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.
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 prick testing (SPT), blood sampling, and saliva collection will be performed at baseline and at months 1, 3, 6, 12, and 18 to evaluate for immune biomarker changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Glycerinated cashew extract for use in sublingual immunotherapy
Glycerinated saline for placebo sublingual immunotherapy
University of North Carolina
Chapel Hill, North Carolina, United States
Desensitization to cashew at month 18
Percentage of participants tolerating \>/= 1043 mg during cashew DBPCFC at month 18
Time frame: 18 months
Full desensitization to cashew at month 18
Percentage of participants passing the 4043 mg cashew DBPCFC at month 18
Time frame: 18 months
Desensitization to cashew at month 6
Percentage of participants passing the 1043 mg cashew DBPCFC at month 6
Time frame: 6 months
Adverse events related to study drug dosing
Percentage of participants reporting adverse events within 2 hours of study drug administration determined by the PI to be possibly or probably associated with study drug dosing.
Time frame: 18 months
Change in cashew skin prick testing
Change in SPT wheal to cashew extract
Time frame: Baseline, Months 6 and 18
Change in cashew Immunoglobulin E (IgE)
Change in cashew-specific IgE (blood samples)
Time frame: Baseline, Months 6 and 18
Change in cashew Immunoglobulin G4 (IgG4)
Change in cashew-specific IgG4 (blood samples)
Time frame: Baseline, Months 6 and 18
Change in Cashew-Specific IgG4/IgE Ratio
Change in cashew-specific IgG4/IgE ratio (blood samples)
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Time frame: Baseline, Months 6 and 18