AsthmaBPAPNCT05932849
Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres
An observational study of Asthma, run by AstraZeneca at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Benralizumab
- How many people
- 276 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 5 Oct 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Addenbrookes Hospital
Cambridge
Castle Hill Hospital
Hull
St James's University Hospital
Leeds
Royal Liverpool University Hospital
Liverpool
Guy's Hospital
London
Royal Brompton Hospital
London
St Bartholomew's Hospital
London
Southampton General Hospital
Southampton
About this study
Official title: 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.
Read more
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
- Asthma
- Being tested
- Benralizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabDrug
Patients were initiated on benralizumab as part of routine clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline annual exacerbation rate
Baseline frequency and annualized rate of asthma exacerbations by severity levels
Measured: -12 to 0 months
Maintenance OCS dose during baseline
Maintenance OCS: frequency of patients on mOCS, dosage (for patients on mOCS), annualized cumulative dose
Measured: -12 to 0 months
Secondary outcomes (14)
Annualised exacerbation rate (AER)
AER at 12 months
Measured: 12 months
Annualised exacerbation rate (AER)
AER at 24 months
Measured: 24 months
FEV1
change in lung function from baseline
Measured: 12 months
FEV1
change in lung function from baseline
Measured: 24 months
ACQ-6
Change in asthma control (ACQ-6) score from baseline
Measured: 12 months
ACQ-6
Change in asthma control (ACQ-6) score from baseline
Measured: 24 months
AQLQ(S)+12
Change in asthma quality of life (AQLQ) from baseline
Measured: 12 months
AQLQ(S)+12
Change in asthma quality of life (AQLQ) from baseline
Measured: 24 months
Eosinophil count
Mean change in eosinophil count from baseline
Measured: 12 months
Eosinophil count
Mean change in eosinophil count from baseline
Measured: 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)
Measured: 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)
Measured: 24 months
Treatment persistence
Proportion of patients discontinuing benralizumab and proportion by reason for discontinuation
Measured: 24 months
Adherence to scheduled injections
- Frequency of patients taking infections on schedule
- Frequency of patients taking injection within +/- 3 days injection window in an observation period
- Time between injections
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start5 Oct 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Jackson, MRCP MSc PhD, Principal investigator, Guy's & St Thomas' NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932849
- Sponsor's protocol ID
- D3250R00090
- Acronym
- BPAP
- Status last verified
- Nov 2023
- First submitted
- 28 Jun 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benralizumab Patient Access Programme Study: Retrospective, Observational Study in UK Severe Asthma Centres to Describe Patient Characteristics, Treatment Patterns and Outcomes
- ClinicalTrials.gov ID
- NCT05932849
- Acronym / sponsor ID
- BPAP / D3250R00090
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabPatients were initiated on benralizumab as part of routine clinical practice | Drug | – |
Primary outcome
Baseline annual exacerbation rate
Time frame: -12 to 0 months
Baseline frequency and annualized rate of asthma exacerbations by severity levels
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
14 secondary outcomes
Annualised exacerbation rate (AER)
Time frame: 12 months
Annualised exacerbation rate (AER)
Time frame: 24 months
FEV1
Time frame: 12 months
FEV1
Time frame: 24 months
ACQ-6
Time frame: 12 months
ACQ-6
Time frame: 24 months
AQLQ(S)+12
Time frame: 12 months
AQLQ(S)+12
Time frame: 24 months
Eosinophil count
Time frame: 12 months
Eosinophil count
Time frame: 24 months
mOCS dose
Time frame: 12 months
mOCS dose
Time frame: 24 months
Treatment persistence
Time frame: 24 months
Adherence to scheduled injections
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Jackson, MRCP MSc PhD principal investigator
Guy's & St Thomas' NHS Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline annual exacerbation rate (time frame: -12 to 0 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.