BPAP: Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres
Study Details
Study Description
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
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To describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients enrolled in the BPAP
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To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after benralizumab initiation
Secondary Objectives:
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To describe clinical outcomes after initiation of benralizumab therapy in severe eosinophilic asthma patients treated with benralizumab at 12 and 24 months
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To describe patients' adherence to benralizumab, persistence and discontinuation rates and reasons for discontinuation at 12 and 24 months
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- Annualised exacerbation rate (AER) [12 months]
AER at 12 months
- Annualised exacerbation rate (AER) [24 months]
AER at 24 months
- FEV1 [12 months]
change in lung function from baseline
- FEV1 [24 months]
change in lung function from baseline
- ACQ-6 [12 months]
Change in asthma control (ACQ-6) score from baseline
- ACQ-6 [24 months]
Change in asthma control (ACQ-6) score from baseline
- AQLQ(S)+12 [12 months]
Change in asthma quality of life (AQLQ) from baseline
- AQLQ(S)+12 [24 months]
Change in asthma quality of life (AQLQ) from baseline
- Eosinophil count [12 months]
Mean change in eosinophil count from baseline
- Eosinophil count [24 months]
Mean change in eosinophil count from baseline
- mOCS dose [12 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)
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients enrolled on the BPAP between April 2018 and November 2019
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Patients who have at least 1 benralizumab injection and with at least 3 months followup data from the time of enrolment into the BPAP
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Patients initiated on benralizumab outside of the BPAP by October 30, 2019.
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Where CRO employees conduct the data extraction, patients must be able and willing to give informed consent to participate in the study
Exclusion Criteria:
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Currently receiving benralizumab or any other biologic drug for the treatment of asthma in a clinical trial
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Refusal or inability to provide informed consent where the CRO will be collecting the data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Addenbrookes Hospital | Cambridge | United Kingdom | ||
| 2 | Castle Hill Hospital | Hull | United Kingdom | ||
| 3 | St James's University Hospital | Leeds | United Kingdom | ||
| 4 | Royal Liverpool University Hospital | Liverpool | United Kingdom | ||
| 5 | Guy's Hospital | London | United Kingdom | ||
| 6 | Royal Brompton Hospital | London | United Kingdom | ||
| 7 | St Bartholomew's Hospital | London | United Kingdom | ||
| 8 | Southampton General Hospital | Southampton | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: David J Jackson, MRCP MSc PhD, Guy's & St Thomas' NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D3250R00090