COMET

  • Research type

    Research Study

  • Full title

    Near-patient testing to guide COPD MaintenancE Treatment in primary care (COMET): observational study to determine variability and accuracy of inflammatory biomarkers in stable state.

  • IRAS ID

    209326

  • Contact name

    Helen Ashdown

  • Contact email

    helen.ashdown@phc.ox.ac.uk

  • Sponsor organisation

    University of Oxford

  • Duration of Study in the UK

    1 years, 5 months, 28 days

  • Research summary

    Chronic obstructive pulmonary disease (COPD) is commonly managed in primary care using inhaled medication, with inhaled corticosteroids (ICS) recommended by NICE guidelines for worsening symptoms or moderate/severe COPD. However, their use can be associated with side-effects such as pneumonia.

    Previous research suggests that patients with COPD vary in terms of markers of inflammation in their blood and breath, and this can affect disease outcomes. One of these markers is the blood eosinophil count (a type of white blood cell). Further analysis of previous trials of ICS has found that broadly there is a greater response to ICS-containing preparations in patients who have a higher blood eosinophil level before treatment. Fraction of exhaled nitric oxide (FeNO) is a breath test which measures eosinophilic inflammation.

    In the future, we would like to look at whether we could use blood and breath tests to predict which patients would most benefit from ICS treatment, and it might be particularly useful to do this if results could be available immediately (near-patient testing). However, these markers and tests have not been looked at in a primary care population to find out how they vary within, and between patients, which is what we would like to assess in this study, funded by the National Institute for Health Research.

    We will ask GPs to invite patients with COPD who are not prescribed an ICS to take part in our study, by postal invitation. We will invite them to attend four research appointments at their local surgery, over a 6 month period (2 months apart). At each appointment we will measure spirometry (lung function), FeNO, finger-prick blood eosinophils, and take a venous (arm) blood test for eosinophils and other relevant markers of inflammation, respiratory symptom questionnaires and (at the final appointment) a survey about acceptability of the tests.

  • REC name

    South East Scotland REC 02

  • REC reference

    16/SS/0135

  • Date of REC Opinion

    18 Aug 2016

  • REC opinion

    Further Information Favourable Opinion