RecruitingNCT07228026

Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects

A Combined Prospective, Multicenter, Non-Randomized, Open-Label, Point-of-Care and Home Use Pivotal Study of the fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Non-Steroid-Treated Adult and Pediatric Uncontrolled Asthma Subjects and a Prospective Multicenter Clinical Precision Evaluation for Point-of-Care and Home Use in Adult and Pediatric Controlled Asthma Subjects


Sponsor

Biometry Inc

Enrollment

160 participants

Start Date

Sep 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study incorporates objectives directed at two subject cohorts: 1. Uncontrolled Adult and Pediatric Asthma Subjects: To demonstrate a statistically significant and clinically meaningful decline in Point Of Care (POC) FeNO as measured by the fenoTRACK device, after an approximately 2-week course of corticosteroid therapy in adults and children with non-steroid treated uncontrolled asthma. 2. Controlled Adult and Pediatric Asthma Subjects: * To evaluate within-session clinical precision during Visit 1 and Visit 2 for the fenoTRACK device for simulated at home FeNO, and at POC * To evaluate within-session clinical precision for home fenoTRACK use


Eligibility

Min Age: 5 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new home device called fenoTRACK, which measures exhaled nitric oxide (a marker of airway inflammation) in people with asthma. Researchers want to see if the device accurately tracks changes in asthma control over time in both well-controlled and poorly controlled asthma. **You may be eligible if...** - You (or your child) are 5 years old or older with a diagnosis of asthma - For the uncontrolled asthma group: you have symptoms on at least 2 days per week (coughing, wheezing, shortness of breath, etc.) and elevated exhaled nitric oxide levels - For the controlled asthma group: you have had asthma for at least 180 days and it is well-managed - You are willing and able to complete all study procedures **You may NOT be eligible if...** - You do not have an asthma diagnosis - You do not meet the symptom or nitric oxide threshold for the uncontrolled group - You are unable or unwilling to complete the study visits and procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEfenoTRACK Device

Home FeNO Monitoring: FeNO measurement will be performed. POC Longitudinal Response to Treatment: FeNO measurement will be performed in the office both the simulated home environment and POC environment.


Locations(13)

Bensch Clinical Research LLC

Stockton, California, United States

AllerVie Clinical Research

Panama City, Florida, United States

AllerVie Clinical Research

Columbus, Georgia, United States

Paul A Shapero MD

Bangor, Maine, United States

AllerVie Clinical Research

Ellicott City, Maryland, United States

AllerVie Clinical Research

Glenn Dale, Maryland, United States

Nebraska Medical Research Institute, Inc.

Bellevue, Nebraska, United States

Allergy Partners Clinical Research

Asheville, North Carolina, United States

Toledo Institute of Clinical Research Inc

Toledo, Ohio, United States

Orion Clinical Research

Austin, Texas, United States

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Allergy, Asthma & Sinus Center, S.C.

Greenfield, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07228026


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