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Benralizumab Patient Access Programme Study: Retrospective, Observational Study in UK Severe Asthma Centres to Describe Patient Characteristics, Treatment Patterns and Outcomes
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
Age
All ages
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 5, 2021
Primary Completion Date
February 28, 2022
Completion Date
February 28, 2022
Last Updated
November 28, 2023
276
ACTUAL participants
Benralizumab
DRUG
Lead Sponsor
AstraZeneca
NCT07486401
NCT07219173
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02327897