A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children - DBPC Peanut SLIT (SLB)
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.
|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 - DBPC Peanut SLIT|
- 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 ]
- 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 ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: SLB01
Subjects who receive the protein (peanut sublingual drops) at the beginning of the study.
Peanut protein drops which will be placed under the tongue
Other Name: Sublingual Peanut protein
Placebo Comparator: SLB02
Subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.
Glycerol saline drops which will be placed under the tongue
Other Name: Glycerol saline drops
No Intervention: SL Control
Subjects with peanut allergy receiving no SLIT or Placebo; these controls will be enrolled and followed via their allergists as a comparator for the IgE and skin prick tests.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597727
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Wesley Burks, MD||University of North Carolina|