A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
Information source: Genentech
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Genentech Official(s) and/or principal investigator(s):
June Lee, M.D., Study Director, Affiliation: Genentech
Summary
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.
Clinical Details
Official title: An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS)
Study design: Natural History, Longitudinal, Defined Population, Prospective Study
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2004
Last updated: November 9, 2006
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