Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan (BEAT)

NCT05734339 | Completed

• 1 other identifier: D3250R00109
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 6

Brief Summary

An open-label, single-arm, non-interventional, prospective, multicenter study involving primary data collection within real-world settings for patients who receive benralizumab for treatment of severe uncontrolled eosinophilic asthma

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting

  Primary outcome measure: Changes from baseline in Asthma Control Questionnaire, five-question version (ACQ-5) scored from 0 (totally controlled) to 6 (severely uncontrolled)

  after 8 weeks of benralizumab treatment

• To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting

  Secondary outcome measure: Changes from baseline in ACQ-5 scored from 0 (totally controlled) to 6 (severely uncontrolled)

  after 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment

• To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting

  Secondary outcome measure: Percentage of patients with an improvement of ≥ 0.5 points (minimal clinically importance differences \[MCID\]) in ACQ-5 scored from 0 (totally controlled) to 6 (severely uncontrolled)

  at 1, 2, 3, 4, 8, 24, and 56 weeks compared to baseline

• To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting

  Percentage of patients with well-controlled asthma (ACQ-5 ≤ 0.75), partly controlled asthma (ACQ-5 between \> 0.75 and \< 1.5) and not well-controlled asthma (ACQ-5 ≥ 1.5) scored from 0 (totally controlled) to 6 (severely uncontrolled)

  at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment

Secondary Outcomes (14)

• To assess change in overall asthma status and disease severity after initiation of benralizumab

  at Week 1, 2, 3, 4, 8, 24, and 56 in asthma

• To assess change in overall asthma status and disease severity after initiation of benralizumab

  Changes from baseline after 1, 2, 3, 4, 8, 24, and 56 weeks

• To determine the change on lung function after treatment with benralizumab

  after 24 and 56 weeks of treatment with benralizumab

• To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting

  from baseline at Week 24 and 56

• To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting

  at Week 24 and 56

Other Outcomes (5)

• To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting

  at Week 8, Week 24 and 56

• To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting

  at baseline, Week 24 and 56

• To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting

  weekly from Week 1 to 4 and monthly from Week 8 to 56 during the treatment with benralizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit 57 adult patients with confirmed SEA who meet all inclusion criteria and none of the exclusion criteria. Approximately 8 hospitals will participate in the study which have experience with biologic treatment, can initiate treatment with benralizumab, and have a good oversight on the severe asthma population.

You may qualify if:

• Subjects eligible for enrolment in the study and treated with benralizumab according to Taiwan label and reimbursement criteria must meet ALL the following criteria:
• Male or female patients ≥ 18 years of age (or ≥ 20 years of age for patients enrolled before January 1st, 2023, according to age of majority as defined by Taiwan regulations), with physician's confirmed diagnosis of severe uncontrolled asthma
• Asthma requiring medium- or high-dose inhaled corticosteroid plus long-acting β-adrenoceptor agonist as maintenance treatment
• Patients who have been prescribed but not yet initiated\* treatment with reimbursed benralizumab (Fasenra®) according to the SmPC, prior to signed informed consent, and for whom the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study. \*Note: Treatment may be initiated (administration of first injection) at or after enrolment.
• Benralizumab Taiwan reimbursement criteria:
• ≥ 2 acute exacerbations in the last 12 months, including at least 1 associated with emergency department (ED) visit or hospitalization; AND
• At least 6 months of maintenance OCS use at ≥ 5 mg/day of prednisolone or equivalent dose; AND
• Peripheral blood eosinophil ≥ 300 cells/μL in the last 12 months within the year before the initiation of benralizumab.
• Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation
• Patients must be able and willing to read, comprehend written instructions, and complete the paper questionnaires required by the protocol (ACQ-5, PGI-C, and PGI-S).
• In case a patient does not own a smartphone or is not willing to perform the home spirometer, enrolment into the study is up to the physicians' discretion. We anticipate that 90% of patients will participate the home spirometer assessment.

You may not qualify if:

• Documented active lung diseases other than asthma and not within reimbursed label
• Currently enrolled in an interventional clinical study in parallel, except:
• Patients being in parallel documented in a national asthma registry
• Patients having completed any other clinical trials including those with biologic treatment.
• An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires, participate in this study, or impact the interpretations of results.
• Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥ 30 days from last dose of previous biologics.
• Patients already started benralizumab treatment are not allowed. If the patients had received benralizumab treatment before, there should be an interval of ≥ 6 months from the last dose of prior benralizumab course to the newly initiated benralizumab treatment.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Changhua, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

New Taipei City, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Research Site

Taoyuan, Taiwan

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Clara Tsai

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 17, 2023
• Study Start: January 19, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

TW (6)