Food Allergy, Tree Nut Allergy
Conditions
Keywords
Immunotherapy, Randomized Controlled Trial (RCT)
Brief summary
Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.
Interventions
OTHERFood
Commercially available powders or liquids
Sponsors
AAAAI Foundation
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
Exclusion criteria
1. History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation 2. Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years 3. Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months 4. Use of biologics, other food immunotherapy or experimental treatment in past 6 months. 5. Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits 6. Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eliciting dose thresholds to food challenge | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 1 Year | Food allergy quality of life questionnaire |
Countries
Canada
Contacts
Primary ContactHeather Le
Outcome results
None listed