On November 14, 2025, a new clinical trial involving the fenoTRACK device was announced, aimed at enhancing the management of asthma by monitoring changes in fractional exhaled nitric oxide (FeNO). The study, sponsored by Biometry Inc, is currently recruiting participants to evaluate changes in FeNO levels among individuals with uncontrolled and controlled asthma. This development targets healthcare professionals, regulatory teams, and clinical experts keen on advancements in asthma monitoring.
What is the fenoTRACK device?
The fenoTRACK device is a medical device designed to measure fractional exhaled nitric oxide (FeNO) levels, a biomarker linked to airway inflammation. This device offers a non-invasive and precise way to monitor asthma, empowering clinicians to make more informed decisions.
By tracking FeNO levels, the device helps in assessing how well asthma is controlled and whether any adjustments to treatment plans are needed. This capability is especially valuable for managing uncontrolled asthma more effectively.
Clinical trial details
The clinical trial, sponsored by Biometry Inc, aims to recruit individuals with varying levels of asthma control: both controlled and uncontrolled cases. Participants will use the fenoTRACK device to monitor changes in FeNO under clinical supervision.
The study seeks to generate robust, real-world data on the device’s performance and its effectiveness in monitoring asthma. This data is intended to support regulatory filings and further development of the device in line with medical device regulations.
This trial aligns with regulatory and clinical approaches by ensuring the safety, performance, and reliability of the device are closely monitored throughout the process.
What sets this trial apart?
Unlike traditional studies relying on subjective clinical assessments, this trial focuses on objective measurement capabilities. FeNO is a validated biomarker for airway inflammation, making it critical to asthma management. The trial will also bridge regulatory and clinical domains by informing decision-making for safe and effective treatment approaches.
How does this impact asthma management?
One significant advantage of the fenoTRACK device lies in its potential to optimize asthma therapy. By providing real-time monitoring, the device enables personalized treatment adjustments, ensuring therapy aligns with a patient’s specific needs.
For individuals with uncontrolled asthma, this study offers new hope in improving symptom management and reducing exacerbations. For healthcare professionals, it opens up pathways to adopt data-driven, precise tools in their practice.
Looking to the future
If successful, the fenoTRACK device could become integral to standard asthma care protocols. This would align with efforts to digitize and innovate chronic disease management, improving patient outcomes globally.
FAQ
- What does FeNO measure?
FeNO measures the level of nitric oxide in exhaled breath, which is a marker of airway inflammation. - Who is eligible for the study?
Individuals with both controlled and uncontrolled asthma are eligible. Look for detailed eligibility criteria on the ClinicalTrials.gov page linked below. - What is the intended outcome of the study?
The trial aims to evaluate the ability of the fenoTRACK device to monitor FeNO accurately and support asthma management decisions. - Where can I learn more?
Visit the ClinicalTrials.gov entry listed in the announcement section for more details.
Conclusion
Asthma management could see transformative improvements with the use of the fenoTRACK device. This clinical trial represents a significant step in validating the device’s capabilities and supporting its integration into clinical practice. Regulatory and clinical teams monitoring innovative asthma solutions should take a close look at this development.
Disclaimer
This article is for informational purposes only and does not constitute legal or clinical advice. Healthcare professionals should consult regulatory guidelines directly.
Official announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07228026?term=medical+device