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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-75
SponsorChiesi UK

About this trial

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

Qualifiers

Breathlessness

Cough

Bronchitis

Recurrent infections

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,200 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators

Chiesi UK

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Collaborator

TidalSense

Collaborator

Asthma + Lung UK

Collaborator