Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres
- Conditions
- Asthma
- Registration Number
- NCT05932849
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline annual exacerbation rate -12 to 0 months Baseline frequency and annualized rate of asthma exacerbations by severity levels
Maintenance OCS dose during baseline -12 to 0 months Maintenance OCS: frequency of patients on mOCS, dosage (for patients on mOCS), annualized cumulative dose
- Secondary Outcome Measures
Name Time Method Annualised exacerbation rate (AER) 24 months AER at 24 months
FEV1 24 months change in lung function from baseline
AQLQ(S)+12 24 months Change in asthma quality of life (AQLQ) from baseline
ACQ-6 24 months Change in asthma control (ACQ-6) score from baseline
Eosinophil count 24 months Mean change in eosinophil count from baseline
mOCS dose 24 months Percentage change in daily OCS dose, Percentage of patients with OCS \<=5mg/day (only for those patients that at baseline had a daily dose \>5mg/d)
Treatment persistence 24 months Proportion of patients discontinuing benralizumab and proportion by reason for discontinuation
Adherence to scheduled injections 24 months * Frequency of patients taking infections on schedule
* Frequency of patients taking injection within +/- 3 days injection window in an observation period
* Time between injections
Trial Locations
- Locations (8)
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
Castle Hill Hospital
🇬🇧Hull, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom