UNC Cashew Sublingual Immunotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-11
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
Qualifiers
Age 1-11 years at enrollment
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
Disqualifiers
Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol
History of severe anaphylaxis to cashew defined as neurological compromise or requiring intubation/mechanical ventilation
Known oat, wheat, or glycerin allergy
Global Initiative for Asthma (GINA) 2024 criteria for uncontrolled asthma
Trial design
Treatments tested in this trial
- Cashew sublingual immunotherapy
- Placebo sublingual immunotherapy
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Food Allergy Research & Education
Collaborator
Source ClinicalTrials.gov