Status:
UNKNOWN
The Effect of Extrinsic Factors on Food Allergy
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Imperial College London
University of Manchester
Conditions:
Peanut Hypersensitivity
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
Food allergy is a common problem, affecting 5-8% of the population. Peanut allergy causes reduced quality of life due to the perceived high risk of severe reactions. Patients rely on accurate labeling...
Detailed Description
N=100 subjects will undergo a baseline challenge to peanut without exacerbating extrinsic factors. These initial baseline challenges will be performed when asthma is well controlled (validated by norm...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- Male and female subject who are 18-45 years of age at the time of study entry (Visit 1) who have a diagnosis of acute peanut allergy as manifested by urticaria, angioedema or respiratory/gastrointestinal tract symptoms, with acute onset of symptoms after ingestion (up to 2h).
- A positive peanut DBPCFC at baseline (Visit 1). This outcome is defined as the onset of objective allergic events after ingestion of peanut protein but not to the placebo. Eligibility to the DBPCFC requires fulfillment of all other eligibility criteria at visit 1.
- Subjects must be able to comply with the study procedures.
Exclusion
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01429896
Start Date
October 1 2012
End Date
October 1 2015
Last Update
January 14 2015
Active Locations (2)
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1
Addenbrooke's Hospital
Cambridge, Cambs, United Kingdom, CB2 2QQ
2
Imperial College
London, London, United Kingdom, W2 1PG