A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma

Completed

• Conditions: Asthma

• Registration Number: NCT00252135
• Lead Sponsor: Genentech, Inc.

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 or in vitro reactivity to an aeroallergen.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8023

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified