Peanut Allergy Oral Immunotherapy Desensitization

• ClinicalTrials.gov Identifier: NCT01601522
• Recruitment Status: Completed
• First Posted: May 18, 2012
• Last Update Posted: February 2, 2022
• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: AllerGen NCE Inc.; McMaster University
• Information provided by (Responsible Party): Dr. Susan Waserman, McMaster University

Study Description

Brief 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.

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.

Condition or disease	Intervention/treatment	Phase
Peanut Allergy	Procedure: Peanut protein; Procedure: Oat flour; Drug: Antihistamine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Peanut Allergy Oral Immunotherapy Desensitization
• Study Start Date: February 2012
• Actual Primary Completion Date: September 2021
• Actual Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oral Immunotherapy with placebo antihistamines; 500 mg Peanut Protein with placebo antihistamines	Procedure: Peanut protein; 500 mg; Other Name: 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 Name: 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 Name: Desloratadine and Ranitidine

Outcome Measures

Primary Outcome Measures :

1. Adverse effects [ Time Frame: 6-12 months ]
   Frequency and risk of adverse events, overall and stratified by organ system and severity

Secondary Outcome Measures :

1. Health related quality of life pre and post intervention [ Time Frame: 6-12 months ]
   Pre and post OIT.
2. Eliciting doses to oral food challenge [ Time Frame: 6-12 months ]
   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.

Other Outcome Measures:

1. Immunological changes/Mechanistic outcomes [ Time Frame: 6-12 months ]
   Various mechanistic outcomes/biomarkers

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Canada, Ontario

McMaster University

Hamilton, Ontario, Canada, L8N 3Z5

Sponsors and Collaborators

Hamilton Health Sciences Corporation

AllerGen NCE Inc.

McMaster University

Investigators

• Principal Investigator: Susan Waserman, ME; McMaster University
• Principal Investigator: Susan Waserman, MD; McMaster University

More Information

• Responsible Party: Dr. Susan Waserman, Professor, McMaster University
• ClinicalTrials.gov Identifier: NCT01601522
• Other Study ID Numbers: REB 07-348
• First Posted: May 18, 2012
• Last Update Posted: February 2, 2022
• Last Verified: January 2022

Additional relevant MeSH terms:

Peanut Hypersensitivity; Nut and Peanut Hypersensitivity; Hypersensitivity; Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Ranitidine; Desloratadine; Histamine Antagonists; Histamine H1 Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Histamine H1 Antagonists, Non-Sedating; Histamine Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Histamine H2 Antagonists