Clinical trial NCT05734339: Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan (BEAT)
Official title: Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: Inclusion Criteria:

Subjects eligible for enrolment in the study and treated with benralizumab according to Taiwan label and reimbursement criteria must meet ALL the following criteria:

1. 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
2. Asthma requiring medium- or high-dose inhaled corticosteroid plus long-acting β-adrenoceptor agonist as maintenance treatment
3. 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.
4. Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation
5. 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.

Exclusion Criteria:

Subject must not meet ANY exclusion criteria:

1. Documented active lung diseases other than asthma and not within reimbursed label
2. 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.
3. 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.
4. Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥ 30 days from last dose of previous biologics.
5. 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.

Primary outcomes:
measure: To evaluate the change in asthma control after initiation of benralizumab in a real-world Taiwan setting
timeFrame: after 8 weeks of benralizumab treatment
measure: 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
measure: 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
measure: 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
Secondary outcomes:
measure: To assess change in overall asthma status and disease severity after initiation of benralizumab
timeFrame: at Week 1, 2, 3, 4, 8, 24, and 56 in asthma
measure: To assess change in overall asthma status and disease severity after initiation of benralizumab
timeFrame: Changes from baseline after 1, 2, 3, 4, 8, 24, and 56 weeks
measure: To determine the change on lung function after treatment with benralizumab
timeFrame: after 24 and 56 weeks of treatment with benralizumab
measure: To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
timeFrame: from baseline at Week 24 and 56
measure: To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
timeFrame: at Week 24 and 56
measure: To assess the rate and change of acute exacerbations after initiation of benralizumab in a real-world Taiwan setting
timeFrame: at Week 24 and 56
measure: To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
timeFrame: at Week 4, 8, 24, and 56
measure: To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
timeFrame: at Week 4, 8, 24, and 56
measure: To assess the ability to reduce OCS dose after initiation of benralizumab in a real-world Taiwan setting
timeFrame: at Week 4, 8, 24, and 56
measure: To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
timeFrame: known at the time of baseline data collection
measure: To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
timeFrame: at baseline and at Week 4, 8, 24, and 56
measure: To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
timeFrame: at baseline and Week 4, 8, 24, and 56
measure: To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
timeFrame: through study completion, up to 56 weeks
measure: To describe characteristics of patients with benralizumab treatment in a real-world Taiwan setting
timeFrame: in the past 12 months
Other outcomes:
measure: To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting
timeFrame: at Week 8, Week 24 and 56
measure: To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting
timeFrame: at baseline, Week 24 and 56
measure: To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting
timeFrame: weekly from Week 1 to 4 and monthly from Week 8 to 56 during the treatment with benralizumab
measure: To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting
timeFrame: weekly from Week 1 to 4 and monthly from Week 8 to 56 during the treatment with benralizumab
measure: To determine the clinical utility of home spirometer in severe asthma patient management in a real-world Taiwan setting
timeFrame: weekly from Week 1 to 4 and monthly from Week 8 to 56 during the treatment with benralizumab
Locations:
city: Changhua City
country: Taiwan
facility: Research Site
city: Kaohsiung City
country: Taiwan
facility: Research Site
city: New Taipei City
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Clara Tsai
role: STUDY_DIRECTOR
References: