Phase 2 N=55 Randomized Double-blind Treatment

Oral Immunotherapy for Childhood Egg Allergy

Hypersensitivity · Immediate Hypersensitivity · Food Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT00461097 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

May 2012

Primary outcome: Primary: Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg — 27.5; 0 percentage of participants — p=0.025

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Egg oral immunotherapy (Drug); Control Group (Drug)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg	27.5; 0	0.025 sig
SECONDARY Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid	55.0; 0.0	—
SECONDARY Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation	22.5; 86.7	—
SECONDARY Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg	45.0; 80.0	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs)	3; 0	—
SECONDARY Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid	52.5	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Convincing clinical history of egg allergy
Age 6 to 18 years, with a serum IgE [UniCAP] to egg > 5 kUA/L OR
Age 5 to 6 years, with a serum IgE [UniCAP] to egg ≥ 12kUA/L
Parent/guardian willing to provide informed consent
Willing to use acceptable forms of contraception

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 6 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00461097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.