Clinical trial NCT01846208: Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy
Official title: Oral Desensitization to Egg With Subsequent Induction of Sustained Unresponsiveness for Egg-Allergic Children Using Baked Egg or Egg Oral Immunotherapy (OIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Food Allergy
Keywords: Egg Allergy
Egg Oral Immunotherapy
Food Allergy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Consortium of Food Allergy Research
First posted: 2013-05-03
Enrollment: 92
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The purpose of this study is to compare baked foods with egg versus (vs.) egg OIT. The intent of the study is to investigate if participants will be able to consume egg after taking baked foods with egg or egg OIT for a period of time and then stopping for a certain period. This is referred to as tolerance or sustained unresponsiveness. This study will evaluate the effectiveness of the egg OIT vs. baked egg by having each participant ingest egg white solid or baked foods with egg. This will be done over 2 years.

This study will last 2 years. All eligible subjects will receive a baked egg oral food challenge (OFC). Those who pass the baked egg OFC will then have a 2 gm egg OFC. Those who react to the egg OFC will be randomized to Baked Egg or Egg OIT. Individuals who do not pass the initial baked egg OFC will be assigned to Egg OIT. Those who pass the egg OFC will not be eligible for the study and will be followed per site standard of care. All eligible and enrolled subjects will have a 1-year and a 2-year OFC.

At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

Eligibility criteria: 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. 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

Primary outcomes:
measure: Sustained Unresponsiveness to Egg Consumption at 2 Years.
timeFrame: 2 Years
Secondary outcomes:
measure: Desensitization to >= 4.444 Grams Egg White Solid.
timeFrame: 1 Year and 2 Years
measure: Incidence of All Serious Adverse Events
timeFrame: up to 3 years
measure: Number of Participants With Unrestricted Consumption of Unbaked Egg
timeFrame: 3 years after randomization
Other outcomes:
measure: Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results.
timeFrame: 2 Years
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Hugh A Sampson, MD
role: STUDY_CHAIR
affiliation: Johns Hopkins University
name: Robert Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: