Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-01-31

Brief Summary

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This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.

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Detailed Description

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Conditions

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Allergic Asthma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Xolair

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair

* At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment
* At least one dose of Xolair in the 18 months before the date of the case event (index date)
* No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components

Eligible Sex

ALL

Accepts Healthy Volunteers

No