FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA

Running, not enrolling · Phase 4

Conditions studied: Food Allergy

In brief

This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.

Key facts

Study ID

NCT06437171

Run by

AAADRS Clinical Research Center

People needed

20

Starts

2024-06-03

Expected to finish

2026-12-01

Last updated by the study team

2025-08-14

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet the following criteria for study entry:
• Able and willing to provide written informed consent from patient and parent or guardian and to comply with the study protocol.
• Age 6 years of age or older at Visit 1
• Documented history of food allergy to one or more of the following foods based on SPT performed at baseline visit:
• peanut
• milk
• egg
• tree nuts (Walnut/Pecan, Cashew/Pistachio, Almond, Hazelnut, Brazil nut)

You may not qualify if…

• Patients who meet any of the following criteria will be excluded from study entry:
• Diagnosis of asthma requiring maintenance medication, including inhaled steroids, leukotriene modifiers, LABA/ICS, biologics medications (Intermittent asthma [Step 1] is allowed and defined according to the 2020 NAEPP guidelines (as 'asthma requiring only prn SABA use) and FEV1 < 80% of predicted normal.
• Diagnosis of nasal polyps, cystic fibrosis or any respiratory condition that will skew normally occurring FeNO levels
• FeNO (measured in ppb) is lower than a value expected for the age, height, and gender of the participant or inability to perform respiratory collection maneuver
• Systemic steroids, leukotriene modifiers, or nasal steroids for any cause/diagnosis within 4 weeks of baseline
• Biologic use, for any diagnosis, within five half-lives of Screening
• Antibiotic use, systemic/oral/intramuscular, for any cause/diagnosis within 2 weeks of baseline
• Active smoker, cigarette, cigar, vape, recreational, and/or prior 10 pack year history
• Participant weight or IgE levels outside of the dosing table for OMA
• Known history of anaphylaxis/hypersensitivity to OMA
• Any medical condition that is serious or unstable that in the opinion of the PI could confound the study results and/or interfere with subject participation or adherence
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of OMA
• Women of childbearing potential must have a negative serum pregnancy test result during the screening period

Where it is running

• AAADRS Clinical Research Center — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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