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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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