Trial record 2 of 18 for:    Open Studies | "Peanut Hypersensitivity"

Peanut Allergy Oral Immunotherapy Desensitization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
AllerGen NCE Inc.
McMaster University
Information provided by (Responsible Party):
Dr. Susan Waserman, McMaster University
ClinicalTrials.gov Identifier:
NCT01601522
First received: July 27, 2011
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Peanut Allergy
Procedure: Peanut protein
Procedure: Oat flour
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peanut Allergy Oral Immunotherapy Desensitization

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Ability to tolerate peanut [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Lessening of side effects compared to placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Immunological changes driving the desensitization/tolerance process [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


  • Quality of life pre and post OIT will be done. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pre and post OIT.


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601522

Contacts
Contact: Susan Waserman, MD 905-521-5030 waserman@mcmaster.ca
Contact: Andrea Marrin, MD 905-521-2100 ext 76374 andreamarrin@gmail.com

Locations
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Susan Waserman, MD    905 521-2100 ext 76374    waserman@mcmaster.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
AllerGen NCE Inc.
McMaster University
Investigators
Principal Investigator: Susan Waserman, ME McMaster University
Principal Investigator: Susan Waserman, MD McMaster University
  More Information

No publications provided

Responsible Party: Dr. Susan Waserman, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01601522     History of Changes
Other Study ID Numbers: REB 07-348
Study First Received: July 27, 2011
Last Updated: May 16, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014