COPDNCT06788613
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.
An observational study of COPD and Emphysema or COPD, run by Chiesi UK.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- COPD, Emphysema or COPD, Emphysema
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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.
Aim: Explore the blood biomarker profile among FRONTIER Programme participants to explore a potential role in early COPD identification.
Objectives:
- 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.
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hull University Teaching Hospitals NHS Trust, TidalSense, Asthma + Lung UK
- Responsible party
- Sponsor
- Investigators
- Micheal Crooks, Prof, Principal investigator, University of HullKaren Watkins, Study chair, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788613
- Sponsor's protocol ID
- Beyond-FRONTIER
- Status last verified
- Jan 2025
- First submitted
- 18 Sep 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06788613
- Acronym / sponsor ID
- Beyond-FRONTIER
- Conditions
- COPD, Emphysema or COPD, Emphysema
- Keywords
- COPD, Hull Lung Health, TidalSense, N-tidal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Chiesi UKIndustry (pharma, biotech, devices)
- Collaborators
- Hull University Teaching Hospitals NHS Trust, TidalSense, Asthma + Lung UK
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To investigate the potential for N-Tidal to improve COPD diagnosis and enable detection of pre-COPD*.
Objectives:
- 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.
Aim: Explore the blood biomarker profile among FRONTIER Programme participants to explore a potential role in early COPD identification.
Objectives:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 1 year
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.
To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.
Time frame: 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 that go onto receive a diagnosis of COPD within 1-year of initial review (Pre COPD).
Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year
Time frame: 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 secondary outcome
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
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Micheal Crooks, Prof principal investigator
University of Hull
Karen Watkins study chair
Hull University Teaching Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Emphysema or COPD, run by Chiesi UK.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Micheal Crooks, Prof (+44 01482 624067, michael.crooks@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.