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OpenTrials
Completed

NCT Number: NCT05932849

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Addenbrookes Hospital, Cambridge, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benralizumab

Drug

Patients were initiated on benralizumab as part of routine clinical practice

Primary outcomes

  1. Baseline annual exacerbation rate

    Time frame: -12 to 0 months

    Baseline frequency and annualized rate of asthma exacerbations by severity levels

  2. 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

Secondary outcomes

  1. Annualised exacerbation rate (AER)

    Time frame: 12 months

    AER at 12 months

  2. Annualised exacerbation rate (AER)

    Time frame: 24 months

    AER at 24 months

  3. FEV1

    Time frame: 12 months

    change in lung function from baseline

  4. FEV1

    Time frame: 24 months

    change in lung function from baseline

  5. ACQ-6

    Time frame: 12 months

    Change in asthma control (ACQ-6) score from baseline

  6. ACQ-6

    Time frame: 24 months

    Change in asthma control (ACQ-6) score from baseline

  7. AQLQ(S)+12

    Time frame: 12 months

    Change in asthma quality of life (AQLQ) from baseline

  8. AQLQ(S)+12

    Time frame: 24 months

    Change in asthma quality of life (AQLQ) from baseline

  9. Eosinophil count

    Time frame: 12 months

    Mean change in eosinophil count from baseline

  10. Eosinophil count

    Time frame: 24 months

    Mean change in eosinophil count from baseline

  11. 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. 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)

  13. Treatment persistence

    Time frame: 24 months

    Proportion of patients discontinuing benralizumab and proportion by reason for discontinuation

  14. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: BPAP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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