Status:
UNKNOWN
Canadian Peanut Thresholds Study
Lead Sponsor:
McMaster University
Collaborating Sponsors:
AllerGen NCE Inc.
Conditions:
Peanut Allergy
Eligibility:
All Genders
7-65 years
Phase:
NA
Brief Summary
An important gap in the management of peanut allergy is that we do not know the threshold dose, below which most peanut allergic individuals will not react. There is likely a spectrum of reactivity to...
Detailed Description
Overview This study protocol will be modeled on a consensus protocol developed with the input of clinical allergists and other allergy stakeholders to standardize threshold challenge studies \[5-8\]....
Eligibility Criteria
Inclusion
- Children and adults between 7-65 years of age.
- Demonstrated history of peanut allergy based on medical history, positive skin prick test, and peanut-specific IgE CAP-FEIA test. Participants will be confirmed to have peanut allergy based on a history of significant clinical symptoms within 60 minutes of the ingestion of peanut, the presence of specific IgE to peanut (a positive skin prick test to peanut, defined as a wheal 3 mm larger than that of the saline control, and a positive in vitro peanut-specific IgE (CAP-FEIA) test value \>0.35 IU/mL.
- Ability to discontinue all prescribed and over the counter allergy-related medications for suitable withdrawal periods before starting the challenge trial. See Appendix I for specifications.
Exclusion
- Previous desensitization treatment to peanut
- Allergies to any component of the oral challenge matrix
- Unstable allergic conditions such as uncontrolled asthma or chronic urticaria
- Any clinically significant disease/chronic medical condition which may interfere with study evaluations
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01812798
Start Date
May 1 2013
End Date
September 1 2021
Last Update
June 4 2020
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8S 4K1