A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients will be recruited from a variety of practice settings, including managed care organizations, community physicians, and academic centers.
Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
≥12 years of age
Physician diagnosis of moderate to severe persistent asthma
Evidence or history of positive skin test or in vitro reactivity to an aeroallergen
Willingness to participate fully for the duration of the study (5 years)
For patients in the Xolair-treated cohort, have received at least one dose of Xolair therapy at the time of enrollment
Contraindication to Xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to Xolair)
Acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
Acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
Use of an experimental drug within 30 days prior to study screening
Diagnosis of cystic fibrosis
For patients in the non-Xolair-treated cohort, any prior treatment with Xolair