The TRACE-COPD trial
Research type
Research Study
Full title
Chracterisation and targeted TReatment of ACute Exacerbations of Chronic Obstructive Pulmonary Disease. The TRACE-COPD Randomised Controlled Trial.
IRAS ID
248241
Contact name
Jørgen Vestbo
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
ISRCTN Number
ISRCTN00000000
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Acute exacerbations of COPD (AECOPD) are symptom flare-ups causing poor health, hospitalisation or death and they are responsible for 1:8 hospital admissions in the UK. AECOPD are managed by inhaled drugs to open-up the airways, systemic steroids to treat inflammation and almost invariably antibiotics to treat bacterial infections. However, only 50% of AECOPD that are caused by bacteria (bugs) respond to antibiotics and only 30-50% that are caused by inflammation of the airways with eosinophils respond to systemic steroids. Therefore, both medications are currently overused, posing unnecessary risks to patients with COPD. For instance, steroids can cause infections, fractures or muscle wasting, while overuse of antibiotics can lead to the development of super-bugs.
Previous studies have suggested that a biomarker in the blood, procalcitonin (PCT), can point out AECOPD responding to antibiotics and a subgroup of white blood cells, the blood eosinophil count (EOS), can identify those responding to systemic steroids. This provides a potential opportunity to personalise the management of AECOPD, which could lead to improved use of healthcare resources and reduction in the frequency of side effects and antibiotic burden (the development of super-bugs).
We will set up a controlled clinical trial to assess whether the combination of procalcitonin and EOS can identify moderate or severe AECOPD associated with bacterial infection or EOS airway inflammation and can safely and effectively decrease and target the administration of antibiotics and/or steroids. Approximately half of the participants will be recruited in the hospital and the remaining in the community. All participants will be monitored for six months after the AECOPD.
As this is the first trial assessing this biomarker combination, we will only recruit 135 participants to get an insight into the effects of the intervention and information that we need to launch a larger, confirmatory trial in the future.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0710
Date of REC Opinion
21 Nov 2018
REC opinion
Further Information Favourable Opinion