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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COPD, Emphysema or COPD, Emphysema. Basic parameters: 55 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Primary outcome measures
- 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. [Time frame: 1 year]
- To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD. [Time frame: 1 year]
- Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year [Time frame: 1 year]
Secondary outcome measures (1)
- 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 [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06788613 · Beyond-FRONTIER