# A novel, hand-held, exhaled breath condensate sampler for the clinical research market; applications for asthma, pulmonary injury and inflammation.

> **NIH NIH R41** · SENSIT VENTURES, INC. · 2021 · $255,492

## Abstract

ABSTRACT
 Exhaled breath is one of the most non-invasive human effluents that can be captured and analyzed, and
yet it has minimal presence as a common clinical endpoint measurement in any branch of modern medicine.
There has been a persistent technology gap for both breath sampling and breath analysis, despite the many
vulnerable patient populations and age groups that could be aided by its use. Exhaled gasses include the major
respiratory gasses from the alveolar interface with the blood and hundreds of small volatile organic compounds
(VOCs). Additionally, exhaled breath condensate (EBC) includes respiratory aerosols, extracellular vesicles and
non-volatile compounds that originate from the liquid lining deep inside the lungs. Our group and others have
shown EBC contains thousands of human metabolites and has tremendous diagnostic and therapy-monitoring
potential. A portable breath sampler could also monitor drug regimen therapy compliance, which would
substantially aid clinical trials where participants sometimes fail to appropriately take their treatments. This can
contribute to an increase in statistical “noise” and overall cost and duration of a clinical trial. We have selected
asthma for further demonstrations of clinical research utility because of the broad need to better understand the
plurality of phenotypes of individual patients arising from the complex interplay of environmental triggers,
genotypes, epigenetic/somatic expression and pharmaceutical response. This project will further the
commercialization of a palm-sized hand-held EBC sampler that can be used by patients in their own homes to
sample their breath for analysis.
 Our technology rests on a patented micro-condenser microfabricated “chip” (µCON) that efficiently
samples the breath. The device has a disposable mouthpiece and can be cleaned and reused by the patient.
Upon exhaling into the device for a short period of time, we obtain enough EBC for mass spectrometry analysis
for clinically relevant information. We have previously demonstrated detection of over ~3,000+ untargeted
metabolites, 30 inflammatory biomarkers as well as drugs and drug metabolites in EBC. Our first objective for
this proposed work is to conduct proof-of-concept EBC testing to detect compliance in taking intervention drugs
for asthma. We will select drugs categorized by different uses and mechanisms of action (e.g., β2-Agonist,
inhaled corticosteroid, anticholinergic/antimuscarinic therapy, antileukotriene therapy). Healthy human EBC
spiked with drug standards will be tested for method development and to demonstrate detectability in a native
background. Secondly, we aim to improve the durability and extended use of our breath sampler by exploring
alternative manufacturing methods. For this, we will develop innovative design strategies to consider machine
choices to scale up for rapid manufacturing, interchangeable parts for a streamlined manufacturing pipeline, and
innovations for device assembly and...

## Key facts

- **NIH application ID:** 10323623
- **Project number:** 1R41ES033573-01
- **Recipient organization:** SENSIT VENTURES, INC.
- **Principal Investigator:** CRISTINA ELIZABETH DAVIS
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $255,492
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323623

## Citation

> US National Institutes of Health, RePORTER application 10323623, A novel, hand-held, exhaled breath condensate sampler for the clinical research market; applications for asthma, pulmonary injury and inflammation. (1R41ES033573-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10323623. Licensed CC0.

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