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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Emphysema; COPD; Emphysema or COPD

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Micheal Crooks, Prof; Phone Number: +44 01482 624067; Email: michael.crooks@nhs.net
• Study Contact Backup: Name: Kayleigh Brindle; Phone Number: +44 01482 624067; Email: Kayleigh.brindle@nhs.net; karen.watkins14@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Head-to-head comparison with post-bronchodilator spirometry among FRONTIER programme participants; 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.; To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.; 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; 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.; Explore a potential role for blood biomarkers in COPD diagnostics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	blood biomarker profiles (eosinophils, nTProBNP, fibrinogen, CRP, and IL-6) will be reported descriptively for those with confirmed COPD, pre-COPD and no COPD. Initial univariable pre-screening will inform variable inclusion in a multivariable logistic regression model to explore factors associated with COPD and pre-COPD diagnosis. Identified associated factors will be considered for inclusion in Tidalsense's diagnostic algorithms and the impact on performance investigated.	1 year

Collaborators and Investigators

• Sponsor: Chiesi UK
• Collaborators: Hull University Teaching Hospitals NHS Trust; TidalSense; Asthma + Lung UK
• Investigators: Principal Investigator: Micheal Crooks, Prof, Hull York Medical School; Study Chair: Karen Watkins, Hull University Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Hull Lung Health; TidalSense; N-tidal
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: Beyond-FRONTIER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical and COPD status data will be retained within the Hull Lung Health Study dataset (held by Hull University Teaching Hospitals NHS Trust) prior to pseudonymisation and transfer to the University of Hull Data Safe Haven. N-Tidal data will be pseudonymised at the point of collection and transferred to the TidalSense cloud where it will be analysed and held by TidalSense. Hull Lung Health Study Data will be available for external research purposes via application to the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No