Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings

NCT07798596 | Not Yet Recruiting

• 4 other identifiers: DEV DVB0067359125RHM RSP003025/NE/0225
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Airway disease, such as chronic obstructive pulmonary disease (COPD), is usually diagnosed through breathing tests like spirometry. However, it requires people to blow forcefully into a machine several times which can be uncomfortable and difficult for some patients. This study is looking at whether newer technologies and other breathing tests can help diagnose COPD as accurately as standard testing. We will compare these tests in both hospital and community settings. We are interested in understanding how practical and cost-effective these tests are, including how easy they are to use and how comfortable they are for patients to perform.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Airway Disease

Keywords

N-Tidal Diagnose; Oscillometry; Clinical Suspicion of COPD; Respiratory Function Test; Physiological Measurement; Airway Disease; Diagnostic Techniques; Clinical Suspicion of Airway Disease

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms

  Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD

  Baseline

Secondary Outcomes (7)

• Diagnostic accuracy of oscillometry

  Baseline

• Time per test

  Baseline

• Comparative 'failure rate'

  Baseline

• Usability and acceptability

  Baseline

• Usability and acceptability

  Baseline

Study Arms (4)

GP direct access spirometry within community diagnostic centres

Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres

Diagnostic Test: Capnography; Diagnostic Test: Oscillometry; Diagnostic Test: FENO; Diagnostic Test: Spirometry

Full lung function testing within secondary care hospitals

Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals

Diagnostic Test: Capnography; Diagnostic Test: Oscillometry; Diagnostic Test: FENO; Diagnostic Test: Gas Transfer; Diagnostic Test: Static Lung Volumes; Diagnostic Test: Spirometry

Low dose-CT scan within lung cancer screening programme

Adults with suspected COPD/airway disease attending for a low-dose CT scan as part of the lung cancer screening programme

Diagnostic Test: Capnography; Diagnostic Test: Oscillometry

Community outreach

Adults with suspected COPD/airway disease attending local community groups and events

Diagnostic Test: Capnography; Diagnostic Test: Oscillometry

Interventions

Capnography DIAGNOSTIC_TEST

Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)

Community outreach; Full lung function testing within secondary care hospitals; GP direct access spirometry within community diagnostic centres; Low dose-CT scan within lung cancer screening programme

Oscillometry DIAGNOSTIC_TEST

Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing.

Community outreach; Full lung function testing within secondary care hospitals; GP direct access spirometry within community diagnostic centres; Low dose-CT scan within lung cancer screening programme

FENO DIAGNOSTIC_TEST

Fractional exhaled nitric oxide (if requested). Used to assess airway inflammation.

Full lung function testing within secondary care hospitals; GP direct access spirometry within community diagnostic centres

Gas Transfer DIAGNOSTIC_TEST

Assesses lung diffusing capacity, performed using full pulmonary function testing equipment

Full lung function testing within secondary care hospitals

Static Lung Volumes DIAGNOSTIC_TEST

Body plethysmography (if applicable). Used to assess static lung volumes and, where applicable, specific resistance, performed using full lung function equipment

Full lung function testing within secondary care hospitals

Spirometry DIAGNOSTIC_TEST

Spirometry, with or without reversibility testing

Full lung function testing within secondary care hospitals; GP direct access spirometry within community diagnostic centres

Eligibility Criteria

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

Study Population

Adults with a clinical suspicion of COPD/airway disease referred for spirometry testing at local community diagnostic centres or for lung function testing at secondary care hospitals. Additionally, adults attending for a low-dose CT scan as part of the lung cancer screening programme or adults attending local community groups or events

You may qualify if:

• ≥ 18 years of age
• New referral to community or secondary healthcare services
• Clinical suspicion of airway disease/COPD
• Able to provide fully informed written consent
• Able to fully understand and cooperate with the study protocol
• Clinically stable with no contraindications to lung function testing (outlined below)

You may not qualify if:

• Confirmed diagnosis of COPD
• Not willing and/or able to provide fully informed written consent to participate
• Has a relative contraindication to lung function testing \[18\]:
• Recent thoracic, abdominal or eye (e.g. cataract) surgery \< 6 weeks
• Unstable cardiovascular status, including recent myocardial infarction or pulmonary embolus \< 6 weeks
• Pneumothorax \< 6 weeks
• Haemoptysis of unknown origin \< 6 weeks
• Thoracic, abdominal or cerebral aneurysm
• Chest infection \< 6 weeks
• An acute illness or symptom that might interfere with test performance (e.g. nausea, vomiting).
• The presence of any other clinical condition that would prevent the individual from safely performing lung function tests

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Hampshire Hospitals NHS Foundation Trust: collaborator
• University of Southampton: collaborator
• TidalSense: collaborator
• NIHR Southampton Respiratory Biomedical Research Centre: collaborator
• Restech Srl: collaborator

Study Sites (2)

Hampshire Hospitals NHS Foundation Trust

Andover, Hampshire, SP10 3LB, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Capnography; Spirometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Professor Tom M Wilkinson, MBBS PhD FRCP FERS

CONTACT

02381205341; t.wilkinson@soton.ac.uk

Madison E Geeves, MSc BSc

CONTACT

m.e.geeves@soton.ac.uk

Study Design

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

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09

Locations

GB (2)