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

1 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

300

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Professor Tom M Wilkinson, MBBS PhD FRCP FERS
  • Número de telefone: 02381205341
  • E-mail: t.wilkinson@soton.ac.uk

Estude backup de contato

Locais de estudo

    • Hampshire
      • Andover, Hampshire, Reino Unido, SP10 3LB
        • Hampshire Hospitals NHS Foundation Trust
        • Investigador principal:
          • Harry S Griffin, PhD HCPC
      • Southampton, Hampshire, Reino Unido, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Prazo: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Diagnostic accuracy of oscillometry
Prazo: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Baseline
Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions
Prazo: 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
Prazo: 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
Prazo: Baseline
Time per test of advanced diagnostic technologies compared to usual care
Baseline
Comparative 'failure rate'
Prazo: Baseline
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
Baseline
Usability and acceptability
Prazo: 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
Prazo: Baseline
Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de agosto de 2026

Primeira postagem (Real)

1 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • DEV DVB0067
  • 359125 (Outro identificador: IRAS Number)
  • RHM RSP0030 (Outro identificador: Local Reference Number)
  • 25/NE/0225 (Outro identificador: REC ID)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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