Endotypes in highly symptomatic COPD
Research type
Research Study
Full title
The Investigation of Endotypes within a Cohort of Highly Symptomatic COPD patients
IRAS ID
215450
Contact name
S Dave Singh
Contact email
Sponsor organisation
Medicines Evaluation Unit Ltd
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
COPD is characterised by a gradual decline in lung function, shortness of breath, wheeze and a daily cough productive of phlegm. Exacerbations are a common problem of COPD and means worsening of symptoms that requires the use of antibiotics, prednisolone (steroid tablets), changes in medication or possibly hospital admission.\nSeveral subgroups of COPD are now known to exist both when the patient is stable (not suffering an exacerbation) or during an exacerbation. The aim of this study is to further improve our understanding of COPD and the different subgroups that exist. Patients often exhibit more than one subgroup; examples include eosinophilic inflammation, bacterial colonisation, emphysema and systemic inflammation. The principal subgroups of interest being eosinophilic inflammation and bacterial colonisation. In this study we will investigate the stability of these subgroups of COPD and the biological markers associated with these subgroups both when the patient is stable and when they have a worsening of their COPD symptoms (an exacerbation). To achieved this a number of assessments will be performed on a group of highly symptomatic COPD patients - blood sampling, sputum induction, pulmonary measurements, questionnaires and activity testing. 70 patients will be enrolled onto the study which will involve 3 visits approximately 3 months apart, over a 6 month period. Patient may return for extra visits (maximum of 4 visits) to provide sputum (phlegm) samples if not enough sputum was collected at previous visits. Subjects will be encourage to attend the unit during their 6 month study period if they experience an exacerbation so that they can be assessed and treated, and to return for a 2 week and 6 week follow up visit. The future of COPD drug treatment is likely to be an subgroup targeted approach.
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0836
Date of REC Opinion
13 Dec 2016
REC opinion
Further Information Favourable Opinion