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.

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Chiesi UK · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• COPD
• Emphysema or COPD
• Emphysema

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-01-01
• Completion: 2026-09-30
• First posted: 2025-01-23
• Last updated: 2025-05-31