Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres
BPAP
1 other identifier
observational
276
1 country
8
Brief Summary
Retrospective secondary data collection observational chart review study. Data collection and analysis will be performed on a cohort of patients who have previously been enrolled on the BPAP. Approximately 300 patients taking part in the BPAP between April 2018 and November 2019 and who meet the eligibility criteria will be recruited to participate in the study. Data for each participant in the study will be obtained retrospectively with a focus on obtaining data at baseline (12 months prior to first benralizumab dose or at first assessment in the severe asthma center if \<12 months), Index date (date of first benralizumab dose) and at least up to 24 months after index date. Primary Objectives
- To describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients enrolled in the BPAP
- To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation Secondary Objectives:
- To describe clinical outcomes after initiation of benralizumab therapy in severe eosinophilic asthma patients treated with benralizumab at 12 and 24 months
- To describe patients' adherence to benralizumab, persistence and discontinuation rates and reasons for discontinuation at 12 and 24 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedFirst Submitted
Initial submission to the registry
June 28, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedNovember 28, 2023
November 1, 2023
5 months
June 28, 2023
November 22, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Baseline annual exacerbation rate
Baseline frequency and annualized rate of asthma exacerbations by severity levels
-12 to 0 months
Maintenance OCS dose during baseline
Maintenance OCS: frequency of patients on mOCS, dosage (for patients on mOCS), annualized cumulative dose
-12 to 0 months
Secondary Outcomes (14)
Annualised exacerbation rate (AER)
12 months
Annualised exacerbation rate (AER)
24 months
FEV1
12 months
FEV1
24 months
ACQ-6
12 months
- +9 more secondary outcomes
Interventions
Patients were initiated on benralizumab as part of routine clinical practice
Eligibility Criteria
Severe eosinophilic asthma patients enrolled in the benralizumab patient access programme in UK severe centres. Patients will have had their first benralizumab dose between April 2018 and November 2019 and data will be collected retrospectively between May 2019 and October 2021.
You may qualify if:
- Patients enrolled on the BPAP between April 2018 and November 2019
- Patients who have at least 1 benralizumab injection and with at least 3 months followup data from the time of enrolment into the BPAP
- Patients initiated on benralizumab outside of the BPAP by October 30, 2019.
- Where CRO employees conduct the data extraction, patients must be able and willing to give informed consent to participate in the study
You may not qualify if:
- Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
- Refusal or inability to provide informed consent where the CRO will be collecting the data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Addenbrookes Hospital
Cambridge, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Guy's Hospital
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David J Jackson, MRCP MSc PhD
Guy's & St Thomas' NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2023
First Posted
July 6, 2023
Study Start
October 5, 2021
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
November 28, 2023
Record last verified: 2023-11