Peanut Allergy Oral Immunotherapy Desensitization

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT01601522

Collaborator

AllerGen NCE Inc. (Industry), McMaster University (Other)

Enrollment

Location

Arms

115

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

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:

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2012

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Sep 1, 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 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

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

Outcome Measures

Primary Outcome Measures

Adverse effects [6-12 months]
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 [6-12 months]
Pre and post OIT.
Eliciting doses to oral food challenge [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

Immunological changes/Mechanistic outcomes [6-12 months]
Various mechanistic outcomes/biomarkers

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.