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Near-patient testing to guide COPD maintenance treatment in primary care

Prospective observational cohort study which aims to investigate how various markers and tests might be helpful in establishing which patients with COPD in primary care would most benefit from treatment with steroid inhalers, particularly looking at how these tests vary within and between patients, their feasibility, and how accurate near-patient tests are compared to laboratory tests.

Background

Chronic obstructive pulmonary disease (COPD) is characterised by breathlessness, cough and excess mucus production. It is commonly managed in primary care using inhaled medication, including inhaled corticosteroids (ICS). ICS treatment is 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); another is a breath test called fraction of exhaled nitric oxide (FeNO) which measures airway inflammation. Further analysis of previous trials of ICS has found that broadly there is a greater response to ICS-containing medications in patients who have high blood eosinophil levels before treatment.

The aim of this study is to gather preliminary information to look at whether blood and breath tests could be used 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). We are recruiting patients aged over 40 with COPD who have not recently been prescribed ICS treatment, and carrying out these tests (including blood eosinophils, FeNO, CRP and periostin) on four occasions over a six-month period. We will be assessing how the results vary within and between patients, the feasibility of these tests in primary care, and how accurate near-patient tests are compared to laboratory tests.

Study design:

Prospective observational cohort study

Sponsor:

University of Oxford

Chief Investigator:

Dr Helen Ashdown, University of Oxford

Ethical approval:

REC ref: 16/SS/0135
ISRCTN 12181464 https://www.isrctn.com/ISRCTN12181464

Contact details:

comet@phc.ox.ac.uk

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Trial management team: