Oral Immunotherapy (OIT) for Peanut Allergy - Full Text View

Sponsor:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00815035

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	Other: Peanut flour Other: 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:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by Duke University:

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:	June 2009
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2012 (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.	Other: Peanut flour Peanut flour will be given in increasing amounts.
Placebo Comparator: Oat flour These subjects will be randomized to receive oat flour.	Other: 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 DCRU. 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 SpO2 < 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 NHLBI guidelines
Inability to discontinue antihistamines for skin testing and OFCs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815035

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:

Wesley Burks, MD

Duke University

More Information

Publications:

Patriarca G, Nucera E, Roncallo C, Pollastrini E, Bartolozzi F, De Pasquale T, Buonomo A, Gasbarrini G, Di Campli C, Schiavino D. Oral desensitizing treatment in food allergy: clinical and immunological results. Aliment Pharmacol Ther. 2003 Feb;17(3):459-65. Erratum in: Aliment Pharmacol Ther. 2003 May 1;17(9):1205.

Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. Epub 2006 Oct 27.

Responsible Party:	A. Wesley Burks, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00815035 History of Changes
Other Study ID Numbers:	00008152, 5R01-AI068074-02
Study First Received:	December 26, 2008
Last Updated:	June 12, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Duke University:

Peanut Allergy

Additional relevant MeSH terms:

Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 23, 2012