Peanut Allergy Oral Immunotherapy Desensitization

NCT01601522 | Completed Phase 2

• 1 other identifier: REB 07-348
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• Adverse effects

  Frequency and risk of adverse events, overall and stratified by organ system and severity

  6-12 months

Secondary Outcomes (2)

• Health related quality of life pre and post intervention

  6-12 months

• Eliciting doses to oral food challenge

  6-12 months

Other Outcomes (1)

• Immunological changes/Mechanistic outcomes

  6-12 months

Study Arms (3)

Oral Immunotherapy with placebo antihistamines

EXPERIMENTAL

500 mg Peanut Protein with placebo antihistamines

Procedure: Peanut protein

Double Placebo

PLACEBO COMPARATOR

Placebo (Oat flour) and placebo antihistamines

Procedure: Oat flour

Oral Immunotherapy with H1 and H2 antihistamines

ACTIVE COMPARATOR

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; Drug: Antihistamine

Interventions

Peanut protein PROCEDURE

500 mg

Also known as: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour

Oral Immunotherapy with H1 and H2 antihistamines; Oral Immunotherapy with placebo antihistamines

Oat flour PROCEDURE

500 mg Oat flour

Double Placebo

Antihistamine DRUG

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

Also known as: Desloratadine and Ranitidine

Oral Immunotherapy with H1 and H2 antihistamines

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• AllerGen NCE Inc.: collaborator
• McMaster University: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Histamine Antagonists; desloratadine; Ranitidine

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Susan Waserman, ME

  McMaster University

  PRINCIPAL INVESTIGATOR

• Susan Waserman, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: May 18, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-01

Locations

CA (1)