Observational study of benralizumab in UK patients with severe asthma
Research type
Research Study
Full title
Benralizumab Patient Access Programme Study: Retrospective, observational study in UK severe asthma centres to describe patient characteristics, treatment patterns and outcomes
IRAS ID
265439
Contact name
David Jackson
Contact email
Sponsor organisation
AstraZeneca
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
This is a multi-centre, observational, secondary data collection study. This study will be conducted in 9 severe asthma centres in the UK.
The overall aim of the study is to better understand the population of patients who received treatment with a drug called benralizumab for severe asthma as part of an early patient access programme (the Benralizumab Patient Access Programme [‘BPAP’]). The BPAP initiative was designed to make benralizumab available to patients with a specific type of asthma (severe eosinophilic asthma) whose symptoms were not well-controlled on standard therapy, to provide treatment options while waiting for benralizumab to be approved and funded for use in the NHS. As well as describing the patients who received benralizumab, this study also aims to find out how the drug was used in the BPAP and how well it worked. The results will provide doctors and nurses with important evidence of benralizumab use and outcomes in the real-world and help to guide its future use.
The study is based on retrospective collection of data from patients’ medical records. Data will be collected either by an external researcher (with patient consent) or the direct care team, for the 12-months before the first benralizumab dose and for up to 12-months afterwards. Data collected will relate to the patients’ characteristics, the frequency of hospital or GP surgery visits, number of asthma exacerbations (flares) and clinical and patient-reported outcomes. There will be no changes to patient management for the study and no requirement for additional tests, investigations or visits.
The population for this study is adult patients diagnosed with severe eosinophilic asthma who received treatment with benralizumab as part of the BPAP. The study is expected to include approximately 200 patients who were enrolled in BPAP between April 2018 and May 2019 and who meet the eligibility criteria.REC name
London - Bloomsbury Research Ethics Committee
REC reference
19/LO/0886
Date of REC Opinion
30 May 2019
REC opinion
Further Information Favourable Opinion