Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (X-PAND)

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Drug: Xolair

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • Investigational Site
  • Florida
    • Valrico, Florida, United States, 33596
      • Investigational Site
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Investigational Site
  • New York
    • New York, New York, United States, 10022
      • Investigational Site
  • Pennsylvania
    • Blue Bell, Pennsylvania, United States, 19422
      • Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Abdelkader Rahmaoui, M.D., Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2009
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 22, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (Estimate): December 23, 2008

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Asthma; Anaphylaxis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: Q4458g