Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patient… (NCT05734339) | Clinical Trial Compass
CompletedNot Applicable
Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan (BEAT)
Taiwan43 participantsStarted 2023-01-19
Plain-language 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
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. 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).
Exclusion criteria
. Documented active lung diseases other than asthma and not within reimbursed label
. Currently enrolled in an interventional clinical study in parallel, except:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Timeframe: after 8 weeks of benralizumab treatment
2
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Timeframe: after 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment
3
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Timeframe: at 1, 2, 3, 4, 8, 24, and 56 weeks compared to baseline
4
To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
Timeframe: at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab 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.