A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
Recruitment status was Active, not recruiting
The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.
Drug: Peanut powder
Drug: Peanut extract
Drug: Placebo extract
Drug: Placebo powder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy|
- The primary endpoint is to determine if sublingual administration of peanut extract and oral administration of peanut powder can induce a 10-fold increase in tolerance as measured by food challenge. [ Time Frame: 1 1/2 years ] [ Designated as safety issue: Yes ]
- The incidence of all serious adverse events on peanut SLIT and peanut OIT. [ Time Frame: 1 1/2 years ] [ Designated as safety issue: Yes ]
- To assess any changes in clinical and mechanistic endpoints. [ Time Frame: 1 1/2 years ] [ Designated as safety issue: No ]
- Peanut tolerance, as determined by oral food challenge (OFC) after being off daily SLIT and OIT for 4 weeks. [ Time Frame: 1 1/2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
These subjects will receive peanut powder given orally and placebo extract given sublingually.
Drug: Peanut powder
Delivered orallyDrug: Placebo extract
These subjects will receive peanut extract given sublingually and placebo powder given orally.
Drug: Peanut extract
Delivered sublinguallyDrug: Placebo powder
To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of PA, (2) a serum IgE specific to peanut of >0.35 kUa/L and a skin prick test (SPT) wheal >3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic.
Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period.
Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084174
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287-3923|
|Principal Investigator:||Robert Wood, MD||Johns Hopkins University|