- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07798596
Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings (BREATHE)
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Professor Tom M Wilkinson, MBBS PhD FRCP FERS
- Telefoonnummer: 02381205341
- E-mail: t.wilkinson@soton.ac.uk
Studie Contact Back-up
- Naam: Madison E Geeves, MSc BSc
- E-mail: m.e.geeves@soton.ac.uk
Studie Locaties
-
-
Hampshire
-
Andover, Hampshire, Verenigd Koninkrijk, SP10 3LB
- Hampshire Hospitals NHS Foundation Trust
-
Hoofdonderzoeker:
- Harry S Griffin, PhD HCPC
-
Southampton, Hampshire, Verenigd Koninkrijk, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Tijdsspanne: Baseline
|
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
|
Baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Diagnostic accuracy of oscillometry
Tijdsspanne: Baseline
|
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
|
Baseline
|
|
Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
|
Time per test of advanced diagnostic technologies compared to usual care
|
Baseline
|
|
Comparative 'failure rate'
Tijdsspanne: Baseline
|
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
|
Baseline
|
|
Usability and acceptability
Tijdsspanne: 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
Tijdsspanne: Baseline
|
Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews
|
Baseline
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Chronische ziekte
- Ziekte attributen
- Ziekten van de luchtwegen
- Longziekten
- Longziekten, obstructief
- Pathologische aandoeningen, tekenen en symptomen
- Longziekte, chronisch obstructief
- Diagnostische technieken en procedures
- Diagnose
- Diagnostische technieken, ademhalingssysteem
- Ademhalingsfunctietests
- Spirometrie
- Capnografie
Andere studie-ID-nummers
- DEV DVB0067
- 359125 (Andere identificatie: IRAS Number)
- RHM RSP0030 (Andere identificatie: Local Reference Number)
- 25/NE/0225 (Andere identificatie: REC ID)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .