Text Size

Double Blind Peanut Sublingual Immunotherapy (PN SLIT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wesley Burks, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00597727
First received: January 7, 2008
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  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
 Drug: Sublingual Peanut protein
Drug: Glycerol saline drops
Other: SL

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children

Resource links provided by NLM:

Drug Information available for: Glycerin
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

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 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SLB01
Subjects who receive the protein at the beginning of the study.
 Drug: Sublingual Peanut protein
Peanut protein drops which will be placed under the tongue
Placebo Comparator: SLB02
Subjects who receive placebo at the beginning of the study.
 Drug: Glycerol saline drops
Glycerol saline drops which will be placed under the tongue
SL
Subjects with peanut allergy receiving no SLIT or Placebo
 Other: SL
Comparison with SLIT and placebo

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
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Wesley Burks, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Wesley Burks, MD, Chairman, Department of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00597727     History of Changes
Other Study ID Numbers: 00001553
Study First Received: January 7, 2008
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Peanut Allergy

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

ClinicalTrials.gov processed this record on October 17, 2012