Peanut Allergy Oral Immunotherapy Desensitization
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Peanut Allergy Oral Immunotherapy Desensitization|
- Ability to tolerate peanut [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Patients undergoing peanut OIT will be challenged with peanut at the end with a DBPCFC to determine the change from threshold that they are able to tolerate.
- Lessening of side effects compared to placebo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Immunological changes driving the desensitization/tolerance process [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To examine patients undergoing OIT for PAF and PAF AH to determine if these measurements of reaction severity affect the patient's ability to achieve OIT to peanut.
To determine the immunological changes in the blood during the desensitization/tolerance process
- Quality of life pre and post OIT will be done. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Pre and post OIT.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Desentization dose
500 mg Peanut Protein
Procedure: Peanut protein
Other Name: Old Birginia Byrd Mill 12% Lightly Roasted Peanut Flour
Placebo Comparator: Placebo
Procedure: Oat flour
500 mg Oat flour
Allergic reactions to peanuts and tree nuts account for the majority of fatal and near fatal food allergic reactions, and the only treatment is complete avoidance of peanut. Despite avoidance, the majority of peanut allergic people will accidently ingest peanut. OIT has been shown to desensitize peanut allergic subjects (Hofmann et al. 2009). This would protect patients who have no other treatment, and may even form the basis for true tolerance to peanut in the future.
To determine the dose and kinetics of peanut desensitization (clinically and immunologically) in peanut allergic individuals who undergo low and high dose OIT.
To examine whether the severity of peanut allergy as determined by measurements of PAF and PAF AH (possible markers of reaction severity) correlate with the ability of patients undergoing OIT to achieve desensitization To assess quality of life in peanut allergic subjects before and after OIT
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601522
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Susan Waserman, ME||McMaster University|
|Principal Investigator:||Susan Waserman, MD||McMaster University|