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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: March 21, 2014
Last verified: March 2014

January 7, 2008
March 21, 2014
January 2008
December 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00597727 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Double Blind Peanut Sublingual Immunotherapy
A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Food Hypersensitivity
  • Drug: Sublingual Peanut protein
    Peanut protein drops which will be placed under the tongue
  • Drug: Glycerol saline drops
    Glycerol saline drops which will be placed under the tongue
  • Other: SL
    Comparison with SLIT and placebo
  • Active Comparator: SLB01
    Subjects who receive the protein (peanut sublingual drops) at the beginning of the study.
    Intervention: Drug: Sublingual Peanut protein
  • Placebo Comparator: SLB02
    Subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.
    Intervention: Drug: Glycerol saline drops
  • SL
    Subjects with peanut allergy receiving no SLIT or Placebo
    Intervention: Other: SL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
1 Year to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597727
00001553
Yes
Wesley Burks, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Wesley Burks, MD University of North Carolina
University of North Carolina, Chapel Hill
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP