Clinical trial NCT05932849: Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres
Official title: Benralizumab Patient Access Programme Study: Retrospective, Observational Study in UK Severe Asthma Centres to Describe Patient Characteristics, Treatment Patterns and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Baseline annual exacerbation rate
timeFrame: -12 to 0 months
measure: Maintenance OCS dose during baseline
timeFrame: -12 to 0 months
Secondary outcomes:
measure: Annualised exacerbation rate (AER)
timeFrame: 12 months
measure: Annualised exacerbation rate (AER)
timeFrame: 24 months
measure: FEV1
timeFrame: 12 months
measure: FEV1
timeFrame: 24 months
measure: ACQ-6
timeFrame: 12 months
measure: ACQ-6
timeFrame: 24 months
measure: AQLQ(S)+12
timeFrame: 12 months
measure: AQLQ(S)+12
timeFrame: 24 months
measure: Eosinophil count
timeFrame: 12 months
measure: Eosinophil count
timeFrame: 24 months
measure: mOCS dose
timeFrame: 12 months
measure: mOCS dose
timeFrame: 24 months
measure: Treatment persistence
timeFrame: 24 months
measure: Adherence to scheduled injections
timeFrame: 24 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Guy's & St Thomas' NHS Trust
name: David J Jackson, MRCP MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: