Cashew Allergy Study in Children: Assessing Desensitization, Efficacy, and Safety (CASCADES Study)
University of North Carolina, Chapel Hill
Summary
The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT. Lab studies and an oral food challenge after 6 months of cashew SLIT will help determine how quickly cashew SLIT begins to take effect.
Description
The CASCADES study is an 18-month randomized, placebo-controlled trial of cashew sublingual immunotherapy (CASHEW SLIT) in children 1-11 years of age with cashew allergy . Children ages 1-11 years with double-blind placebo-controlled food challenge (DBPCFC) proven allergy to cashew randomized 2:1 to active cashew SLIT or placebo. Participants will undergo a 5-month dose buildup period followed by a DBPCFC at month 6. Participants will then complete an additional 12 months of maintenance cashew SLIT or placebo followed by a DBPCFC at month 18. Safety will be assessed throughout the study. Skin…
Eligibility
- Age range
- 1–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 1-11 years at enrollment * Cashew allergy, with allergy defined as: * History of clinical reaction to cashew AND cashew-specific IgE \>/=0.35 kUA/L AND cashew SPT \>/=3 mm * OR if no prior reaction, cashew-specific IgE \>/=5 kUA/L AND cashew SPT \>/=3 mm * Positive Double-Blind Placebo Controlled Food Challenge (DBCPFC) to 443 mg cumulative cashew at enrollment * If female of child-bearing potential, must have a negative urine or serum pregnancy test * If female of childbearing potential (defined as females who have reached menarche or who are 12 years or older), mus…
Interventions
- DrugCashew sublingual immunotherapy
Glycerinated cashew extract for use in sublingual immunotherapy
- DrugPlacebo sublingual immunotherapy
Glycerinated saline for placebo sublingual immunotherapy
Location
- University of North CarolinaChapel Hill, North Carolina