Status:
COMPLETED
A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
Lead Sponsor:
Genentech, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
8023 Patients enrolled
Trial Details
Trial ID
NCT00252135
Start Date
June 1 2004
End Date
November 1 2011
Last Update
May 12 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.