Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy (NCT01846208) | Clinical Trial Compass
CompletedPhase 2
Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
United States92 participantsStarted 2013-07
Plain-language summary
The purpose of this study is to compare Baked Egg vs. Egg Oral Immunotherapy for inducing sustained unresponsiveness to egg exposure in children.
Who can participate
Age range3 Years – 16 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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. inf…
What they're measuring
1
Sustained Unresponsiveness to Egg Consumption at 2 Years.