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T5 Point of care blood eosinophil guided oral prednisolone for COPD exacerbations: a multi-centre double blind randomised controlled trial (The STARR2 trial)
  1. S Ramakrishnan1,2,3,
  2. H Jeffers1,2,
  3. B Langford-Wiley1,2,
  4. J Davies1,
  5. M Mahdi1,2,
  6. C A’Court4,
  7. I Binnian5,
  8. S Bright6,
  9. S Cartwright7,
  10. R Fox8,
  11. REK Russell1,2,
  12. M Bafadhel2,9
  1. 1Oxford NIHR Biomedical Research Centre, University of Oxford, Oxford, UK
  2. 2Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK
  3. 3Edith Cowan University, Perth, Australia
  4. 4Broadshires Health Centre, Carterton, UK
  5. 5Eyensham Medical Group, Eyensham, UK
  6. 6Windrush Medical Practice, Witney, UK
  7. 7White Horse Medical Practice, Faringdon, UK
  8. 8Bicester Health Centre, Bicester, UK
  9. 9School of Immunology and Microbial Sciences, Kings College London, London, UK

Abstract

Introduction and Objectives Prednisolone for COPD exacerbation treatment leads to more patient harm than benefit. Previous work showed that blood eosinophil count directed oral prednisolone was safe and trended towards fewer treatment failures at 28 days after exacerbation. This study aimed to evaluate the efficacy of blood-eosinophil directed corticosteroid therapy using near-patient testing, compared to current standard practice during an exacerbation of COPD in a multi-centre primary care study.

Methods Patients with a COPD exacerbation were recruited from 14 general practices in the Thames Valley. Participants were randomly allocated to receive intervention with eosinophil-biomarker guided matched prednisolone or placebo or standard care (matched prednisolone 30 mg) for 14 days. Participants in the intervention arm with a blood eosinophil count of <2% on point of care testing were treated with blinded placebo. Participants were followed up at day 14, 30 and 90 after randomisation. The primary outcome was the rate of treatment failure, defined as any need for antibiotics and/or steroids at 30 days. Key secondary outcomes include change in COPD assessment test, FEV1 and visual analogue scale of COPD exacerbation symptoms.

Results 203 exacerbations were randomised to eosinophil-biomarker guided (n=102) or standard care (n=101) for management of the exacerbation. There were 25% current smokers (n=50) and 40% were women (n=80) equally distributed between the two study arms. The mean age (range) was 71 (46 to 90). One third of exacerbations (n=34) in the eosinophil-biomarker guided arm were treated with placebo. Intention to treat analysis at day 30 showed that treatment failure occurred in 28 and 34 patients in the eosinophil-biomarker guided and standard care arms respectively (RR 0.82 95% CI 0.54 – 1.23, p=0.34). There were no statistically or clinically meaningful difference in the COPD assessment test, forced expiratory volume in 1 second and the symptom visual analogue scales between participants in the eosinophil-biomarker guided and standard care arms

Conclusion Reduction of prednisolone therapy, using near-patient testing can be safely performed using an eosinophil-biomarker guided approach in primary care for treatment of an exacerbation of COPD. This should become part of clinical practice.

Trial Registration NCT04458636

Please refer to page A208 for declarations of interest related to this abstract.

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