Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * 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)
- * 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
Ages Eligible for Study
6 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No