Status:
COMPLETED
Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
Lead Sponsor:
Hugh A Sampson, MD
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Consortium of Food Allergy Research
Conditions:
Food Allergy
Eligibility:
All Genders
3-16 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.
Detailed Description
Food allergy affects 6-8 percent of children in the United States. In young children, reactions to egg can range from hives to severe life threatening allergic reactions called anaphylaxis. Current tr...
Eligibility Criteria
Inclusion
- Age 3 through 16 years with a serum IgE to egg of \>= 5 kUA/L within the past 12 months\]
- Reacting to the initial baked egg OFC with dose limiting symptoms OR
- Reacting on a 2 gm egg OFC with dose limiting symptoms to a cumulative dose of 2 gm or less after passing the initial baked egg OFC
- Written informed consent from subject and/or parent/guardian
- Written assent from all subjects as appropriate
- All females of child bearing age must be using appropriate birth control
Exclusion
- History of anaphylaxis to egg resulting in hypotension, neurological compromise or mechanical ventilation
- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Active eosinophilic gastrointestinal disease in the past 2 years
- Participation in any interventional study for the treatment of food allergy in the past 6 months
- Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
- Severe asthma, or uncontrolled mild or moderate asthma. More information on these exclusion criteria can be found in the protocol.
- Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy (e.g. infliximab, rituximab, etc.) within the past year
- Use of Beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- Use of investigational drug within 90 days or plan to use investigational drug during the study period
- Pregnancy or lactation
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01846208
Start Date
July 1 2013
End Date
September 30 2018
Last Update
July 26 2019
Active Locations (5)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
National Jewish Health
Denver, Colorado, United States, 80206
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 100029