Predicting Peanut Anaphylaxis and Reducing Epinephrine

Study Overview
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Brief Summary
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This research study is testing a new way to look for the early stages of anaphylaxis. Eligible participants will have a small monitor (transepidermal water loss) placed on the forearm during a food challenge (for peanut allergies). This monitor continuously records the amount of water lost through the skin. In a previous study the team learned what values are associated with an anaphylactic reaction. These values are called stopping rules. This study is looking at whether it can use these new stopping rules to end the oral food challenge before a person may show any symptoms.

Official Title
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Transepidermal Water Loss as a Predictor for Severe Allergic Reactions in Oral Food Challenges

Conditions
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Anaphylaxis Food

Intervention / Treatment
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* Device: Transepidermal water loss (TEWL) monitor and stopping rules
* Device: Monitor (TEWL) without stopping rules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a known history of food anaphylaxis to peanut confirmed by an allergist Have had skin and blood food allergy testing to peanut within the past 12 months. Meet the 80% likelihood positive predictive value threshold for peanut allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests per current literature corrected for age. Meet all clinical oral food challenge (OFC) requirements. This includes no asthma or atopic dermatitis exacerbations, no recent viral infections, no recent antibiotics, and no food allergy reactions in the past month. Exclusion Criteria: Any known cardiovascular disease, cancer, pulmonary disease except well-controlled asthma, or other condition that would preclude an OFC otherwise. Any medication use that would interfere with an OFC result. Medications in this category include antihistamines (first or second generation) within 1 week, omalizumab within 3 months, and others listed in the protocol appendix. Any skin condition aside from well-controlled eczema that might impact TEWL measurement, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitor (TEWL) and stopping rules<br>Wears the monitor, and the food challenge will be done using the new stopping rules to end the test. | Device: Transepidermal water loss (TEWL) monitor and stopping rules<br>* The oral food challenge will be done as usual, and participants will wear the TEWL monitor. The research food allergy nurse and doctor will also be looking for signs and symptoms of an allergic reaction. The research study coordinator will be watching the TEWL numbers. If they numbers match the stopping rules, they will tell the doctor and the oral food challenge will be over.<br>|
| Active Comparator: Monitor (TWLG) without stopping rules<br>Wears the monitor, but the stopping rules will not be used to end the food challenge. The food challenge will be done following standard oral food challenge procedures. | Device: Monitor (TEWL) without stopping rules<br>* The oral food challenge will be done as usual, and participants will wear the TEWL monitor. The research food allergy nurse and doctor will be looking for signs and symptoms of an allergic reaction. The research study coordinator will be watching the TEWL numbers, but the stopping rules will not be used to end the oral food challenge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaphylaxis occurrence rates in each group | Any Brighton Level 1, 2, or 3 anaphylaxis. | Approximately 4-6 hours (Day 1 during the food challenge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction rates in each group | Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc) not rising to the definition of anaphylaxis. | Approximately 4-6 hours (Day 1 during the food challenge) | 
| Anaphylaxis severity in each group | This will be graded on a scale of 1 to 5 (where 1 = mild, 5 = death)) according to criteria set forth in the Consortium for Food Allergy Research (CoFAR) Grading Scale. | Approximately 4-6 hours (Day 1 during the food challenge) | 
| Anaphylaxis likelihood in each group based on the Brighton score | The Brighton score gives a 0-3 score of anaphylaxis likelihood (0 = no anaphylaxis, 3 = highly likely). | Approximately 4-6 hours (Day 1 during the food challenge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic reaction to food, Water loss across the skin, Food challenge