TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Food Allergy Clinical Trial

— TRADE  

Official title:

TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521711
• Other study ID #: HAH-21-013
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2024
• Source: Hamilton Health Sciences Corporation
• Contact: Heather Le
• Phone: 905-521-2100
• Email: lehea[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Nut Hypersensitivity
• Tree Nut Allergy

Intervention

Other:
• Food
Commercially available powders or liquids

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	AAAAI Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eliciting dose thresholds to food challenge		1 year
Secondary	Quality of life	Food allergy quality of life questionnaire	1 Year