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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
Secondary Objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab | Drug | Patients were initiated on benralizumab as part of routine clinical practice |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualised exacerbation rate (AER) | AER at 12 months | 12 months |
| Annualised exacerbation rate (AER) | AER at 24 months | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| David J Jackson, MRCP MSc PhD | Guy's & St Thomas' NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addenbrookes Hospital | Cambridge | United Kingdom | ||||
| Castle Hill Hospital |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
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| FEV1 | change in lung function from baseline | 12 months |
| FEV1 | change in lung function from baseline | 24 months |
| ACQ-6 | Change in asthma control (ACQ-6) score from baseline | 12 months |
| ACQ-6 | Change in asthma control (ACQ-6) score from baseline | 24 months |
| AQLQ(S)+12 | Change in asthma quality of life (AQLQ) from baseline | 12 months |
| AQLQ(S)+12 | Change in asthma quality of life (AQLQ) from baseline | 24 months |
| Eosinophil count | Mean change in eosinophil count from baseline | 12 months |
| Eosinophil count | Mean change in eosinophil count from baseline | 24 months |
| mOCS dose | 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) | 12 months |
| mOCS dose | 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) | 24 months |
| Treatment persistence | Proportion of patients discontinuing benralizumab and proportion by reason for discontinuation | 24 months |
| Adherence to scheduled injections |
| 24 months |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |