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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06437171
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AAADRS Clinical Research Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Additional Details

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. Twenty (20) participants will be enrolled over a 9-month enrollment period from an allergy and asthma medical specialty clinic. Should the participant meet all eligibility criteria, then following the Screening Period, the participant will be dosed with OMA and asked to continue to follow their food avoidance regimen. Participants will return to the clinic every two weeks for 16-weeks, and then every 2 or 4-weeks (depending on dosing) for the remaining 36-weeks, for a total of 52-weeks. Primary endpoint analyses will occur at Week 16 and Week 52. Description of XOLAIR treatment schedule: Omalizumab will be dosed according to the OUtMATCH Study dosing. Patients will be monitored for acute hypersensitivity reactions for at least 61 minutes after the end of the injection. Epinephrine and parenteral diphenhydramine must be readily available for immediate use if required to treat a hypersensitivity reaction; site personnel must be able to detect and treat such reactions. Patients with severe hypersensitivity reactions (e.g., stridor, angioedema, life-threatening change in vital signs) must be withdrawn from study treatment. All adverse events of systemic hypersensitivity reactions or anaphylactoid or anaphylaxis reactions must be reported within 24 hours to the Sponsor.

Arms & Interventions

Arms

Other: Open Label Injection of Omalizumab

Omalizumab dose and frequency based on baseline patient weight and total IgE

Interventions

Biological: - Omalizumab

Omalizumab dose and frequency based on baseline subject weight and total IgE

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

AAADRS Clinical Research Center, Coral Gables, Florida

Status

Recruiting

Address

AAADRS Clinical Research Center

Coral Gables, Florida, 33134

Site Contact

Miguel J Lanz, MD

[email protected]

305-444-0441

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