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

Study Overview
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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.

Official Title
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Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: Xolair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Cases: Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair Inclusion Criteria for Controls: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xolair|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants | Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms. | Baseline (Enrollment Visit) | 
| Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants |  | Baseline (Enrollment Visit) | 
| Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported. | Baseline (Enrollment Visit) | 
| Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants | Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported. | Baseline (Enrollment Visit) | 
| Treatment Received Following Adjudicated Anaphylactic Event - Case Participants | Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment. | Baseline (Enrollment Visit) | 
| Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants | Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported. | Baseline (Enrollment Visit) | 
| Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants |  | Baseline (Enrollment Visit) | 
| Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants |  | Baseline (Enrollment Visit) | 
| Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants | Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment. | Baseline (Enrollment Visit) | 
| Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants |  | Baseline (Enrollment Visit) | 
| Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants | Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment. | Baseline (Enrollment Visit) | 
| Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants | Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified. | Baseline (Enrollment Visit) | 
| Medications Within Two Weeks Prior to Blood Draw | Number of participants in each medication class is reported. Participants could have received more than 1 medication class. | Baseline (Enrollment Visit) | 
| Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study | Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported. | Baseline (Enrollment Visit) | 
| Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy |  | Substudy Day 1 | 
| Number of Participants With ATA - Skin Testing Substudy | Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported. | Substudy Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Anaphylaxis