Clinical trial NCT00597675: Oral Immunotherapy for Peanut Allergy (PMIT)
Official title: Oral Immunotherapy for Peanut Allergy (2nd Generation PMIT Collaboration With Arkansas Children's)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Food Hypersensitivity
Keywords: Peanut allergy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2008-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.

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 mucosal 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 1 to 18 with peanut allergy will be randomized to peanut OIT or placebo. 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. Subjects will undergo a double-blind, placebo-controlled food challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects will then complete at least 36 months of peanut OIT therapy after which once skin prick (\<5 mm) and IgE (\<15 kU/L) criteria are met, they will then complete the end of study DBPCFC. Dosing will continue up to a maximum of 60 months after which even if criteria are not met, the subject will undergo the end of study DBPCFC. Outcome variables of interest include response to DBPCFC, 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 criteria: Inclusion Criteria:

* Subject between 1 and 18 years of age
* EITHER history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts greater than 6 months ago AND peanut specific IgE \>15 kU/L
* OR history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts within the past 6 months AND peanut specific IgE \> 7 kU/L
* A family that will be able to be compliant with all study visits
* All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

* Subjects with a history of severe, anaphylaxis to peanut
* Medical history that would prevent a double blind placebo controlled oral food challenge (DBPCFC/OFC) to peanut
* Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
* Diagnosed oat allergy
* Pregnancy or lactation

Primary outcomes:
measure: The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT.
timeFrame: 36-60 months
Secondary outcomes:
measure: The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment.
timeFrame: 12 months
measure: The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing
timeFrame: Baseline to end of open label phase treatment (36-60 months)
measure: The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood
timeFrame: Baseline to end of open label phase treatment (36-60 months)
measure: The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.
timeFrame: Baseline to end of open label phase treatment (36-60 months)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas Medical Center
state: Arkansas
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Arvil W Burks, MD
role: PRINCIPAL_INVESTIGATOR
References: