Utilising Hull Lung Health Study Data to Investigate the Performance of TidalSense Diagnostic Algorithms to Identify COPD and Pre-COPD Among Participants in the FRONTIER Programme.

Beyond-FRONTIER: Utilising Hull Lung Health Study Data to Investigate the Performance of TidalSense Diagnostic Algorithms to Identify COPD and Pre-COPD Among Participants in the FRONTIER Programme

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06788613

Enrollment

1200

Registered

2025-01-23

Start date

2025-08-31

Completion date

2026-09-30

Last updated

2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Emphysema, Emphysema or COPD

Keywords

COPD, Hull Lung Health, TidalSense, N-tidal

Brief summary

Aim: To investigate the potential for N-Tidal to improve COPD diagnosis and enable detection of pre-COPD\*. Objectives: 1. To assess the performance of TidalSense COPD Diagnostic Algorithms for COPD diagnosis in a real-world, head-to-head comparison with post-bronchodilator spirometry among FRONTIER programme participants. 2. To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD. 3. Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year. Aim: Explore the blood biomarker profile among FRONTIER Programme participants to explore a potential role in early COPD identification. Objectives: 1. Investigate the blood biomarker profile (obtained from the Hull Lung Health Study data) of people with i) confirmed COPD, ii) pre-COPD, and iii) no evidence of COPD. 2. Explore a potential role for blood biomarkers in COPD diagnostics. * Pre-COPD is defined, as per the GOLD Report 2023, as individuals who have respiratory symptoms and/or other detectable structural and/or functional abnormalities in the absence of airflow obstruction on forced spirometry. For the purpose of this study, respiratory symptoms will be classified as a CAT score \> 10 during FRONTIER clinic attendance and presence of emphysema on low-dose CT considered evidence of structural lung abnormalities

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to 75 Years

Healthy volunteers

Inclusion criteria

All Hull Lung Health Study participants that attend a one-stop diagnostic clinic appointment as part of the FRONTIER Programme (NHS Lung Health Check) will be eligible for inclusion in this study. Prospective consent provided for use of data for research purposes and for future contact as part of the Hull Lung Health Study Inclusion criteria: * Participants in the Hull Lung Health Check Programme (ever smokers aged 55-75 and registered with a Hull GP) with one or more of the following symptoms during their lung health check: * Breathlessness * Cough * Bronchitis * Recurrent infections * AND/OR evidence of Emphysema on Low Dose CT

Exclusion criteria

-Existing COPD diagnosis noted at the time of their Lung Health Check or new COPD diagnosis since Lung Health Check attendance AND prescribed appropriate COPD therapy.

Design outcomes

Primary

Measure	Time frame	Description
To assess the performance of TidalSense COPD Diagnostic Algorithms for COPD diagnosis in a real-world, head-to-head comparison with post-bronchodilator spirometry among FRONTIER programme (NHS Lung Health Check) participants.	1 year	We will investigate the performance of TidalSense COPD Diagnostic Algorithms (including the sensitivity, specificity, positive predictive value and negative predictive value of TidalSense 'likely' or 'highly likely' outputs) for COPD diagnosis in a real-world, head-to-head comparison with post-bronchodilator spirometry among NHS Lung Health Check participants. It is anticipated that \ 900 patients will participate in the programme.
To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.	1 year	We will investigate the sensitivity, specificity, positive predictive value and negative predictive value of TidalSense 'likely' or 'highly likely' outputs for identifying those that go onto receive a diagnosis of COPD within 1-year of initial review (Pre COPD).
Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year	1 year	We will investigate the sensitivity, specificity, positive predictive value and negative predictive value of TidalSense 'likely' or 'highly likely' outputs for identifying those at risk of developing COPD within 1-year

Secondary

Measure	Time frame	Description
Explore a potential role for blood biomarkers in COPD diagnostics including investigating the blood biomarker profile (obtained from the Hull Lung Health Study data) of people with i) confirmed COPD, ii) pre-COPD, and iii) no evidence of COPD	1 year	blood biomarker profiles (eosinophils, nTProBNP, fibrinogen, CRP, and IL-6) will be reported descriptively for those with confirmed COPD, pre-COPD and no COPD. Initial univariable pre-screening will inform variable inclusion in a multivariable logistic regression model to explore factors associated with COPD and pre-COPD diagnosis. Identified associated factors will be considered for inclusion in Tidalsense's diagnostic algorithms and the impact on performance investigated.

Contacts

Primary ContactMicheal Crooks, Prof

michael.crooks@nhs.net+44 01482 624067

Backup ContactKayleigh Brindle

Kayleigh.brindle@nhs.net; karen.watkins14@nhs.net+44 01482 624067

Outcome results