Status:
COMPLETED
Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Agriculture & Technical State University
Conditions:
Peanut Allergy
Eligibility:
All Genders
18-65 years
Brief Summary
This is a proof of concept study to determine the safety and allergenicity of hypoallergenic peanut product extract as compared to standard peanut extract in an adult population with known peanut alle...
Detailed Description
Peanut allergic volunteers will be identified by positive skin prick test to peanut (peanut extract obtained from Greer laboratories). The peanut extract to be used is FDA approved and is routinely us...
Eligibility Criteria
Inclusion
- Specific allergy to peanut confirmed by positive immediate skin test response.
- Oxygen saturation of \> 94 % at baseline
- Blood pressure within the following parameters (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
- Must be willing and medically able to withhold antihistamine treatment (both H1 and H2) for 3 days prior to starting study medication, and for the duration of the treatment period. Any subject will be told to resume their antihistamine treatment if symptoms require resuming medication.
Exclusion
- Any chronic medical condition including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects. Asthma is not an exclusion criterion.
- Asthmatic patients must be on a stable regimen of asthma therapy which has not changed in the past month prior to entrance into the study.
- Asthmatic or allergic non-asthmatic patients must not be on leukotriene receptor antagonists, as this may potentially interfere with epicutaneous skin testing and in vitro allergen-induced leukotriene production
- Pregnancy or nursing a baby. As this is a phase I study, the potential risk to a fetus cannot be justified.
- Children will not be included in this study as the potential risk to a growing child cannot be justified.
- Adults age 66 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data.
- Known vagal response to venipuncture
- Hypertension, classified as a systolic blood pressure of equal to or greater than 140, and a diastolic blood pressure equal to or greater than 90.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01489514
Start Date
December 1 2011
End Date
January 1 2015
Last Update
May 27 2015
Active Locations (1)
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1
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27516