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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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COPD Emphysema or COPD Emphysema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Head-to-head comparison with post-bronchodilator spirometry among FRONTIER programme participants

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.

No interventions assigned to this group

Explore the blood biomarker profile among FRONTIER study participants to explore COPD identification

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Prospective consent provided for use of data for research purposes and for future contact as part of the Hull Lung Health Study

* 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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No