[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576693":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":24,"locations":10,"responsibleParty":32,"collaborators":34,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":10},{"fullName":5,"class":6},"Chiesi UK","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Head-to-head comparison with post-bronchodilator spirometry among FRONTIER programme participants",null,"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.\n2. To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.\n3. Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year.",{"label":13,"type":10,"description":14,"interventionNames":10},"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.\n2. Explore a potential role for blood biomarkers in COPD diagnostics.",[16,20],{"name":17,"affiliation":18,"role":19},"Micheal Crooks, Prof","Hull York Medical School","PRINCIPAL_INVESTIGATOR",{"name":21,"affiliation":22,"role":23},"Karen Watkins","Hull University Teaching Hospitals NHS Trust","STUDY_CHAIR",[25,29],{"name":17,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+44 01482 624067","michael.crooks@nhs.net",{"name":30,"role":26,"phone":27,"phoneExt":10,"email":31},"Kayleigh Brindle","Kayleigh.brindle@nhs.net; karen.watkins14@nhs.net",{"type":33,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[35,37,39],{"name":22,"class":36},"OTHER_GOV",{"name":38,"class":6},"TidalSense",{"name":40,"class":41},"Asthma + Lung UK","UNKNOWN","100576693","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-100576693",false,"NCT06788613","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","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.\n\nProspective consent provided for use of data for research purposes and for future contact as part of the Hull Lung Health Study\n\nInclusion criteria:\n\n* 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:\n* Breathlessness\n* Cough\n* Bronchitis\n* Recurrent infections\n* AND\u002FOR evidence of Emphysema on Low Dose CT\n\nExclusion criteria:\n\n-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.","ALL","55 Years","75 Years",{"count":53,"type":54},1200,"ESTIMATED","OBSERVATIONAL","Aim: To investigate the potential for N-Tidal to improve COPD diagnosis and enable detection of pre-COPD\\*.\n\nObjectives:\n\n1. 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.\n2. To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.\n3. Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year.\n\nAim: Explore the blood biomarker profile among FRONTIER Programme participants to explore a potential role in early COPD identification.\n\nObjectives:\n\n1. 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.\n2. Explore a potential role for blood biomarkers in COPD diagnostics.\n\n   * Pre-COPD is defined, as per the GOLD Report 2023, as individuals who have respiratory symptoms and\u002For other detectable structural and\u002For 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",[58,59,60],"COPD","Emphysema or COPD","Emphysema",[58,62,38,63],"Hull Lung Health","N-tidal","NOT_YET_RECRUITING","2025-05-30",{"date":67,"type":68},"2025-05-31","ACTUAL",{"date":70,"type":54},"2025-08",{"date":72,"type":54},"2026-09-30",{"name":5,"class":6}]