Oral Immunotherapy (OIT) for Peanut Allergy (PnOIT3)

University of North Carolina (UNC)

Status and phase

Completed

Phase 2

Conditions

Peanut Hypersensitivity

Treatments

Drug: Peanut OIT

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00815035

11-2315

Details and patient eligibility

About

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).

Full 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.

Enrollment

16 patients

Sex

All

Ages

1 to 6 years old

Volunteers

No Healthy Volunteers

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)