Early COPD characterisation and biomarker evaluation (Version 1)
Research type
Research Study
Full title
Characterisation of early COPD patients and pilot evaluation of a novel biomarker
IRAS ID
114164
Contact name
Robert Stockley
Contact email
Sponsor organisation
Head of Research and Development Governance Queen Elizabeth Hospital Birmingham
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease that causes difficulty with breathing. It is a major healthcare problem in the UK. There is no cure for COPD, therefore early identification and prevention of progression, remains the best strategy to reduce the numbers of patients presenting later in life with more severe disease.\n\nOur previous work in primary care identified patients with symptoms of COPD, in whom screening breathing tests were normal. It is known that a lot of damage has to occur before these breathing tests become abnormal compared to the general population. This study aims to try and see how many patients this might apply to; so that we can plan a further large scale study to see if we can identify and manage these patients better.\n\nA biomarker is a simple test (usually a blood test) that identifies patients with disease. We have developed a biomarker that seems to be good at picking up patients who have early COPD. In this pilot study, we are aiming to recruit 100 patients identified in primary care with symptoms suggestive of COPD. Patients will be reviewed at the University Hospital Birmingham where they will be asked to fill in questionnaires and a full clinical history and examination will be performed. A sample of sputum will be collected (if available) and patients will undergo breathing tests, high resolution CT scan of the chest and have a blood test to assess the biomarker. Other non-invasive clinical tests will be performed to identify other medical problems that can be associated with COPD. \n\nThe aim of doing this is to establish how many people have evidence of lung damage on their scan despite having normal breathing tests and confirm if the biomarker test is useful for identifying these patients with early disease before it progresses.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0163
Date of REC Opinion
17 Jun 2013
REC opinion
Further Information Favourable Opinion