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Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres

NCT ID: NCT05932849

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-02-28

Brief Summary

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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

* 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

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Benralizumab

Patients were initiated on benralizumab as part of routine clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David J Jackson, MRCP MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Guy's & St Thomas' NHS Trust

Locations

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Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

Castle Hill Hospital

Hull, , United Kingdom

Site Status

St James's University Hospital

Leeds, , United Kingdom

Site Status

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Guy's Hospital

London, , United Kingdom

Site Status

Royal Brompton Hospital

London, , United Kingdom

Site Status

St Bartholomew's Hospital

London, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D3250R00090&amp;attachmentIdentifier=98d5d97e-ba89-4244-8551-245aa79edf0a&amp;fileName=BPAPII_AZ_CSR_Synopsis_V1.0_06Nov2023_Redacted.pdf&amp;versionIdentifier=

CSR Synopsis

Other Identifiers

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D3250R00090

Identifier Type: -

Identifier Source: org_study_id