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 | Not Yet Recruiting

• 1 other identifier: Beyond-FRONTIER
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: To investigate the potential for N-Tidal to improve COPD diagnosis and enable detection of pre-COPD\*. Objectives:

1. 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. 2.To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.
3. 3.Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year.
4. 4.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.
5. 5.Explore a potential role for blood biomarkers in COPD diagnostics.
6. 6.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

Keywords

COPD; Hull Lung Health; TidalSense; N-tidal

Outcome Measures

Primary Outcomes (3)

• 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 (NHS Lung Health Check) participants.

  We will investigate the performance of TidalSense COPD Diagnostic Algorithms (including the sensitivity, specificity, positive predictive value and negative predictive value of TidalSense 'likely' or 'highly likely' outputs) for COPD diagnosis in a real-world, head-to-head comparison with post-bronchodilator spirometry among NHS Lung Health Check participants. It is anticipated that \~900 patients will participate in the programme.

  1 year

• To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.

  We will investigate the sensitivity, specificity, positive predictive value and negative predictive value of TidalSense 'likely' or 'highly likely' outputs for identifying those that go onto receive a diagnosis of COPD within 1-year of initial review (Pre COPD).

  1 year

• Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year

  We will investigate the sensitivity, specificity, positive predictive value and negative predictive value of TidalSense 'likely' or 'highly likely' outputs for identifying those at risk of developing COPD within 1-year

  1 year

Secondary Outcomes (1)

• Explore a potential role for blood biomarkers in COPD diagnostics including investigating 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

  1 year

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hull Lung Health Study participants that take part in the FRONTIER Programme will be included in this study. The FRONTIER Programme is a Collaborative Working Project between the NHS (Hull University Teaching Hospitals NHS Trust) and Chiesi LTD. It aims to enable early COPD diagnosis and timely initiation of evidence-based pharmacological and non-pharmacological interventions to improve outcomes for participants of the Hull Lung Health Check Programme, and the linked Hull Lung Health Study, that missed out on spirometry during their initial Lung Health Check due to infection control precautions

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi UK: lead
• Hull University Teaching Hospitals NHS Trust: collaborator
• TidalSense: collaborator
• Asthma + Lung UK: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood biomarker profiles (obtained from the Hull Lung Health Study data) of people with i) confirmed COPD, ii) pre-COPD, and iii) no evidence of COPD will be investigated to explore a potential role for blood biomarkers in COPD diagnostics.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Micheal Crooks, Prof

  Hull York Medical School

  PRINCIPAL INVESTIGATOR

• Karen Watkins

  Hull University Teaching Hospitals NHS Trust

  STUDY CHAIR

Central Study Contacts

Micheal Crooks, Prof

CONTACT

+44 01482 624067; michael.crooks@nhs.net

Kayleigh Brindle

CONTACT

+44 01482 624067; Kayleigh.brindle@nhs.net; karen.watkins14@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: January 23, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share