Oral Immunotherapy (OIT) for Peanut Allergy (PnOIT3)
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).
|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- Peanut Oral Immunotherapy (PnOIT3)|
- 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 ]
- 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 ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Peanut
These subjects will be randomized to receive the active peanut protein flour.
Peanut flour will be given in increasing amounts.
Other Name: Peanut OIT
Placebo Comparator: Oat flour
These subjects will be randomized to receive oat flour.
Drug: Oat Flour
The doses of oat flour will be increases every 2 weeks until a maintenance dose is achieved.
Other Name: Placebo
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815035
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Wesley Burks, MD||University of North Carolina|