Oral Immunotherapy for Childhood Egg Allergy - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Consortium of Food Allergy Research
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00461097

Purpose

The purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg.

Condition	Intervention
Hypersensitivity Immediate Hypersensitivity Food Hypersensitivity	Drug: Oral egg immunotherapy Drug: Placebo for egg white solid

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Oral Desensitization to Egg With Subsequent Induction of Tolerance for Egg-Allergic Children

Resource links provided by NLM:

MedlinePlus related topics: Allergy Food Allergy

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Percent of participants who can tolerate 10,000 mg of egg white solid [ Time Frame: Between 4 to 6 weeks after discontinuing egg oral immunotherapy (OIT) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of participants who consume without symptoms 5,000 mg of egg white solid [ Time Frame: Following the desensitization phase of the study ] [ Designated as safety issue: No ]
Percent of participants who successfully complete the initial escalation to 50 mg of egg white solid OIT [ Time Frame: During the first 32 weeks of the study ] [ Designated as safety issue: No ]
Percent of participants who achieve the 2,000 mg dose of egg white solid OIT [ Time Frame: During the desensitization phase of the study ] [ Designated as safety issue: No ]
Incidence of all serious adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	55
Study Start Date:	May 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Oral egg immunotherapy (in the form of egg white solid) and up to four oral food challenges as directed by the protocol	Drug: Oral egg immunotherapy Egg white solid powder
2: Placebo Comparator Placebo for egg white solid and up to four oral food challenges as directed by the protocol	Drug: Placebo for egg white solid Placebo powder

Detailed Description:

In the United States, as many as 6% to 8% of children are affected by food allergy. In young children, allergic reactions to egg can range from mild rash to systemic anaphylaxis. The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine. 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 standard injection (under the skin) immunotherapy for food allergy is associated with a high rate of allergic reactions, a few studies have recently tried OIT in food allergy. The purpose of this study is to determine the safety and efficacy of the administration of OIT. The intent is to develop desensitization and eventually tolerance to egg allergen. This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time.

This study will last up to 22 months. The participants will be randomly assigned to receive treatment with egg white solid or placebo. This study will include dose escalation followed by oral food challenge (OFC). Visit 1 consists of multiple small incremental doses of egg white solid. This is followed by 32 weeks of gradual dose escalation to a stable maintenance dose of egg white solid. Around Week 40, participants will be given an OFC using egg white solid to identify desensitized individuals. Participants and study staff will be unblinded following this initial OFC. Maintenance therapy is continued for an additional year. An end of study OFC challenge will be performed to test for desensitization. If passed, a repeat OFC off therapy will be performed to test for tolerance.

Participants receiving placebo during dose escalation are given the OFC at 40 weeks. They will be unblinded at that time and continue on an egg-restricted diet until the end of the study.

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

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Convincing clinical history of egg allergy
Serum IgE [UniCAP] to egg of greater than 5 kU/l
Parent/guardian willing to provide informed consent
Willing to use acceptable forms of contraception
Age 5 to 6 years, with a serum IgE [UniCAP] 12kU/L

Exclusion Criteria:

History of severe anaphylaxis to egg. More information on this criterion can be found in the protocol.
Known allergy to corn
Chronic disease requiring therapy (e.g., heart disease, diabetes). Participants who have asthma, atopic dermatitis, or rhinitis are not excluded.
Participation in any interventional study for the treatment of food allergy in the 12 months prior to study entry
Participant is on "build-up phase" of immunotherapy and has not reached maintenance dosing. Participants tolerating maintenance allergen immunotherapy are not excluded.
Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
Inability to discontinue antihistamines for the initial day of escalation, skin testing, and OFC
Omalizumab or other nontraditional forms of oral or sublingual allergen immunotherapy, immunomodulator therapy, or biologic therapy in the 12 months prior to study entry. Participants who have taken corticosteroids are not excluded.
Investigational drugs 90 days prior to study entry or planned use of an investigational drug during the study period
Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461097

Locations

United States, Arkansas
University of Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 22708

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Consortium of Food Allergy Research

Investigators

Study Chair:	Wesley Burks, MD	Duke University
Study Chair:	Stacie Jones, MD	Allergy/Immunology Department, Arkansas Children's Hospital
Principal Investigator:	Robert Wood, MD	Johns Hopkins University
Principal Investigator:	Scott Sicherer, MD	Mount Sinai School of Medicine
Principal Investigator:	David Fleischer, MD	National Jewish Health

More Information

Publications:

Baral VR, Hourihane JO. Food allergy in children. Postgrad Med J. 2005 Nov;81(961):693-701. Review.

Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. Review.

Wood RA. The natural history of food allergy. Pediatrics. 2003 Jun;111(6 Pt 3):1631-7. Review.

Responsible Party:	DAIT/NIAID ( Associate Director, Clinical Research Prgoram )
Study ID Numbers:	DAIT COFAR3, COFAR
Study First Received:	April 16, 2007
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00461097 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Egg Allergy
Egg Oral Immunotherapy
Food Allergy

Additional relevant MeSH terms:

Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Egg Hypersensitivity

ClinicalTrials.gov processed this record on November 22, 2009