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

November 22, 2023 updated by: AstraZeneca

Benralizumab Patient Access Programme Study: Retrospective, Observational Study in UK Severe Asthma Centres to Describe Patient Characteristics, Treatment Patterns and Outcomes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

276

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • Hull, United Kingdom
        • Castle Hill Hospital
      • Leeds, United Kingdom
        • St James's University Hospital
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • London, United Kingdom
        • Royal Brompton Hospital
      • London, United Kingdom
        • St Bartholomew's Hospital
      • London, United Kingdom
        • Guy's Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline annual exacerbation rate
Time Frame: -12 to 0 months
Baseline frequency and annualized rate of asthma exacerbations by severity levels
-12 to 0 months
Maintenance OCS dose during baseline
Time Frame: -12 to 0 months
Maintenance OCS: frequency of patients on mOCS, dosage (for patients on mOCS), annualized cumulative dose
-12 to 0 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualised exacerbation rate (AER)
Time Frame: 12 months
AER at 12 months
12 months
Annualised exacerbation rate (AER)
Time Frame: 24 months
AER at 24 months
24 months
FEV1
Time Frame: 12 months
change in lung function from baseline
12 months
FEV1
Time Frame: 24 months
change in lung function from baseline
24 months
ACQ-6
Time Frame: 12 months
Change in asthma control (ACQ-6) score from baseline
12 months
ACQ-6
Time Frame: 24 months
Change in asthma control (ACQ-6) score from baseline
24 months
AQLQ(S)+12
Time Frame: 12 months
Change in asthma quality of life (AQLQ) from baseline
12 months
AQLQ(S)+12
Time Frame: 24 months
Change in asthma quality of life (AQLQ) from baseline
24 months
Eosinophil count
Time Frame: 12 months
Mean change in eosinophil count from baseline
12 months
Eosinophil count
Time Frame: 24 months
Mean change in eosinophil count from baseline
24 months
mOCS dose
Time Frame: 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)
12 months
mOCS dose
Time Frame: 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)
24 months
Treatment persistence
Time Frame: 24 months
Proportion of patients discontinuing benralizumab and proportion by reason for discontinuation
24 months
Adherence to scheduled injections
Time Frame: 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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3250R00090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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