TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
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.
| Condition(s) | Tree Nut Allergy, Food Allergy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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; a |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Hamilton Health Sciences Corporation |
| Locations | Hamilton, Ontario, Canada |
| Start date | 2023-09-01 |
| NCT ID | NCT05521711 |
| Official listing | https://clinicaltrials.gov/study/NCT05521711 |