Baked Egg or Egg Oral Immunotherapy for Children With Egg Allergy

NCT ID: NCT01846208

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-09-30

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.

Conditions

Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Egg OIT Randomized

Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.

Group Type: EXPERIMENTAL

Egg Oral Immunotherapy

Intervention Type: DRUG

Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Baked Egg Randomized

Subjects who passed a baked egg oral food challenge (OFC) at baseline were randomized to receive baked egg in the form of home-baked goods and "safe" commercial products with up to four oral food challenges as directed by the protocol.

Group Type: EXPERIMENTAL

Baked Egg

Intervention Type: DRUG

Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

Egg OIT Assigned

Subjects who failed a baked egg oral food challenge (OFC) at baseline were assigned to receive egg oral immunotherapy (OIT) in the form of egg white solid with up to four oral food challenges as directed by protocol.

Group Type: EXPERIMENTAL

Egg Oral Immunotherapy

Intervention Type: DRUG

Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Interventions

Egg Oral Immunotherapy

Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Intervention Type: DRUG

Baked Egg

Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.

Intervention Type: DRUG

Other Intervention Names

Egg white solid

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.
• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Consortium of Food Allergy Research

OTHER

Sponsor Role: collaborator

Hugh A Sampson, MD

OTHER

Sponsor Role: lead

Responsible Party

Hugh A Sampson, MD

Director, Jaffe Food Allergy Institute

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hugh A Sampson, MD

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Robert Wood, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

National Jewish Health

Denver, Colorado, United States

Johns Hopkins University

Baltimore, Maryland, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

http://www.cofargroup.org

Study Web Site

Other Identifiers

U19AI066738

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CoFAR7

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 04-1271

Identifier Type: -

Identifier Source: org_study_id