Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects

Completed

Conditions studied: Peanut Allergy

In brief

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.

Key facts

Study ID

NCT01489514

Run by

University of North Carolina, Chapel Hill

People needed

22

Starts

2011-12-01

Expected to finish

2015-01-01

Last updated by the study team

2015-05-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Environmental Medicine, Asthma and Lung Biology — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.