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Peanut Allergy Oral Immunotherapy Desensitization

Primary Purpose

Peanut Allergy

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Peanut protein

Oat flour

Antihistamine

About this trial

This is an interventional treatment trial for Peanut Allergy

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Oral Immunotherapy with placebo antihistamines

Double Placebo

Oral Immunotherapy with H1 and H2 antihistamines

Arm Description

500 mg Peanut Protein with placebo antihistamines

Placebo (Oat flour) and placebo 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.

Outcomes

Primary Outcome Measures

Adverse effects

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

Secondary Outcome Measures

Health related quality of life pre and post intervention

Pre and post OIT.

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.

Full Information

NCT ID

NCT01601522

First Posted

July 27, 2011

Last Updated

January 18, 2022

Sponsor

Hamilton Health Sciences Corporation

Collaborators

AllerGen NCE Inc., McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT01601522

Brief Title

Peanut Allergy Oral Immunotherapy Desensitization

Official Title

Peanut Allergy Oral Immunotherapy Desensitization

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

September 2021 (Actual)

Study Completion Date

September 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hamilton Health Sciences Corporation

Collaborators

AllerGen NCE Inc., McMaster University

4. Oversight

Data Monitoring Committee

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Immunotherapy with placebo antihistamines

Arm Type

Experimental

Arm Description

500 mg Peanut Protein with placebo antihistamines

Arm Title

Double Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (Oat flour) and placebo antihistamines

Arm Title

Oral Immunotherapy with H1 and H2 antihistamines

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Peanut protein

Other Intervention Name(s)

Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour

Intervention Description

500 mg

Intervention Type

Procedure

Intervention Name(s)

Oat flour

Intervention Description

500 mg Oat flour

Intervention Type

Drug

Intervention Name(s)

Antihistamine

Other Intervention Name(s)

Desloratadine and Ranitidine

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse effects

Description

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

Time Frame

6-12 months

Secondary Outcome Measure Information:

Title

Health related quality of life pre and post intervention

Description

Pre and post OIT.

Time Frame

6-12 months

Title

Eliciting doses to oral food challenge

Description

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.

Time Frame

6-12 months

Other Pre-specified Outcome Measures:

Title

Immunological changes/Mechanistic outcomes

Description

Various mechanistic outcomes/biomarkers

Time Frame

6-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Waserman, ME

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Susan Waserman, MD

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

McMaster University

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

12. IPD Sharing Statement

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Peanut Allergy Oral Immunotherapy Desensitization

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