Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma

Completed

Conditions studied: Moderate to Severe Allergic Asthma

In brief

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.

Key facts

Study ID

NCT01362621

Run by

Novartis Pharmaceuticals

People needed

474

Starts

2008-02-01

Last updated by the study team

2011-06-16

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Total IgE ≥30 IU (historical values obtained within 3 months of screening visit will be accepted). If historic result not available, to be obtained at screening visit.
• 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

You may not qualify if…

• Subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of Visit 1 or a biologic agent within 120 days of Visit 1
• 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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Plymouth, Minnesota, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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