Clinical Trial

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

Recruiting
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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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-11-11; most recent amendment 2026-05-29.
Trial Details
NCT Number NCT07228026
Lead Sponsor Biometry Inc
Conditions Asthma
Enrollment 160 participants
Start Date 2025-09-17
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-02