Clinical trial NCT06788613: 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.
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Emphysema or COPD
Emphysema
Keywords: COPD
Hull Lung Health
TidalSense
N-tidal
Lead sponsor: Chiesi UK
Sponsor class: INDUSTRY
Collaborators: name: Hull University Teaching Hospitals NHS Trust
name: TidalSense
name: Asthma + Lung UK
First posted: 2025-01-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hull Lung Health Study participants that take part in the FRONTIER Programme will be included in this study.

The FRONTIER Programme is a Collaborative Working Project between the NHS (Hull University Teaching Hospitals NHS Trust) and Chiesi LTD. It aims to enable early COPD diagnosis and timely initiation of evidence-based pharmacological and non-pharmacological interventions to improve outcomes for participants of the Hull Lung Health Check Programme, and the linked Hull Lung Health Study, that missed out on spirometry during their initial Lung Health Check due to infection control precautions

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


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
measure: To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.
timeFrame: 1 year
measure: Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Hull York Medical School
name: Micheal Crooks, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hull University Teaching Hospitals NHS Trust
name: Karen Watkins
role: STUDY_CHAIR
References: