Beyond-FRONTIER
Research type
Research Study
Full title
Beyond-FRONTIER: Utilising Hull Lung Health Study data to investigate the performance of N-Tidal Diagnose Diagnostic algorithms to identify COPD and pre-COPD among participants in the FRONTIER programme.
IRAS ID
335618
Contact name
Michael Crooks
Contact email
Sponsor organisation
Chiesi Ltd
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a prevalent, smoking-related lung disease with significant associated morbidity and mortality. COPD diagnosis relies on clinical assessment and a breathing test called spirometry. Spirometry measures the volume of air that can be exhaled over time when somebody breathes out as fast and as hard as possible. Specially trained staff are needed to perform and interpret spirometry and it requires reproducible, maximum patient effort. Limited access to spirometry contributes to COPD under-diagnosis, a problem exacerbated by the COVID pandemic.
Before the pandemic, there were around 8,000 people in Hull with COPD and it was estimated that around 5,000 people were living with the condition without a diagnosis. There was almost complete discontinuation of spirometry during the COVID pandemic and, while many clinical services have fully recovered since the pandemic, spirometry has not returned to pre-pandemic levels and consequently COPD diagnosis remains a challenge.
TidalSense developed a hand-held device (N-Tidal Capture) to detect exhaled breath CO2, creating a high resolution trace during normal breathing at rest. N-Tidal Capture is licensed for use in monitoring obstructive airways disease and TidalSense have now developed algorithms that aim to identify COPD based on the generated traces. If TidalSense COPD diagnostic algorithms are shown to accurately identify COPD, this has potential to transform COPD diagnostics.
We will compare TidalSense COPD diagnostic algorithms with clinician COPD diagnosis, informed by post-bronchodilator spirometry (Gold-Standard). Data from the Hull Lung Health Study, a longitudinal cohort study in which participants provide consent for their data to be used for future research relating to lung health will be used for this study. Hull Lung Health Study participants that have participated in a COPD diagnostic programme including both spirometry assessment and use of the N-Tidal Capture device will contribute data for this study.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
25/WM/0055
Date of REC Opinion
30 Apr 2025
REC opinion
Further Information Favourable Opinion