Registry of Food Allergy Oral Immunotherapy Treatment

Food Allergy Clinical Trial

Official title:

National Registry of Food Allergy Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059589
• Other study ID #: Mylan-16-004
• Status: Completed
• Start date: April 15, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Food Allergy Support Team
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.

Description:

Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 31, 2020
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food,

• no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food

Exclusion Criteria:

• pregnancy

• severe asthma

• poorly controlled atopic dermatitis

• eosinophilic esophagitis

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
United States	Food Allergy Center of FL	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Food Allergy Support Team

Country where clinical trial is conducted

United States, 

References & Publications (2)

Nachshon L, Goldberg MR, Elizur A, Levy MB, Schwartz N, Katz Y. A Web site-based reporting system for monitoring home treatment during oral immunotherapy for food allergy. Ann Allergy Asthma Immunol. 2015 Jun;114(6):510-5. doi: 10.1016/j.anai.2015.04.007. Epub 2015 May 1. — View Citation

Wasserman RL, Factor JM, Baker JW, Mansfield LE, Katz Y, Hague AR, Paul MM, Sugerman RW, Lee JO, Lester MR, Mendelson LM, Nacshon L, Levy MB, Goldberg MR, Elizur A. Oral immunotherapy for peanut allergy: multipractice experience with epinephrine-treated reactions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):91-6. doi: 10.1016/j.jaip.2013.10.001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of food allergy treatment	the percentage of patients who successfully reach the maintenance dose of food	3 years
Secondary	epinephrine use	The frequency of epinephrine use during the course of oral immunotherapy as reported in the prospective database. Also, identify factors that are associated with the need for epinephrine.	3 years
Secondary	factors associated with the failure to reach the target dose of food ingestion	Identify factors that are associated with treatment failures through analysis of patient demographics, baseline laboratory test results, and concomitant atopic conditions.	3 years