Hypersensitivity Clinical Trial
Official title:
Oral Desensitization to Egg With Subsequent Induction of Tolerance for Egg-Allergic Children (CoFAR 3)
Verified date | November 2017 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | December 2013 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | University of North Carolina | Chapel Hills | North Carolina |
United States | National Jewish Medical and Research Center | Denver | Colorado |
United States | University of Arkansas Children's Hospital Research Institute | Little Rock | Arkansas |
United States | Mount Sinai School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Consortium of Food Allergy Research |
United States,
Baral VR, Hourihane JO. Food allergy in children. Postgrad Med J. 2005 Nov;81(961):693-701. Review. — View Citation
Burks AW, Jones SM, Wood RA, Fleischer DM, Sicherer SH, Lindblad RW, Stablein D, Henning AK, Vickery BP, Liu AH, Scurlock AM, Shreffler WG, Plaut M, Sampson HA; Consortium of Food Allergy Research (CoFAR). Oral immunotherapy for treatment of egg allergy i — View Citation
Sicherer SH, Sampson HA. 9. Food allergy. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S470-5. Review. — View Citation
Wood RA. The natural history of food allergy. Pediatrics. 2003 Jun;111(6 Pt 3):1631-7. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of Participants Who Successfully Consumed 10,000 mg of Egg White Solid Followed by Open Feeding of Egg | Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were then given an open feeding of egg and those who successfully consumed the open feeding of egg were counted as successes. | At the 2 year time point; Egg OIT participants must be approximately 4-6 weeks post-discontinuation of therapy | |
Secondary | Percent of Participants Who Successfully Consumed 5,000 mg of Egg White Solid | Desensitization assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of egg white solid during a double-blind placebo-controlled oral food challenge were counted as successes. | Following the blinded desensitization phase at approximately Week 44 | |
Secondary | Percent of Participants Who Successfully Consumed a 50 mg Dose at Initial Escalation | On the initial day of dosing, participants were offered 0.1 mg of egg white solid or placebo followed by an approximate doubling every 30 minutes up to a 50 mg dose providing limiting reactions do not occur. | Initial day of dosing | |
Secondary | Percent of Participants Who Achieved a Maintenance Dose of 2,000 mg | For participants whose maximum tolerated dose on the initial escalation day was less than 50 mg, doses were doubled every 2 weeks up to 50 mg. After 50 mg, dosing was increased to 75 mg, and then dosing increased by 25% until the 2000 mg dose was reached. The maximum time allowed for the build-up phase was 40 weeks; the dose achieved at 40 weeks was considered the maintenance dose. | Following the blinded desensitization phase at approximately Week 44 | |
Secondary | Number of Participants With Serious Adverse Events (SAEs) | This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3. | Baseline through the 2-year primary endpoint | |
Secondary | Percent of Participants in the Egg OIT Treatment Arm Who Successfully Consumed 10,000 mg of Egg White Solid | Tolerance Assessment: Participants in the Egg OIT treatment arm who were not tolerant at 2 years were offered an additional 2 years of therapy. A 10,000 mg double-blind placebo controlled oral food challenge to egg was done the same way as the one performed at 2 years for these participants in order to identify tolerant individuals in the 2 to 4 year extension segment. The tolerant individuals from this segment were then added to the tolerant individuals from the 2 year segment. | 4 years (48 months) |
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