TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

Not Applicable

Recruiting

• Conditions: Tree Nut Allergy; Food Allergy
• Interventions: Other: Food

• Registration Number: NCT05521711
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Study Start: 2023-09-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2026-11-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active low dose oral immunotherapy and Placebo sublingual immunotherapy	Food	-
Placebo low dose oral immunotherapy and Active sublingual immunotherapy	Food	-
Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy	Food	-

Primary Outcome Measures

Name	Time	Method
Eliciting dose thresholds to food challenge	1 year

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 Year	Food allergy quality of life questionnaire

Trial Locations

Locations (1)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada