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.

Chiesi

Status: Not yet enrolling

Conditions: Emphysema; COPD; Emphysema or COPD

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06788613

Beyond-FRONTIER

Details and patient eligibility

About

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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,200 participants in 2 patient groups

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

Description:

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.

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

Description:

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.