Oral Immunotherapy (OIT) for Peanut Allergy
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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 |
- 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 ]
| 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 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 |
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| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| 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: | September 14, 2012 |
| 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 Immune System Diseases Food Hypersensitivity Hypersensitivity, Immediate |
ClinicalTrials.gov processed this record on May 16, 2013