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Double Blind Peanut Sublingual Immunotherapy (PN SLIT)
This study is ongoing, but not recruiting participants.
First Received: January 7, 2008   Last Updated: June 10, 2009   History of Changes
Sponsor: Duke University
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00597727
  Purpose

The specific aim of this study is to desensitize peanut-allergic subjects with peanut allergen-specific, sublingual immunotherapy (SLIT) by placing drops of peanut protein under the tongue which will be absorbed. The hypothesis is that peanut SLIT will desensitize patients with peanut allergic reactions by changing the subject's immune system to adapt to peanuts.


Condition Intervention
Food Hypersensitivity
Other: Peanut protein
Other: Glycerol saline drops
Other: Blood draw and skin tests

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title: A Double-Blinded, Placebo-Controlled Study of Peanut Sublingual Immunotherapy in Children

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Subject will successfully pass a double blind placebo controlled food challenge at the end of the study after having been off the sublingual immunotherapy for 2 to 4 weeks. [ Time Frame: End of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The peanut specific IgE will have decreased from the level at the start of the study. [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SLB01: Active Comparator
Subjects who receive the protein at the beginning of the study.
Other: Peanut protein
Peanut protein drops which will be placed under the tongue
SLB02: Placebo Comparator
Subjects who receive placebo at the beginning of the study.
Other: Glycerol saline drops
Glycerol saline drops which will be placed under the tongue
SL
Control subjects
Other: Blood draw and skin tests
Blood draws to compare the immunological system of peanut allergic children to age matched children who are actively participating in the study. Titrated skin prick tests to peanut will also be compared between the 3 groups.

Detailed Description:

In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis is the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions.

The goal of this study is to develop peanut sublingual immunotherapy (IT) for patients with peanut allergic reactions. This study is designed to utilize the extensive knowledge of the allergens involved in peanut hypersensitivity to devise an immunotherapeutic approach that would lower the risk of anaphylactic reactions (systemic IgE-mediated allergic reaction) and would down regulate peanut-specific T cells in peanut-allergic patients.

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND
  • History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

Exclusion Criteria:

  • History of severe life-threatening anaphylaxis to peanut,
  • Medical history that would prevent a DBPCFC to peanut,
  • Unable to cooperate with challenge procedures, or
  • Unable to be reached by telephone for follow-up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597727

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Wesley Burks, MD Duke University
Principal Investigator: Wesley Burks, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University Medical Center ( A. Wesley Burks, MD )
Study ID Numbers: 00001553
Study First Received: January 7, 2008
Last Updated: June 10, 2009
ClinicalTrials.gov Identifier: NCT00597727     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Peanut Allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Glycerol
Immune System Diseases
Physiological Effects of Drugs
Hypersensitivity, Immediate
Protective Agents
Cryoprotective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009