An innovative instrument for measuring exhaled compounds was demonstrated in Phase I of this project. The novel breath monitor (Breathmeter TM) consists of a tunable mid-IR diode laser, a long optical resonator, and electronics modules for detecting select molecular species in exhaled breath. This system can solve the challenging problem of finding a cost effective, highly sensitive, real-time, monitoring scheme for identifying and quantifying exhaled biomarkers related to airway inflammation and asthma. In Phase I research the technical feasibility of the concept was proved by measurement of exhaled nitric oxide (eNO) and carbon dioxide (eCO2) in a clinical setting. Using the first prototype system, 368 adult and pediatric patients were tested in pulmonary clinics by respiratory therapists using the device under the supervision of a pulmonologist or an allergy immunology specialist. The data collected indicate a correlation between above-normal levels of eNO and asthma. In addition, early longitudinal data indicate that the instrument will be useful for anti-inflammatory treatment monitoring. Early testing also indicates minority and socio-economic asthmatic population differences consistent with previous studies. The long-term goal of the project is commercialization of the proposed technique for quick and large-scale identification of airway inflammation (a precursor condition for asthma) and monitoring of anti-inflammatory treatments in children and adults. NIH SBIR Phase II R&D efforts will concentrate on additional clinical research to 1) sample levels of exhaled nitric oxide in a large population and 2) conduct clinical research correlating eNO with specific respiratory diseases. Thus, the major objectives for Phase II will be: conducting clinical research necessary for demonstrating adequate clinical utility in order to begin clinical trials for FDA approval. To accomplish this Phase II research, additional Breathmeter prototypes will be constructed and medical technicians and clinicians will be recruited to perform work with these instruments. The Ekips Breathmeter has the opportunity to obtain a significant share of the pulmonary function testing market within two years after receiving FDA approval.
