Orange, California, United States
Novartis Investigative Site
Roseville, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Walnut Creek, California, United States
Novartis Investigative Site
Thornton, Colorado, United States
Novartis Investigative Site
Albany, Georgia, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Columbus, Georgia, United States
Novartis Investigative Site
Savannah, Georgia, United States
Novartis Investigative Site
Evansville, Indiana, United States
Novartis Investigative Site
Topeka, Kansas, United States
Novartis Investigative Site
Cynthiana, Kentucky, United States
Novartis Investigative Site
Metarie, Louisiana, United States
Novartis Investigative Site
Burlington, Massachusetts, United States
Novartis Investigative Site
Kalamazoo, Michigan, United States
Novartis Investigative Site
Stevensville, Michigan, United States
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Minneapolis, Minnesota, United States
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Plymouth, Minnesota, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
Novartis Investigative Site
Berkeley Heights, New Jersey, United States
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Brick, New Jersey, United States
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Summit, New Jersey, United States
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West Orange, New Jersey, United States
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Batavia, New York, United States
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Brooklyn, New York, United States
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Rockville Centre, New York, United States
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High Point, North Carolina, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Gresham, Oregon, United States
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Allentown, Pennsylvania, United States
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Altoona, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Kingsport, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Murray, Utah, United States
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South Burlington, Vermont, United States
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Emporia, Virginia, United States
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Norfolk, Virginia, United States
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Bellingham, Washington, United States
Novartis Investigative Site
Madison, Wisconsin, United States
Novartis Investigative Site
San Juan, , Puerto Rico
Countries
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Other Identifiers
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CIGE025BUS26
Identifier Type: -
Identifier Source: org_study_id
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