Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects
NCT07228026 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 160
Last updated 2026-03-24
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
Conditions
Interventions
- DEVICE
-
fenoTRACK 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.
Sponsors & Collaborators
-
Biometry Inc
lead INDUSTRY
Principal Investigators
-
Philip E. Silkoff, MD · Precision ClinOps LLC
Eligibility
- Min Age
- 5 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-17
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- United States
Study Locations
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