AsthmaNCT05734339
Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan (BEAT)
An observational study of Asthma, run by AstraZeneca at 6 sites in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 43 participants
- Where
- 6 sitesTaiwan
- Study dates
- 19 Jan 2023to 3 Feb 2025
- 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: 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.
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- Subject must not meet ANY exclusion criteria:
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Research Site
Changhua
Research Site
Kaohsiung City
Research Site
New Taipei City
Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan City
About this study
Official title: Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan
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
Read the detailed description
Benralizumab (Fasenra®) is a respiratory biologic agent targeting interleukin-5 (IL-5), an important member of the inflammatory cascade responsible for the pathogenesis of severe asthma. In 2019, Taiwan Food and Drug Administration (TFDA) approved benralizumab for the treatment of severe eosinophilic asthma (SEA). Since March 2020, benralizumab has been reimbursed by Taiwan National Health Insurance (NHI).
This prospective study (BEAT) aims to understand the use, effectiveness, and patient reported outcomes (PRO) of reimbursed benralizumab treatment in a real-world setting in Taiwan.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Patient Global Impression of Change (PGI-C) response and PGI-C responder endpoint (a little better, moderately better, much better)
The PGI-C is a single item designed to capture the participant's perception in change in overall disease status since the first dose of benralizumab using a 7-point scale (1- much better to 7- much worse)
Measured: 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
Patient Global Impression of Severity (PGI-S) in asthma
The PGI-S is a single question designed to capture patient's perception of overall symptom severity on a scale of no symptom to very severe
Measured: Changes from baseline after 1, 2, 3, 4, 8, 24, and 56 weeks
To determine the change on lung function after treatment with benralizumab
Pre-bronchodilator changes in FEV1 and FVC assessed by standard hospital spirometry (if available)
Measured: 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
Annualized acute exacerbation rate and changes
Measured: 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
Proportion of patients with 0, 1, and ≥ 2 acute exacerbations
Measured: at Week 24 and 56
To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
Severity of exacerbation (use or temporary increase of systemic corticosteroids, emergency department visit, or hospitalization)
Measured: at Week 24 and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Mean and median OCS daily dose reductions
Measured: at Week 4, 8, 24, and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Proportion of patients with a ≥ 25%, ≥ 50%, ≥ 75%, and 100% OCS daily dose reduction
Measured: at Week 4, 8, 24, and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Changes from baseline in cumulated OCS dose
Measured: at Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Baseline asthma disease history and commodities
Measured: known at the time of baseline data collection
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Background medication
Measured: at baseline and at Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Biomarker status (blood eosinophil and serum IgE level, if available)
Measured: at baseline and Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Adherence to benralizumab scheduled dose during study period and investigator-chosen reasons for discontinuation
Measured: through study completion, up to 56 weeks
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Most recent pre-bronchodilator FEV1 and FVC assessed by standard hospital spirometry
Measured: in the past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start19 Jan 2023
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clara Tsai, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734339
- Sponsor's protocol ID
- D3250R00109
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan
- ClinicalTrials.gov ID
- NCT05734339
- Acronym / sponsor ID
- D3250R00109
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 17 Feb 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.
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
Detailed description
Benralizumab (Fasenra®) is a respiratory biologic agent targeting interleukin-5 (IL-5), an important member of the inflammatory cascade responsible for the pathogenesis of severe asthma. In 2019, Taiwan Food and Drug Administration (TFDA) approved benralizumab for the treatment of severe eosinophilic asthma (SEA). Since March 2020, benralizumab has been reimbursed by Taiwan National Health Insurance (NHI).
This prospective study (BEAT) aims to understand the use, effectiveness, and patient reported outcomes (PRO) of reimbursed benralizumab treatment in a real-world setting in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
- Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation
Key exclusion criteria (8 listed)
- Documented active lung diseases other than asthma and not within reimbursed label
- Currently enrolled in an interventional clinical study in parallel, except:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Time frame: after 8 weeks of benralizumab treatment
Primary outcome measure: Changes from baseline in Asthma Control Questionnaire, five-question version (ACQ-5) scored from 0 (totally controlled) to 6 (severely uncontrolled)
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Time frame: after 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment
Secondary outcome measure: Changes from baseline in ACQ-5 scored from 0 (totally controlled) to 6 (severely uncontrolled)
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Time frame: at 1, 2, 3, 4, 8, 24, and 56 weeks compared to baseline
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)
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Time frame: at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment
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)
14 secondary outcomes
To assess change in overall asthma status and disease severity after initiation of benralizumab
Time frame: 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
Time frame: Changes from baseline after 1, 2, 3, 4, 8, 24, and 56 weeks
To determine the change on lung function after treatment with benralizumab
Time frame: 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
Time frame: 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
Time frame: at Week 24 and 56
To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
Time frame: at Week 24 and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Time frame: at Week 4, 8, 24, and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Time frame: at Week 4, 8, 24, and 56
To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
Time frame: at Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Time frame: known at the time of baseline data collection
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Time frame: at baseline and at Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Time frame: at baseline and Week 4, 8, 24, and 56
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Time frame: through study completion, up to 56 weeks
To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
Time frame: in the past 12 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 1 Apr 2026.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Clara Tsai study director
AstraZeneca
6 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 6 sites in Taiwan.
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 11 inclusion and 8 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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?
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting (time frame: after 8 weeks of benralizumab treatment). The study lists 4 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 1 Apr 2026.