An observational study in COPD, Emphysema or COPD and Emphysema, sponsored by Chiesi UK. Not yet recruiting. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Chiesi UK (part of Chiesi Farmaceutici S.p.A.) · Observational
Aim: To investigate the potential for N-Tidal to improve COPD diagnosis and enable detection of pre-COPD*.
Objectives:
Aim: Explore the blood biomarker profile among FRONTIER Programme participants to explore a potential role in early COPD identification.
Objectives:
Explore a potential role for blood biomarkers in COPD diagnostics.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Chiesi UK is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion criteria:
-Existing diagnosis noted at the time of their Lung Health Check or new COPD diagnosis since Lung Health Check attendance AND prescribed appropriate COPD therapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 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).
Time frame: 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
Time frame: 1 year
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.
Time frame: 1 year
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →