Phase 2
Completed N=60
A Study of Sublingual Immunotherapy in Peanut-allergic Children
Food Hypersensitivity
Source: ClinicalTrials.gov NCT00597727 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing — 45.5; 0; 11.8; 66.7 percentage of participants
Summary
The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing |
45.5; 0; 11.8; 66.7 | — |
| SECONDARY Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing |
26.1; 28.6; 0 | — |
Eligibility 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, OR
- Medical history that would prevent a DBPCFC to peanut, OR
- Subjects with wheat or oat allergy (which are used in the placebo), OR
- Unable to cooperate with challenge procedures, OR
- Unable to be reached by telephone for follow-up
Data sourced from ClinicalTrials.gov (NCT00597727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.