Back to resultsTRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation (TRADE)
Primary Purpose
Tree Nut Allergy, Food Allergy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Food
Sponsored by
About this trial
This is an interventional treatment trial for Tree Nut Allergy focused on measuring Immunotherapy, Randomized Controlled Trial (RCT)
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:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Active low dose oral immunotherapy and Placebo sublingual immunotherapy
Placebo low dose oral immunotherapy and Active sublingual immunotherapy
Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy
Arm Description
Outcomes
Primary Outcome Measures
Eliciting dose thresholds to food challenge
Secondary Outcome Measures
Quality of life
Food allergy quality of life questionnaire
Full Information
NCT ID
NCT05521711
First Posted
August 26, 2022
Last Updated
August 26, 2022
Sponsor
Hamilton Health Sciences Corporation
Collaborators
AAAAI Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05521711
Brief Title
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Acronym
TRADE
Official Title
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
AAAAI Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tree Nut Allergy, Food Allergy
Keywords
Immunotherapy, Randomized Controlled Trial (RCT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active low dose oral immunotherapy and Placebo sublingual immunotherapy
Arm Type
Experimental
Arm Title
Placebo low dose oral immunotherapy and Active sublingual immunotherapy
Arm Type
Experimental
Arm Title
Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Food
Intervention Description
Commercially available powders or liquids
Primary Outcome Measure Information:
Title
Eliciting dose thresholds to food challenge
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life
Description
Food allergy quality of life questionnaire
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sue Beaudin, CCRA
Phone
905-525-9140
Ext
22796
Email
beaudins@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Catie Stevens
Phone
905-525-9140
Ext
22796
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Chu, MD PhD FRCPC
Organizational Affiliation
Hamilton Health Sciences & McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Will consider on a case by case basis.
Learn more about this trial
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
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