Studying Acute Exacerbations and Response: The COPD STARR 2 study
Research type
Research Study
Full title
Delivering personalised care in the management of exacerbations of chronic obstructive pulmonary disease: A multi-centre randomised clinical trial
IRAS ID
223557
Contact name
Mona Bafadhel
Contact email
Sponsor organisation
University of Oxford
Eudract number
2017-001586-24
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Research Summary
Chronic obstructive pulmonary disease (COPD) affects adults and is largely caused by cigarette smoke in the developed world. It is predicted to be the 3rd leading cause of death by 2020 affecting over 250 million people worldwide.
COPD is characterised by progressive airflow obstruction punctuated by frequent periods of worsening in respiratory symptoms and function associated with a significant impact on quality of life. These episodes are termed exacerbations and current treatment strategies rely on oral corticosteroids (prednisolone) and antibiotics but this is in a "one size fits all" approach. However there is little evidence supporting this strategy and both treatments can potentially cause harm. In addition to this, previous findings have shown that eosinophil counts within blood samples from COPD patients can be used as a biomarker to determine treatment with oral steroids. We believe that personalising this treatment approach during an exacerbation of COPD, to direct whether corticosteroids is necessary for all patients, depending on the results of the eosinophil count from near-patient testing, is superior to current standard treatment strategies in the primary care setting.STARR 2 will be recruiting 228 participants with COPD from GP surgeries within the Thames Valley and South Midlands. A participant's involvement will last up until 12 months and will involve up to 5 visits. These visits will consist of CRF completion, questionnaires, breathing tests, urine testing, blood samples and spirometry. Participants will only be taking the trial drugs for 14 days during an exacerbation.
Summary of Results
The studying acute exacerbations and response (STARR2) study is a multicentre, double-blind, placebo-controlled randomised trial, conducted in primary care practices in the UK, which used a point-of-care testing of blood eosinophil count to guide prednisolone use in patients with an exacerbation of COPD. Our results showed that blood-eosinophil guided therapy was non-inferior to standard care with a lower cumulative oral prednisolone dose; with no clinical or statistically significant difference in lung function, symptom, or quality of life recovery, despite 30% of participants being treated with placebo for their exacerbation. Biomarker-based subgroup analysis also showed that the greatest benefit in lung function and COPD specific quality life was in participants with a high eosinophil count receiving prednisolone.
The blood eosinophil count identifies patients who would benefit from systemic glucocorticoids and helps reduce the systemic exposure and toxicity of universal prednisolone therapy. This study also suggests that the widespread use of COPD rescue packs containing prednisolone, self-initiated by patients at the onset of an exacerbation, might be driving increased harm. Health systems need to encourage systematic assessment of COPD exacerbations to provide patients with the right therapy in a precision biomarker-directed way.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1135
Date of REC Opinion
27 Jul 2017
REC opinion
Favourable Opinion