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

NCT05932849 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 276

Last updated 2023-11-28

No results posted yet for this study

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

Conditions

Interventions

DRUG

Benralizumab

Patients were initiated on benralizumab as part of routine clinical practice

Sponsors & Collaborators

Principal Investigators

  • David J Jackson, MRCP MSc PhD · Guy's & St Thomas' NHS Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05932849 on ClinicalTrials.gov