TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation (TRADE)

May 30, 2024 updated by: Hamilton Health Sciences Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Heather Le
  • Phone Number: 75153 905-521-2100
  • Email: lehea@hhsc.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • McMaster University Medical Centre
        • Contact:
          • Heather Le

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active low dose oral immunotherapy and Placebo sublingual immunotherapy
Other: Food
Commercially available powders or liquids
Experimental: Placebo low dose oral immunotherapy and Active sublingual immunotherapy
Other: Food
Commercially available powders or liquids
Experimental: Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy
Other: Food
Commercially available powders or liquids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eliciting dose thresholds to food challenge
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 1 Year
Food allergy quality of life questionnaire
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

AAAAI Foundation

Investigators

  • Principal Investigator: Derek Chu, MD PhD FRCPC, Hamilton Health Sciences & McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAH-21-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will consider on a case by case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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