Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00252135
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00252135
Study Brief:
Protocol Section:
NCT00252135