Using FeNO to Monitor Allergic Reactions in Patients with Multiple Food Allergies

The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies

This study is testing if a medication called Omalizumab can help people with multiple food allergies by looking at changes in a breath test marker over a year.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 6 Years and up
• Sex: All
• Sponsor: AAADRS Clinical Research Center (Academic / other)
• Drugs / interventions: Omalizumab
• Locations: 1 site (Coral Gables, Florida)
• Trial ID: NCT06437171 on ClinicalTrials.gov

What this trial studies

This Phase IV, open-label, single-center study aims to evaluate the change in fractional exhaled nitric oxide (FeNO) as a marker of clinical response to Omalizumab (OMA) in participants with multiple food allergies. A total of 20 participants will be enrolled from an allergy and asthma specialty clinic, and they will receive OMA while continuing their food avoidance regimen. Participants will return to the clinic every two weeks for 16 weeks, followed by less frequent visits for a total of 52 weeks, with primary endpoint analyses occurring at Weeks 16 and 52. The study will monitor for any adverse reactions, particularly hypersensitivity, during treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 6 years and older with a documented history of food allergies to specific foods such as peanuts, milk, eggs, and tree nuts.

Not a fit: Patients with asthma requiring maintenance medication or other significant respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new biomarker for monitoring allergic reactions and improving treatment strategies for patients with multiple food allergies.

How similar studies have performed: While the use of FeNO as a biomarker is established in asthma management, its application in food allergies is less common, making this approach relatively novel.

Eligibility criteria

Inclusion 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)

Exclusion Criteria:

* 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 this trial is running

Coral Gables, Florida

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

Study contacts

• Study coordinator: Miguel Lanz, MD

Conditions Food Allergy; Multiple Food Allergies; Biomarker