drugset / Trial / NCT00597727
A Study of Sublingual Immunotherapy in Peanut-allergic Children
Phase 2
Completed
60 enrolled
University of North Carolina, Chapel Hill
National Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedCrossoverTriple-blindTreatment
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.
Timeline
- Start
- 2008-01
- Primary completion
- 2016-03
- Completion
- 2016-03
Outcome
Met primary endpoint
paper the treatment group safely ingested 20 times more peanut protein than the placebo group (median, 1,710 vs 85 mg; P = .011). PMID 21281959 ↗
Publications
- Background Chin SJ, Vickery BP, Kulis MD, Kim EH, Varshney P, Steele P, Kamilaris J, Hiegel AM, Carlisle SK, Smith PB, Scurlock AM, Jones SM, Burks AW. Sublingual versus oral immunotherapy for peanut-allergic children: a retrospective comparison. J Allergy Clin Immunol. 2013 Aug;132(2):476-8.e2. doi: 10.1016/j.jaci.2013.02.017. Epub 2013 Mar 25. No abstract available.
- Results Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, Steele P, Kamilaris J, Vickery B, Burks AW. Sublingual immunotherapy for peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 2011 Mar;127(3):640-6.e1. doi: 10.1016/j.jaci.2010.12.1083. Epub 2011 Feb 1.
- Results Kulis M, Saba K, Kim EH, Bird JA, Kamilaris N, Vickery BP, Staats H, Burks AW. Increased peanut-specific IgA levels in saliva correlate with food challenge outcomes after peanut sublingual immunotherapy. J Allergy Clin Immunol. 2012 Apr;129(4):1159-62. doi: 10.1016/j.jaci.2011.11.045. Epub 2012 Jan 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peanut SLIT | Protein / enzyme biologic | — | Other |