TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation

NCT ID: NCT05521711

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2027-01-01

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.

Conditions

Tree Nut Allergy; Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active low dose oral immunotherapy and Placebo sublingual immunotherapy

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Commercially available powders or liquids

Placebo low dose oral immunotherapy and Active sublingual immunotherapy

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Commercially available powders or liquids

Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy

Group Type: EXPERIMENTAL

Food

Intervention Type: OTHER

Commercially available powders or liquids

Interventions

Food

Commercially available powders or liquids

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AAAAI Foundation

UNKNOWN

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek Chu, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences & McMaster University

Locations

McMaster University Medical Centre

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Heather Le

Role: CONTACT

lehea@hhsc.ca

905-521-2100 ext. 75153

Facility Contacts

Heather Le

Role: primary

Other Identifiers

HAH-21-013

Identifier Type: -

Identifier Source: org_study_id