Point of care testing in the diagnosis and management of COPD
Research type
Research Study
Full title
Point of care testing in the diagnosis and management of chronic obstructive pulmonary disease
IRAS ID
184342
Contact name
Sadiyah Hand
Contact email
Sponsor organisation
Cwm Taf University Health Board
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
COPD is a high-prevalence, chronic respiratory condition associated with high costs to the NHS, both in terms of medication and hospital admissions with exacerbations. Early diagnosis of COPD improves patient management and quality of life. Early treatment of exacerbations of COPD is associated with improved outcomes and reduced risk of admission and therefore reduced cost.
Swansea University and Glyconics Ltd (funded through an SBRI contract) have developed a technique using laboratory based infrared spectroscopy to analyse the levels of sugars (glycosylation) attached to proteins called mucins that are the major molecule in sputum and found levels of glycosylation correlate with COPD disease. Additional changes to the structure of these mucin sugars could be associated with exacerbations. Glyconics have adapted their technique to use with hand-held devices and envisage providing point-of-care testing equipment to detect exacerbations of COPD prior to development of clinical symptoms.
By analyzing mucin glycosylation changes can infrared spectroscopy diagnose COPD and can a hand-held version of the technology detect further mucin structural changes between baseline and an exacerbation of COPD before clinical signs become evident?The technology will be evaluated in two sub-studies:
a) A longitudinal cohort will provide daily sputum samples and symptom questionnaires over 12 months and these will be analysed with data on timings and occurrences of exacerbations (Study A)
b) A case-control study will provide a single sputum sample from cases either with a new diagnosis of COPD (disease group) or cases who are smokers but do not have a clinical diagnosis of COPD (control group). (Study B).
For both studies, sputum samples will be processed in a blinded manner on both the handheld (Point of care testing device) and full sized spectrometer. Clinicians and the research team will not have access to sputum results or other data during the course of the study.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1703
Date of REC Opinion
28 Oct 2015
REC opinion
Further Information Favourable Opinion