TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorHamilton Health Sciences Corporation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Food
Other interventionCommercially available powders or liquids
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Active low dose oral immunotherapy and Placebo sublingual immunotherapyExperimental treatment 1 intervention
Group B: Placebo low dose oral immunotherapy and Active sublingual immunotherapyExperimental treatment 1 intervention
Group C: Placebo low dose oral immunotherapy and Placebo sublingual immunotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Eliciting dose thresholds to food challenge
Time frame
1 yearSecondary outcomes
1
Quality of life
Food allergy quality of life questionnaire
Time frame
1 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hamilton Health Sciences Corporation
Lead sponsor
AAAAI Foundation
Collaborator
Source ClinicalTrials.gov