ACTIVE_NOT_RECRUITING

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

Conditions

Food Allergy Multiple Food Allergies Biomarker

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-03

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06437171

Participation Criteria

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.

Ages Eligible for Study:6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

AAADRS Clinical Research Center

Coral Gables, Florida, 33134

United States

Collaborators and Investigators

Sponsor: AAADRS Clinical Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-06-03

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Food Allergy
Multiple Food Allergies
Biomarker

Additional Relevant MeSH Terms

Food Allergy