Tree Nut AllergyTRADENCT05521711
TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
A study testing Food in people with Tree Nut Allergy and Food Allergy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Tree Nut Allergy, Food Allergy
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario
Heather Le
About this study
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
- Being tested
- Food
- Keywords
- Immunotherapy, Randomized Controlled Trial (RCT)
- Medical subject headings
- Nut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
Commercially available powders or liquids
| Study group | Role | What they receive |
|---|---|---|
| Active low dose oral immunotherapy and Placebo sublingual immunotherapy | Experimental | Not described Receives: Other: Food |
| Placebo low dose oral immunotherapy and Active sublingual immunotherapy | Experimental | Not described Receives: Other: Food |
| Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy | Experimental | Not described Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliciting dose thresholds to food challenge
Measured: 1 year
Secondary outcomes (1)
Quality of life
Food allergy quality of life questionnaire
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tree Nut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- AAAAI Foundation
- Responsible party
- Sponsor
- Investigators
- Derek Chu, MD PhD FRCPC, Principal investigator, Hamilton Health Sciences & McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521711
- Sponsor's protocol ID
- HAH-21-013
- Acronym
- TRADE
- Status last verified
- May 2024
- First submitted
- 26 Aug 2022
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will consider on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
- ClinicalTrials.gov ID
- NCT05521711
- Acronym / sponsor ID
- TRADE / HAH-21-013
- Conditions
- Tree Nut Allergy, Food Allergy
- Keywords
- Immunotherapy, Randomized Controlled Trial (RCT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- AAAAI Foundation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active low dose oral immunotherapy and Placebo sublingual immunotherapy | Experimental | Other: Food |
| Placebo low dose oral immunotherapy and Active sublingual immunotherapy | Experimental | Other: Food |
| Placebo low dose oral immunotherapy and Placebo sublingual immunotherapy | Experimental | Other: Food |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoodCommercially available powders or liquids | Other | 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 |
Primary outcome
Eliciting dose thresholds to food challenge
Time frame: 1 year
1 secondary outcome
Quality of life
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No. Will consider on a case by case basis.
Related trials for Tree Nut Allergy
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
Not yet recruitingPhase 2
UNC Cashew Sublingual Immunotherapy
Cashew Nut Allergy, Tree Nut Allergies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derek Chu, MD PhD FRCPC principal investigator
Hamilton Health Sciences & McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food in people with Tree Nut Allergy and Food Allergy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Le (905-521-2100 ext. 75153, lehea@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliciting dose thresholds to food challenge (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.