- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05521711
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation (TRADE)
August 26, 2022 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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
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: Sue Beaudin, CCRA
- Phone Number: 22796 905-525-9140
- Email: beaudins@mcmaster.ca
Study Contact Backup
- Name: Catie Stevens
- Phone Number: 22796 905-525-9140
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
Genders Eligible for Study
All
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:
- History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation
- Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
- Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months
- Use of biologics, other food immunotherapy or experimental treatment in past 6 months.
- Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
- 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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Active low dose oral immunotherapy and Placebo sublingual immunotherapy
|
Commercially available powders or liquids
|
EXPERIMENTAL: Placebo low dose oral immunotherapy and Active sublingual immunotherapy
|
Commercially available powders or liquids
|
EXPERIMENTAL: Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy
|
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.
Collaborators
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 (ANTICIPATED)
November 1, 2022
Primary Completion (ANTICIPATED)
November 1, 2026
Study Completion (ANTICIPATED)
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)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
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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