Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects (NCT01489514) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects
United States22 participantsStarted 2011-12
Plain-language 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 allergy. This will be assessed by epicutaneous skin prick testing. The hypothesis is that subjects with previously diagnosed peanut allergy will have less epicutaneous reactions to the hypoallergenic peanut product extract.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Size of wheal with epicutaneous testing using non-hypoallergenic extracts.
✕. 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.