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

Asthma Clinical Trial

— BPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05932849
• Other study ID #: D3250R00090
• Status: Completed
• Start date: October 5, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Benralizumab
Patients were initiated on benralizumab as part of routine clinical practice

Locations

Country	Name	City	State
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Castle Hill Hospital	Hull
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Guy's Hospital	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline annual exacerbation rate	Baseline frequency and annualized rate of asthma exacerbations by severity levels	-12 to 0 months
Primary	Maintenance OCS dose during baseline	Maintenance OCS: frequency of patients on mOCS, dosage (for patients on mOCS), annualized cumulative dose	-12 to 0 months
Secondary	Annualised exacerbation rate (AER)	AER at 12 months	12 months
Secondary	Annualised exacerbation rate (AER)	AER at 24 months	24 months
Secondary	FEV1	change in lung function from baseline	12 months
Secondary	FEV1	change in lung function from baseline	24 months
Secondary	ACQ-6	Change in asthma control (ACQ-6) score from baseline	12 months
Secondary	ACQ-6	Change in asthma control (ACQ-6) score from baseline	24 months
Secondary	AQLQ(S)+12	Change in asthma quality of life (AQLQ) from baseline	12 months
Secondary	AQLQ(S)+12	Change in asthma quality of life (AQLQ) from baseline	24 months
Secondary	Eosinophil count	Mean change in eosinophil count from baseline	12 months
Secondary	Eosinophil count	Mean change in eosinophil count from baseline	24 months
Secondary	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)	12 months
Secondary	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)	24 months
Secondary	Treatment persistence	Proportion of patients discontinuing benralizumab and proportion by reason for discontinuation	24 months
Secondary	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	24 months

External Links

•   CSR Synopsis