An observational study in Allergic Asthma, sponsored by Genentech, Inc.. Completed at 7 sites in United States. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Genentech, Inc. · Observational
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.
88 studies on the registry are indexed under Anaphylaxis; 16 are open to participants now.
This study's enrollment of 118 is below the median of 147 across 45 observational studies indexed under Anaphylaxis.
Browse Anaphylaxis studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
primary care clinic
Inclusion Criteria for Cases:
Inclusion Criteria for Controls:
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.
Time frame: Baseline (Enrollment Visit)
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Enrollment Visit)
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
Time frame: Baseline (Enrollment Visit)
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
Time frame: 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.
Time frame: Baseline (Enrollment Visit)
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Enrollment Visit)
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
Time frame: 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.
Time frame: Substudy Week 10
| Milestone | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Started | 30 | 88 |
| Completed | 30 | 88 |
| Not completed | 0 | 0 |
| Milestone | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Started | 3 | 8 |
| Completed | 3 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
| participants | Omalizumab Cases |
|---|---|
| Cutaneous/Subcutaneous/Mucosal + R | 24 |
| Cutaneous/Subcutaneous/Mucosal + R + CV | 2 |
| Cutaneous/Subcutaneous/Mucosal + R + GIT | 1 |
| Cutaneous/Subcutaneous/Mucosal + CV | 1 |
| R + CV + GIT | 1 |
| CV | 1 |
| minutes | Omalizumab Cases |
|---|---|
| Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants | 30 (0 to 210) |
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.
| participants | Omalizumab Cases |
|---|---|
| <30 minutes | 13 |
| 30-60 minutes | 8 |
| >60-90 minutes | 3 |
| >90-120 minutes | 2 |
| >120-360 minutes | 1 |
| Missing | 3 |
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.
| participants | Omalizumab Cases |
|---|---|
| 1 Dose | 6 |
| 2 Doses | 3 |
| 3 Doses | 2 |
| 4-20 Doses | 8 |
| 21-40 Doses | 4 |
| 41-60 Doses | 4 |
| >60 Doses | 1 |
| Missing | 2 |
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.
| participants | Omalizumab Cases |
|---|---|
| Antihistamine | 23 |
| Epinephrine | 21 |
| Inhaled Beta Agonists | 13 |
| Systemic Corticosteroids | 19 |
| Other | 6 |
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.
| participants | Omalizumab Cases |
|---|---|
| Life-Threatening | 12 |
| In-Patient Hospitalization or its Prolongation | 6 |
| Other | 12 |
| participants | Omalizumab Cases |
|---|---|
| Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants | 4 |
| participants | Omalizumab Cases |
|---|---|
| Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants | 7 |
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.
| participants | Omalizumab Cases |
|---|---|
| Antihistamine | 4 |
| Epinephrine | 2 |
| Inhaled Beta Agonists | 3 |
| Systemic Corticosteroids | 1 |
| Other | 1 |
| participants | Omalizumab Cases |
|---|---|
| Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants | 3 |
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.
| participants | Omalizumab Cases |
|---|---|
| Antihistamine | 1 |
| Epinephrine | 1 |
| Inhaled Beta Agonists | 1 |
| Systemic Corticosteroids | 1 |
| Other | 1 |
Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
| participants | Omalizumab Cases |
