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Trial record 1 of 3 for:    "peanut allergy" AND Waserman
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Peanut Allergy Oral Immunotherapy Desensitization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01601522
Recruitment Status : Active, not recruiting
First Posted : May 18, 2012
Last Update Posted : June 4, 2020
AllerGen NCE Inc.
McMaster University
Information provided by (Responsible Party):
Dr. Susan Waserman, McMaster University

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.

Condition or disease Intervention/treatment Phase
Peanut Allergy Procedure: Peanut protein Procedure: Oat flour Phase 1

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.

To determine the dose and kinetics of peanut desensitization (clinically and immunologically) in peanut allergic individuals who undergo low and high dose OIT.

To examine whether the severity of peanut allergy as determined by measurements of PAF and PAF AH (possible markers of reaction severity) correlate with the ability of patients undergoing OIT to achieve desensitization To assess quality of life in peanut allergic subjects before and after OIT

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peanut Allergy Oral Immunotherapy Desensitization
Study Start Date : February 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Desentization dose
500 mg Peanut Protein
Procedure: Peanut protein
500 mg
Other Name: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour

Placebo Comparator: Placebo
Oat flour
Procedure: Oat flour
500 mg Oat flour

Primary Outcome Measures :
  1. Ability to tolerate peanut [ Time Frame: 6 months ]
    Patients undergoing peanut OIT will be challenged with peanut at the end with a DBPCFC to determine the change from threshold that they are able to tolerate.

Secondary Outcome Measures :
  1. Lessening of side effects compared to placebo [ Time Frame: 6 months ]
  2. Immunological changes driving the desensitization/tolerance process [ Time Frame: 6 months ]

    To examine patients undergoing OIT for PAF and PAF AH to determine if these measurements of reaction severity affect the patient's ability to achieve OIT to peanut.

    To determine the immunological changes in the blood during the desensitization/tolerance process

  3. Quality of life pre and post OIT will be done. [ Time Frame: 6 months ]
    Pre and post OIT.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01601522

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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
AllerGen NCE Inc.
McMaster University
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Principal Investigator: Susan Waserman, ME McMaster University
Principal Investigator: Susan Waserman, MD McMaster University
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Responsible Party: Dr. Susan Waserman, Professor, McMaster University Identifier: NCT01601522    
Other Study ID Numbers: REB 07-348
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate