COPD (Chronic Obstructive Pulmonary Disease)BREATHENCT07798596
Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Airway Disease, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Airway Disease
- What is being tested?
- Capnography, Oscillometry and FENO
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2026to Sep 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- ≥ 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Madison E Geeves, MSc BSc contact
United Kingdom2 sites
Hampshire Hospitals NHS Foundation Trust
Andover, Hampshire, SP10 3LB
Harry S Griffin, PhD HCPC
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: BREATHE: Benchmarking Respiratory Evaluation of Advanced Technologies for Healthcare Excellence
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.
- Being tested
- Capnography, Oscillometry, FENO, Gas Transfer, Static Lung Volumes
- Keywords
- N-Tidal Diagnose, Oscillometry, Clinical Suspicion of COPD, Respiratory Function Test, Physiological Measurement, Airway Disease, Diagnostic Techniques, Clinical Suspicion of Airway Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyDiagnostic test
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
OscillometryDiagnostic test
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing.
FENODiagnostic test
Fractional exhaled nitric oxide (if requested). Used to assess airway inflammation.
Gas TransferDiagnostic test
Assesses lung diffusing capacity, performed using full pulmonary function testing equipment
Static Lung VolumesDiagnostic test
Body plethysmography (if applicable). Used to assess static lung volumes and, where applicable, specific resistance, performed using full lung function equipment
SpirometryDiagnostic test
Spirometry, with or without reversibility testing
| Study group | Role | What they receive |
|---|---|---|
| GP direct access spirometry within community diagnostic centres | Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres Receives: 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 Receives: 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 Receives: Diagnostic Test: Capnography; Diagnostic Test: Oscillometry | |
| Community outreach | Adults with suspected COPD/airway disease attending local community groups and events Receives: Diagnostic Test: Capnography; Diagnostic Test: Oscillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Measured: Baseline
Secondary outcomes (7)
Diagnostic accuracy of oscillometry
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Measured: Baseline
Time per test
Time per test of advanced diagnostic technologies compared to usual care
Measured: Baseline
Comparative 'failure rate'
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
Measured: Baseline
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
Measured: Baseline
Usability and acceptability
Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust, University of Southampton, TidalSense, NIHR Southampton Respiratory Biomedical Research Centre, Restech Srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798596
- Sponsor's protocol ID
- DEV DVB0067
- Other IDs
- 359125, RHM RSP0030, 25/NE/0225
- Acronym
- BREATHE
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared under appropriate governance in accordance with the TidalSense and University Hospital Southampton NHS Foundation Trust agreement
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREATHE: Benchmarking Respiratory Evaluation of Advanced Technologies for Healthcare Excellence
- ClinicalTrials.gov ID
- NCT07798596
- Acronym / sponsor ID
- BREATHE / DEV DVB0067
- Keywords
- N-Tidal Diagnose, Oscillometry, Clinical Suspicion of COPD, Respiratory Function Test, Physiological Measurement, Airway Disease, Diagnostic Techniques, Clinical Suspicion of Airway Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust, University of Southampton, TidalSense, NIHR Southampton Respiratory Biomedical Research Centre, Restech Srl
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 1 Sep 2026 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GP direct access spirometry within community diagnostic centres | – | Diagnostic Test: Capnography, Diagnostic Test: Oscillometry, Diagnostic Test: FENO, Diagnostic Test: SpirometryAdults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres |
| Full lung function testing within secondary care hospitals | – | Diagnostic Test: Capnography, Diagnostic Test: Oscillometry, Diagnostic Test: FENO, Diagnostic Test: Gas Transfer, Diagnostic Test: Static Lung Volumes, Diagnostic Test: SpirometryAdults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals |
| Low dose-CT scan within lung cancer screening programme | – | Diagnostic Test: Capnography, Diagnostic Test: OscillometryAdults with suspected COPD/airway disease attending for a low-dose CT scan as part of the lung cancer screening programme |
| Community outreach | – | Diagnostic Test: Capnography, Diagnostic Test: OscillometryAdults with suspected COPD/airway disease attending local community groups and events |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapnographyCapnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry) | Diagnostic test | 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 |
| OscillometryOscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing. | Diagnostic test | 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 |
| FENOFractional exhaled nitric oxide (if requested). Used to assess airway inflammation. | Diagnostic test | Full lung function testing within secondary care hospitals, GP direct access spirometry within community diagnostic centres |
| Gas TransferAssesses lung diffusing capacity, performed using full pulmonary function testing equipment | Diagnostic test | Full lung function testing within secondary care hospitals |
| Static Lung VolumesBody plethysmography (if applicable). Used to assess static lung volumes and, where applicable, specific resistance, performed using full lung function equipment | Diagnostic test | Full lung function testing within secondary care hospitals |
| SpirometrySpirometry, with or without reversibility testing | Diagnostic test | Full lung function testing within secondary care hospitals, GP direct access spirometry within community diagnostic centres |
Primary outcome
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Time frame: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
7 secondary outcomes
Diagnostic accuracy of oscillometry
Time frame: Baseline
Time per test
Time frame: Baseline
Comparative 'failure rate'
Time frame: Baseline
Usability and acceptability
Time frame: Baseline
Usability and acceptability
Time frame: Baseline
Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions
Time frame: Baseline
Feasibility outcomes in Lung Cancer Screening pathway
Time frame: Baseline
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 4 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data may be shared under appropriate governance in accordance with the TidalSense and University Hospital Southampton NHS Foundation Trust agreement
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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.
Madison E Geeves, MSc BSc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Airway Disease, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
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 11 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Professor Tom M Wilkinson, MBBS PhD FRCP FERS (02381205341, t.wilkinson@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms (time frame: Baseline). 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 4 Sep 2026.