| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Peanut Hypersensitivity |
| Purpose: |
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The purpose of this study is to determine whether the addition of anti-IgE treatment will
make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut
allergy.
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| Study summary: |
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The goal of this proposal is to produce a new treatment that would benefit subjects who have
peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and
changing the peanut-specific immune response in subjects who have peanut allergy
(tolerance). This project is designed to study if peanut oral immunotherapy (OIT) will
desensitize subjects with peanut hypersensitivity by regulating their oral and systemic
immune reactivity and cause long-term tolerance. This study will augment other ongoing
studies by looking at whether anti-IgE therapy can reduce side effects and allow for an
accelerated build up phase. Peanut allergic patients greater than 12 years old will undergo
omalizumab (anti-IgE) treatment for 4 months prior to peanut OIT, and they will continue
omalizumab until one month after maintenance therapy. Each subject will have an initial
desensitization phase over 2 days to a goal of 950 mg of peanut powder followed by a build
up phase over 4 months to goal maintenance dose of 8000 mg peanut powder. They will be
randomized to continue maintenance for 12 or 24 months. They will then have an oral food
challenge immediately after stopping peanut OIT to test for desensitization. Four weeks
later, off OIT, another food challenge will be done to assess tolerance. Outcome variables
of interest include results of the DBPCFCs, pre and post skin tests, CAP-FEIA values and
basophil studies. These results will be compared between the starting point and the patient
at the end of the study using appropriate statistical analysis. |
| Criteria: |
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Inclusion Criteria:
- Age 12 years and above of either sex, any race, any ethnicity at the time of the
initial visit
- The presence of IgE specific to peanuts (a positive skin prick test to peanuts
(diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 5 kUA/L
- A history of significant clinical symptoms (urticaria, angioedema, rhinorrhea, nasal
congestion, pruritis, sneezing, abdominal pain, emesis, diarrhea, wheezing, shortness
of breath, lip/tongue swelling, throat itching, throat swelling, impending sense of
doom) occurring within 60 minutes after ingesting peanuts
- Provide signed informed consent
- Women who are sexually active, must agree to use appropriate contraceptive measures
for the duration of the study and for 9 months afterwards
Exclusion Criteria:
- History of severe anaphylaxis to peanut or omalizumab as defined by hypoxia,
hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage,
hypotension, confusion, collapse, loss of consciousness; or incontinence)
- Currently participating in a study using an investigational new drug
- Participation in any interventional study for the treatment of food allergy in the
past 12 months
- Subjects with a known oat or wheat (because of potential cross contamination with
oat) food allergy will be excluded
- Poor control or persistent activation of atopic dermatitis
- Moderate to severe persistent asthma
- Currently being treated with greater than medium daily doses of inhaled
corticosteroids, as defined by the NHLBI guidelines
- Inability to discontinue antihistamines for skin testing and OFCs
- History of other serious underlying disease (i.e., heart disease, diabetes, etc.)
- Women who are pregnant or nursing |
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| Study is available at: |
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Duke University Medical Center
Durham, NC 27710
United States
Primary Contact:
Jane Hainline, RN
Email: Jane.Hainline@duke.edu
Phone: 919-681-8677
Secondary Contact:
Jane Hainline, RN
Email: jane.hainline@duke.edu
Phone: 919-681-8677 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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