Overview

This trial is active, not recruiting.

Condition peanut allergy
Treatments peanut protein, oat flour
Phase phase 1
Sponsor Hamilton Health Sciences Corporation
Collaborator AllerGen NCE Inc.
Start date February 2012
End date December 2015
Trial size 50 participants
Trial identifier NCT01601522, REB 07-348

Summary

The purpose of the study is to determine how a type of treatment for peanut allergy known as oral desensitization works in the immune system.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
500 mg Peanut Protein
peanut protein Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour
500 mg
(Placebo Comparator)
Oat flour
oat flour
500 mg Oat flour

Primary Outcomes

Measure
Ability to tolerate peanut
time frame: 6 months

Secondary Outcomes

Measure
Lessening of side effects compared to placebo
time frame: 6 months
Immunological changes driving the desensitization/tolerance process
time frame: 6 months
Quality of life pre and post OIT will be done.
time frame: 6 months

Eligibility Criteria

Male or female participants from 5 years up to 10 years old.

Inclusion Criteria: - Patients must be between 5 and 10 years of age. - Patients will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes after the ingestion of peanut,the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control; and a positive in vitro IgE [CAP-FEIA] result of >15 kU/L.. - Patients will also be accepted into the study if they have a clinical reaction to peanut ingestion within the past 6 months, a positive skin prick test to peanut as defined previously, and an in vitro peanut IgE (CAP-FEIA) result of 7 kU/L or greater. - Subjects must be free of any clinically significant disease which may interfere with study evaluations. Exclusion Criteria: - Use of antihistamines or decongestant therapy 7 days prior to the clinic visit. (antihistamines eg. diphenhydramine, desloratadine etc or throughout the desensitization phase of the study. - Patients who had an acute allergic reaction to food other than peanut, drugs, or stinging insects one month prior to the recruitment clinic visit - Patients who have had a respiratory infection one month prior to the recruitment clinic visit. - Patients with significant or uncontrolled asthma, (inhaled corticosteroids (fluticasone >500 mcg per day, ciclesonide >400 mcg per day or budesonide >800 mcg per day or the corresponding combination inhalers, oral prednisone in the preceding 1 month and FEV1 < 80% predicted). Nasal steroids, bronchodilators and leukotriene inhibitors will be permitted. If Prednisone is taken, it must also be stopped 1 month prior to blood being drawn if possible. - Patients who received allergy injections (immunotherapy) to environmental allergens at any time in the past. Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines. - Patients with problems related to compliance or following study instructions. Inability to come to hospital every 2 weeks for dose escalation.

Additional Information

Official title Peanut Allergy Oral Immunotherapy Desensitization
Principal investigator Susan Waserman, ME
Description Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future. To determine the dose and kinetics of peanut desensitization (clinically and immunologically) in peanut allergic individuals who undergo low and high dose OIT. To examine whether the severity of peanut allergy as determined by measurements of PAF and PAF AH (possible markers of reaction severity) correlate with the ability of patients undergoing OIT to achieve desensitization To assess quality of life in peanut allergic subjects before and after OIT
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by McMaster University.