Peanut Allergy Oral Immunotherapy Desensitization

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.

Objectives

1. To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure.
2. To assess quality of life in peanut allergic subjects before and after desensitization.
3. To compare serum metabolites in peanut allergic and non peanut allergic subjects.

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Procedure: Peanut protein; Procedure: Oat flour; Drug: Antihistamine

Detailed 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.

Objectives:

1. To determine whether premedication with desloratidine and ranitidine results in fewer side effects during desensitization procedure.
2. To assess quality of life in peanut allergic subjects before and after desensitization.
3. To compare serum metabolites in peanut allergic and non peanut allergic subjects.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Immunotherapy with placebo antihistamines; 500 mg Peanut Protein with placebo antihistamines	Procedure: Peanut protein; 500 mg; Other Names: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour
Placebo Comparator: Double Placebo; Placebo (Oat flour) and placebo antihistamines	Procedure: Oat flour; 500 mg Oat flour
Active Comparator: Oral Immunotherapy with H1 and H2 antihistamines; 500 mg Peanut Protein with Dosage of desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) and ranitidine be 5ml (15mg/ml=75 mg) po bid.	Procedure: Peanut protein; 500 mg; Other Names: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour; Drug: Antihistamine; Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid; Other Names: Desloratadine and Ranitidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Frequency and risk of adverse events, overall and stratified by organ system and severity	6-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life pre and post intervention	Pre and post OIT.	6-12 months
Eliciting doses to oral food challenge	Patients will be challenged at the end of the treatment period with peanut at the end to determine the change from threshold that they are able to tolerate.	6-12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunological changes/Mechanistic outcomes	Various mechanistic outcomes/biomarkers	6-12 months

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: McMaster University; AllerGen NCE Inc.
• Investigators: Principal Investigator: Susan Waserman, MD, McMaster University; Principal Investigator: Susan Waserman, ME, McMaster University

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H2 Antagonists; Ranitidine; Desloratadine; Histamine H1 Antagonists; Histamine Antagonists
• Other Study ID Numbers: REB 07-348