|---|---|
| 5-Hydroxytryptamine Receptor 1 (5-HT1) Agonists | 1 |
| Adrenergics/Sympathomimetics | 3 |
| Aminoglycoside Antimicrobials | 1 |
| Analgesic/Other Drug Combinations | 2 |
| Analgesics | 4 |
| Angiotensin II Receptor Antagonists | 2 |
| Antacids NEC | 1 |
| Antianxiety Agents | 1 |
| Antidepressants NEC | 1 |
| Antidiuretics | 1 |
| Antiemetics NEC | 2 |
| Antihistamines | 16 |
| Antipsychotic and Antimanic Agents | 2 |
| Benzodiazepines | 6 |
| Biguanides | 1 |
| Bisphosphonates | 1 |
| Bronchodilators and Antiasthmatics | 29 |
| Calcium Channel Blocking Agents | 3 |
| Cephalosporin Antibiotics | 1 |
| Cough Preparations | 2 |
| Diuretics NEC | 1 |
| Glycopeptide Antibiotics | 1 |
| Herbal,Homeopathic,& Dietary Supplements | 1 |
| Histamine H2-receptor Antagonists | 3 |
| Laxatives and Stool Softeners | 1 |
| Leukotriene Receptor Antagonists | 21 |
| Macrolide Antibiotics | 2 |
| Miscellaneous Gastrointestinal Agents | 1 |
| Muscle Relaxants | 1 |
| Non-steroidal Anti-inflammatories | 2 |
| Opioid Analgesics | 1 |
| Penicillins | 1 |
| Peripheral and Cerebral Vascular Agents | 1 |
| Proton Pump Inhibitors | 10 |
| Salicylates | 1 |
| Sedatives and Hypnotics | 1 |
| Selective Serotonin Re-uptake Inhibitors | 4 |
| Sex Hormones | 3 |
| Statins | 2 |
| Steroid/Other Drug Combinations | 1 |
| Steroids | 22 |
| Supplements | 2 |
| Thiazide Diuretics | 1 |
| Thyroid Hormones | 4 |
| Tricyclic Antidepressants | 4 |
| Vitamins and Minerals | 2 |
Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
| participants | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| 5-HT1 Agonists | 0 | 2 |
| 5-Hydroxytryptamine Receptor 3 (5-HT3) Antagonists | 1 | 0 |
| Adrenergics/Sympathomimetics | 2 | 0 |
| Alpha-adrenoreceptor Antagonists | 2 | 4 |
| Aminoglycoside Antimicrobials | 0 | 1 |
| Aminosalicylates | 0 | 1 |
| Analgesic/Other Drug Combinations | 3 | 5 |
| Analgesics | 5 | 11 |
| Androgens and Anabolic Steroids | 0 | 3 |
| Angiotensin II Receptor Antagonists | 5 | 6 |
| Angiotensin-converting Enzyme Inhibitors | 1 | 6 |
| Anorexiants and CNS Stimulants | 2 | 6 |
| Antacids NEC | 0 | 1 |
| Antiallergic Agents NEC | 0 | 1 |
| Antiandrogens | 0 | 2 |
| Antianemic Agents | 0 | 2 |
| Antianginal Agents NEC | 0 | 1 |
| Antianxiety Agents | 1 | 2 |
| Anticoagulants | 0 | 4 |
| Anticonvulsants NEC | 3 | 12 |
| Antidepressants NEC | 1 | 10 |
| Antidiuretics | 1 | 0 |
| Antiemetics NEC | 2 | 4 |
| Antifungal Agents | 0 | 1 |
| Antiglaucoma Agents | 0 | 1 |
| Antigout Agents | 0 | 5 |
| Antihistamines | 19 | 57 |
| Antihypertensive Agents NEC | 2 | 9 |
| Antimalarial Agents | 0 | 1 |
| Antimetabolites | 0 | 2 |
| Antimicrobial/Other Drug Combinations | 0 | 1 |
| Antiparkinsonism Agents NEC | 0 | 1 |
| Antipsychotic and Antimanic Agents | 3 | 3 |
| Antispasmodics and Anticholinergics | 5 | 1 |
| Antitrichomonal Agents | 1 | 1 |
| Antiviral Agents NEC | 0 | 1 |
| Benzodiazepines | 9 | 10 |
| Beta-adrenoceptor Blocking Agents | 2 | 4 |
| Biguanides | 1 | 5 |
| Bisphosphonates | 1 | 3 |
| Bronchodilators and Antiasthmatics | 27 | 70 |
| Calcium Channel Blocking Agents | 6 | 12 |
| Calcium Compounds and Regulators | 4 | 7 |
| Cephalosporin Antibiotics | 0 | 1 |
| Cold and Sinus Remedies | 1 | 3 |
| Cough Preparations | 0 | 5 |
| Cox-2 Inhibitors | 1 | 2 |
| Dermatologic Agents | 1 | 2 |
| Diuretics NEC | 0 | 6 |
| Dopaminergic Agents | 2 | 0 |
| Enzymes | 0 | 1 |
| Fibrates | 0 | 2 |
| Folic Acid and Derivatives | 1 | 2 |
| Herbal,Homeopathic,& Dietary Supplements | 4 | 16 |
| Histamine H2-receptor Antagonists | 5 | 6 |
| Hypertensives | 1 | 0 |
| Hypoglycemics NEC | 1 | 3 |
| Immunosuppressants | 1 | 2 |
| Insulins | 0 | 2 |
