Asthma management by monitoring nitric oxide (no) levels in exhaled breath

The National Heart, Lung, and Blood Institute awarded $591,499 to Giner, Inc. on September 1, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837, SBIR Phase I mechanism R43HL184803) to develop a portable, low-cost fractional exhaled nitric oxide (FeNO) breathalyzer for home-based asthma monitoring in children aged six and older.

The device integrates a compact electrochemical nitric oxide sensor, humidity control module, and Bluetooth-enabled smartphone interface to enable children and caregivers to measure FeNO levels at home and transmit data to clinicians for remote monitoring. Phase I work focuses on building and validating a handheld prototype using the Alphasense NO-B4 sensor, developing the humidity control system, and creating real-time signal processing algorithms. The prototype will be evaluated in a clinical study with pediatric asthma patients at Boston Children's Hospital. The innovation addresses barriers to routine FeNO testing by providing user-centered, maintenance-free operation designed specifically for pediatric use, supporting early detection of airway inflammation and timely therapy adjustments.

Performance of work occurs in Auburndale, Massachusetts, with a period of performance from September 1, 2026, through August 31, 2027. The assistance type is a Project Grant.

Abstract

Asthma affects over 28 million people in the U.S. And is the most common chronic illness in children. Effective management depends on accurate monitoring of airway inflammation. Fractional exhaled nitric oxide (feno) is a validated biomarker of airway inflammation, and regular feno monitoring can improve asthma control, reduce exacerbations, and support personalized treatment. However, current feno monitoring technologies are costly, clinic-based, and often not child-friendly. To address this GAP, this project proposes the development of a low- cost, portable feno breathalyzer designed for home use by children aged 6 and up. The proposed system will integrate a compact electrochemical no sensor, humidity control module, and a bluetooth-enabled interface with a companion smartphone APP. This technology will allow children and their caregivers to measure feno levels easily at home and transmit data to clinicians for remote monitoring. Phase i will focus on building and validating a handheld prototype using the alphasense no-B4 sensor, developing a humidity control system, and creating real-time signal processing algorithms. The prototype will be evaluated in a clinical study with pediatric asthma patients at boston children's hospital. The device aims to provide accurate, maintenance-free operation with a user-centered design. A key innovation is its adaptability for pediatric use, addressing current barriers to routine feno testing. This solution supports early detection of airway inflammation and timely therapy adjustments. IT aligns with the NIH mission by improving asthma management and advancing home-based diagnostics. A successful prototype will lay the groundwork for phase II development, regulatory approval, and future commercialization.