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

SexALL

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:
✕. 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.

What they're measuring

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

Timeframe: after 8 weeks of benralizumab treatment

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

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

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

Trial details

NCT IDNCT05734339

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-03

View on ClinicalTrials.gov More Asthma trials

Who can participate

SexALL

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:
✕. 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.

What they're measuring

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

Timeframe: after 8 weeks of benralizumab treatment

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

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

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