Study of fenoTRACK Device for Monitoring Changes in Exhaled Nitric Oxide in Children and Adults with Uncontrolled and Controlled Asthma

What this Trial Is About

Researchers are studying the fenoTRACK device to monitor fractional exhaled nitric oxide FeNO levels in adults and children with asthma. The study focuses on two groups those with uncontrolled asthma not treated with steroids and those with controlled asthma. The goal is to see if FeNO levels decline after about two weeks of corticosteroid therapy in the uncontrolled group and to evaluate the devices precision and accuracy for both groups during point-of-care and simulated home use. Participants will use the fenoTRACK device to measure FeNO at home and at point-of-care visits. The uncontrolled asthma group undergoes a roughly two-week corticosteroid treatment between Visit 1 and Visit 2, with FeNO measurements taken at both visits to assess changes. The controlled asthma group participates in clinical precision evaluations of the devices measurements during visits and simulated home use without corticosteroid treatment. During the study, participants will perform FeNO measurements at visits and at home, complete asthma control questionnaires, and undergo lung function tests using spirometry. Researchers will track the number of efforts needed to obtain valid FeNO results and compare device readings between home and point-of-care settings. The primary outcome for uncontrolled asthma subjects is the change in FeNO values after treatment, with secondary outcomes including changes in asthma control scores and lung function. The study runs until September 2026, with multiple assessments over about two weeks between visits.

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