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

1 września 2026 zaktualizowane przez: University Hospital Southampton NHS Foundation Trust

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

300

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Hampshire
      • Andover, Hampshire, Zjednoczone Królestwo, SP10 3LB
        • Hampshire Hospitals NHS Foundation Trust
        • Główny śledczy:
          • Harry S Griffin, PhD HCPC
      • Southampton, Hampshire, Zjednoczone Królestwo, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

Inclusion Criteria:

  • ≥ 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)

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
GP direct access spirometry within community diagnostic centres
Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing.
Fractional exhaled nitric oxide (if requested). Used to assess airway inflammation.
Spirometry, with or without reversibility testing
Full lung function testing within secondary care hospitals
Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing.
Fractional exhaled nitric oxide (if requested). Used to assess airway inflammation.
Spirometry, with or without reversibility testing
Assesses lung diffusing capacity, performed using full pulmonary function testing equipment
Body plethysmography (if applicable). Used to assess static lung volumes and, where applicable, specific resistance, performed using full lung function equipment
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
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing.
Community outreach
Adults with suspected COPD/airway disease attending local community groups and events
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Ramy czasowe: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Baseline

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Diagnostic accuracy of oscillometry
Ramy czasowe: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Baseline
Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions
Ramy czasowe: Baseline
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
Baseline
Feasibility outcomes in Lung Cancer Screening pathway
Ramy czasowe: Baseline
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
Baseline
Time per test
Ramy czasowe: Baseline
Time per test of advanced diagnostic technologies compared to usual care
Baseline
Comparative 'failure rate'
Ramy czasowe: Baseline
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
Baseline
Usability and acceptability
Ramy czasowe: Baseline
Patients' perceptions on the usability and acceptability of advanced respiratory diagnostic technologies compared to existing tests such as spirometry via a non-validated questionnaire
Baseline
Usability and acceptability
Ramy czasowe: Baseline
Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews
Baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2027

Ukończenie studiów (Szacowany)

1 września 2029

Daty rejestracji na studia

Pierwszy przesłany

24 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

1 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

Data may be shared under appropriate governance in accordance with the TidalSense and University Hospital Southampton NHS Foundation Trust agreement

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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