Acute exacerbations treated with BenRAlizumab (The ABRA study)
Research type
Research Study
Full title
The use of Benralizumab, an interleukin-5 receptor-α monoclonal antibody as treatment of acute exacerbations of airways disease
IRAS ID
249196
Contact name
Mona Bafadhel
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Eudract number
2018-004401-79
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 8 days
Research summary
Acute exacerbations of asthma and COPD are an important cause of hospital admission and the main cause of annual winter bed shortages; constituting the majority of asthma and COPD exacerbations. Despite current guideline recommendations, treatment with oral corticosteroids (for both asthma and COPD exacerbations) and antibiotics (for COPD exacerbations associated with sputum purulence) is not wholly adequate. Evidence suggests that 40% of patients require further treatment or re-treatment, 15% are readmitted and of those hospitalised with an exacerbation of COPD, 10% die within 3 months. The risk of death in patients with asthma is especially high in those who have poorly controlled asthma. These events are all by definition treatment failures or non-response and impact on patient outcomes. In patients with COPD the outlook is particularly bleak in patients following a second hospital admission with a significant increase in mortality.
We are proposing to test the hypothesis that comparing the standard treatment of Prednisolone, with an addition of a single injection of Benralizumab given at the time of a participants an exacerbation who also has a raised blood eosinophil count will increase the rate of recovery and reduces the rate of treatment failure. We will carry out a three way parallel group study comparing both Benralizumab as a single dose and oral prednisolone daily for 5 days; Benralizumab as a single dose and oral placebo daily for 5 days; and Placebo injection and oral prednisolone daily for 5 days.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0187
Date of REC Opinion
15 Apr 2020
REC opinion
Further Information Favourable Opinion