Peanut Allergy Oral Immunotherapy Desensitization

NCT ID: NCT01601522

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2021-09-30

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.

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.

Conditions

Peanut Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Immunotherapy with placebo antihistamines

500 mg Peanut Protein with placebo antihistamines

Group Type: EXPERIMENTAL

Peanut protein

Intervention Type: PROCEDURE

500 mg

Double Placebo

Placebo (Oat flour) and placebo antihistamines

Group Type: PLACEBO_COMPARATOR

Oat flour

Intervention Type: PROCEDURE

500 mg Oat flour

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.

Group Type: ACTIVE_COMPARATOR

Peanut protein

Intervention Type: PROCEDURE

500 mg

Antihistamine

Intervention Type: DRUG

Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid

Interventions

Peanut protein

500 mg

Intervention Type: PROCEDURE

Oat flour

500 mg Oat flour

Intervention Type: PROCEDURE

Antihistamine

Desloratidine 5 ml po od (0.5mg/ml = 2.5 mg) Ranitidine 5ml (15mg/ml=75 mg) po bid

Intervention Type: DRUG

Other Intervention Names

Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour; Desloratadine and Ranitidine

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AllerGen NCE Inc.

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Dr. Susan Waserman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Waserman, ME

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Susan Waserman, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

REB 07-348

Identifier Type: -

Identifier Source: org_study_id