| Laxatives and Stool Softeners | 1 | 3 |
| Leukotriene Receptor Antagonists | 19 | 49 |
| Lipid Regulating Agents NEC | 0 | 2 |
| Local Anesthetics | 1 | 0 |
| Loop Diuretics | 2 | 9 |
| Macrolide Antibiotics | 3 | 2 |
| Miscellaneous Cardiovascular Agents | 0 | 1 |
| Miscellaneous Drugs | 0 | 1 |
| Mucosal Protectants | 1 | 0 |
| Muscle Relaxants | 2 | 6 |
| Nitrofurans | 0 | 1 |
| Non Drug Therapies | 1 | 1 |
| Non-steroidal Anti-inflammatories | 6 | 9 |
| Opioid Analgesics | 2 | 6 |
| Parasympathomimetics and Antimyasthenics | 1 | 0 |
| Penicillins | 1 | 2 |
| Peripheral and Cerebral Vascular Agents | 1 | 0 |
| Pharmaceutic Aids | 1 | 2 |
| Pharmacotherapeutic Class (ES) Not Known | 0 | 3 |
| Phenothiazines | 1 | 0 |
| Platelet Aggregation Inhibitors | 0 | 3 |
| Proton Pump Inhibitors | 13 | 36 |
| Quinolone Antibiotics | 0 | 3 |
| Salicylates | 4 | 12 |
| Sedatives and Hypnotics | 2 | 5 |
| Selective Serotonin Re-uptake Inhibitors | 8 | 15 |
| Sex Hormones | 8 | 14 |
| Statins | 3 | 20 |
| Steroid/Other Drug Combinations | 0 | 3 |
| Steroids | 24 | 53 |
| Sulfonylureas | 2 | 1 |
| Supplements | 1 | 12 |
| Tetracyclines | 1 | 0 |
| Therapeutic Gases | 2 | 2 |
| Thiazide Diuretics | 3 | 3 |
| Thiazolidinediones | 0 | 2 |
| Thyroid Hormones | 5 | 12 |
| Tricyclic Antidepressants | 3 | 4 |
| Vaccines, Toxoids and Serologic Agents | 1 | 1 |
| Vitamins and Minerals | 9 | 24 |
Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.
| participants | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Participants with Positive IgG ATA | 0 | 0 |
| Participants with Negative IgG ATA | 21 | 10 |
| Participants with Positive IgE ATA | 0 | 0 |
| Participants with Negative IgE ATA | 21 | 10 |
| participants | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy | 0 | 2 |
Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
| participants | Omalizumab Cases | Omalizumab Controls |
|---|---|---|
| Participants with Positive IgG ATA | 0 | 0 |
| Participants with Negative IgG ATA | 3 | 6 |
| Participants with Positive IgE ATA | 0 | 0 |
| Participants with Negative IgE ATA | 3 | 6 |
Collected over Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observational Study: Omalizumab Cases - With Anaphylaxis | — | 0/30 (0%) | 0/30 (0%) |
| Observational Study: Omalizumab Controls - Without Anaphylaxis | — | 0/88 (0%) | 0/88 (0%) |
| Skin Test Substudy: Omalizumab Cases - With Anaphylaxis | — | 1/3 (33.3%) | 1/3 (33.3%) |
| Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis | — | 0/7 (0%) | 1/7 (14.3%) |
| Event | Observational Study: Omalizumab Cases - With Anaphylaxis | Observational Study: Omalizumab Controls - Without Anaphylaxis | Skin Test Substudy: Omalizumab Cases - With Anaphylaxis | Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis |
|---|---|---|---|---|
| Status asthmaticusRespiratory, thoracic and mediastinal disorders | 0/30 | 0/88 | 1/3 | 0/7 |
| Event | Observational Study: Omalizumab Cases - With Anaphylaxis | Observational Study: Omalizumab Controls - Without Anaphylaxis | Skin Test Substudy: Omalizumab Cases - With Anaphylaxis | Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis |
|---|---|---|---|---|
| HeadacheNervous system disorders | 0/30 | 0/88 | 1/3 | 0/7 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/30 | 0/88 | 0/3 | 1/7 |
All enrolled participants.
| Age, Continuous(years) | Omalizumab Cases | Omalizumab Controls | Total |
|---|---|---|---|
| Mean | 42.7 ± 16.41 | 45.4 ± 15.40 | 44.7 ± 15.64 |
| Sex: Female, Male(Participants) | Omalizumab Cases | Omalizumab Controls | Total |
|---|---|---|---|
| Female | 27 | 60 | 87 |
| Male | 3 | 28 | 31 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.