MedTrace Logo

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.

NCT06788613 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2025-05-31

No results posted yet for this study

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

Sponsors & Collaborators

  • Hull University Teaching Hospitals NHS Trust

    collaborator OTHER_GOV

  • TidalSense

    collaborator INDUSTRY

  • Asthma + Lung UK

    collaborator UNKNOWN

  • Chiesi UK

    lead INDUSTRY

Principal Investigators

  • Micheal Crooks, Prof · Hull York Medical School

  • Karen Watkins · Hull University Teaching Hospitals NHS Trust

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-01-31
Completion
2026-09-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788613 on ClinicalTrials.gov