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Oral Immunotherapy (OIT) for Peanut Allergy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00815035
First received: December 26, 2008
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).


Condition Intervention Phase
Peanut Hypersensitivity
Drug: Peanut flour
Drug: Subjects will receive oral oat flour.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Oral Immunotherapy for Peanut Allergy

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • To treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes long-term tolerance. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the molecular-level effect that peanut OIT has on the peanut-specific cellular and humoral activity/response in peanut-allergic subjects. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Peanut
These subjects will be randomized to receive the active peanut protein.
Drug: Peanut flour
Peanut flour will be given in increasing amounts.
Placebo Comparator: Oat flour
These subjects will be randomized to receive oat flour.
Drug: Subjects will receive oral oat flour.
The doses of oat flour will be increases every 2 weeks until a maintenance dose is achieved.
No Intervention: Control arm
Subjects will be enrolled who meet the inclusion/exclusion criteria and followed as matched controls. These subjects will not receive any treatment.

Detailed Description:

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
  • The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L
  • A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
  • Provide signed informed consent

Exclusion Criteria:

  • History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
  • Currently participating in a study using an investigational new drug
  • Participation in any interventional study for the treatment of food allergy in the past 12 months
  • Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
  • Poor control or persistent activation of atopic dermatitis
  • Moderate to severe persistent asthma
  • Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
  • Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs)
  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: NCT00815035

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Wesley Burks, MD University of North Carolina
  More Information

Publications:
Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00815035     History of Changes
Other Study ID Numbers: 00008152, 5R01-AI068074-02
Study First Received: December 26, 2008
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Peanut Allergy

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

ClinicalTrials.gov processed this record on November 25, 2014