ClinicalTrials.gg
RecruitingNCT07798596BREATHEUpdated Oct 27, 2026

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

An observational study in COPD (Chronic Obstructive Pulmonary Disease) and Airway Disease, sponsored by University Hospital Southampton NHS Foundation Trust. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by University Hospital Southampton NHS Foundation Trust · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 27, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Long-term lung conditions such as COPD affect around one in five people and are the third leading cause of death in England. These conditions are often not picked up until they have reached an advanced stage, and sometimes people are given an incorrect diagnosis. They cause breathing difficulties due to lung damage, which cannot be reversed in the case of COPD.

At present, lung conditions are usually diagnosed through breathing tests like spirometry. These tests require people to blow forcefully into a machine several times, which can be uncomfortable and difficult for some patients. They also rely on specialist equipment and must be carried out and interpreted by highly trained professionals. Because there aren't enough of these professionals, waiting lists can be long. Even when spirometry is possible, it does not always detect lung disease early.

Two national NHS programmes - the Community Diagnostic Centre (CDC) programme and the Lung Cancer Screening (LCS) programme - create opportunities to find lung disease earlier. However, the same challenges with spirometry remain.

Recently, new types of lung tests have been developed. These tests may be simpler, quicker, and cheaper to use, but they are not yet part of standard NHS care. We need to find out whether these new tests can identify lung disease as well as, or better than, spirometry, especially at earlier stages. If they can, they may help prevent further lung damage and improve health outcomes. It is also important to understand how practical and cost-effective these tests are, and whether they could be used widely in different healthcare settings.

To explore this, we will carry out the new tests alongside traditional lung function tests in both community and hospital settings. We will invite adults with possible COPD who:

  • have been referred for spirometry at local CDCs,
  • have been referred for lung function testing at secondary care hospitals,
  • are attending for a lung scan as part of the LCS pathway, and
  • are attending local community groups or events.

Participants may also be asked to complete short surveys or optional interviews to share their experiences. Healthcare professionals working in testing centres will be invited to do the same. We are especially keen to hear from people who live with lung conditions or who experience health inequalities, so that we can understand how easy the tests are to use, how comfortable they are, and whether they could work well across different healthcare settings.

02

Conditions studied

  • 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
03

In context

Pulmonary Disease, Chronic Obstructive

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 300 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

University Hospital Southampton NHS Foundation Trust is the lead sponsor of 150 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Confirmed diagnosis of
  • Not willing and/or able to provide fully informed written consent to participate
  • Has a relative 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
Terms in these criteria, in plain language(2)

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testCapnography

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

  • Diagnostic testOscillometry

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

  • Diagnostic testFENO

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

  • Diagnostic testGas Transfer

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

  • Diagnostic testStatic Lung Volumes

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

  • Diagnostic testSpirometry

    Spirometry, with or without reversibility testing

06

What researchers measure

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

    Time frame: Baseline

Secondary outcomes

  1. Diagnostic accuracy of oscillometry

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

    Time frame: Baseline

  2. Time per test

    Time per test of advanced diagnostic technologies compared to usual care

    Time frame: Baseline

  3. Comparative 'failure rate'

    Comparative 'failure rate' of advanced diagnostic technologies compared to usual care

    Time frame: Baseline

  4. Usability and acceptability

    Patients' perceptions on the usability and acceptability of advanced respiratory diagnostic technologies compared to existing tests such as spirometry via a non-validated questionnaire

    Time frame: Baseline

  5. Usability and acceptability

    Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews

    Time frame: Baseline

  6. Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions

    Identification of pre-COPD using advanced respiratory diagnostic technologies in patients with normal forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) ratio on spirometry but signs of reduced FEV1, gas trapping, hyperinflation, or reduced diffusing capacity on additional lung function tests performed in secondary care, or emphysema on CT scan. Differentiation of COPD from asthma using advanced diagnostic tests, particularly in patients presenting with overlapping respiratory symptoms

    Time frame: Baseline

  7. Feasibility outcomes in Lung Cancer Screening pathway

    Recruitment uptake rate, time required and the acceptability to both patients and healthcare professional to complete additional diagnostic testing in individuals invited for low-dose CT (LDCT) as part of the lung cancer screening (LCS) pathway

    Time frame: Baseline

07

Study locations

1 of 2 sites recruiting
  • Hampshire Hospitals NHS Foundation Trust
    Andover, Hampshire SP10 3LB, United Kingdom
    Recruiting
    • Harry S Griffin, PhD HCPC · Principal investigator
  • University Hospital Southampton NHS Foundation Trust
    Southampton, Hampshire SO16 6YD, United Kingdom
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Data may be shared under appropriate governance in accordance with the TidalSense and University Hospital Southampton NHS Foundation Trust agreement

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 27, 2026
Sites
2 sites changed recruiting status (1 now recruiting, 1 now not yet recruiting)
Show 2 sites
  • Hampshire Hospitals NHS Foundation Trust · Andover, United Kingdomno status→Recruiting
  • University Hospital Southampton NHS Foundation Trust · Southampton, United Kingdomno status→Not yet recruiting
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Not yet recruiting→Recruiting
    2 sites changed recruiting status (1 now recruiting, 1 now not yet recruiting)
    Show 2 sites
    • Hampshire Hospitals NHS Foundation Trust · Andover, United Kingdomno status→Recruiting
    • University Hospital Southampton NHS Foundation Trust · Southampton, United Kingdomno status→Not yet recruiting
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07798596
Collaborators
Hampshire Hospitals NHS Foundation Trust, University of Southampton, TidalSense, NIHR Southampton Respiratory Biomedical Research Centre, Restech Srl
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Sep 2, 2026
Primary completion
Sep 2027 (estimated)
Completion
Sep 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

Professor Tom M Wilkinson, MBBS PhD FRCP FERS
Contact
t.wilkinson@soton.ac.uk
02381205341
Madison E Geeves, MSc BSc
Contact
m.e.geeves@soton.ac.uk

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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