Characterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B)

Completed

• Conditions: Severe Asthma

• Registration Number: NCT07218172
• Lead Sponsor: AstraZeneca

Brief Summary

A retrospective, observational, one arm, single country study, using the computerized database of Maccabi Health Services (MHS). The study will include adult patients who initiated benralizumab treatment for SEA between January 1, 2019, and March 31, 2024. The study population will include both biologic-naive and biologic-experienced patients. Patients will be followed from 12 months before the index date until the earliest of the following dates: switching, death, leaving MHS or end of the study follow-up period (June 30, 2024).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-24
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24
• Study First Submitted: 2025-09-29
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-15
• Last Update Submitted: 2025-10-15
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

• An authorization from MHS drugs authorization center for benralizumab, with a diagnosis of asthma (ICD-9 code 493.X and the corresponding internal MHS diagnosis codes for SA). Having an authorization indicates that patients have severe eosinophilic asthma and fulfil the GINA definition of severe asthma as well as additional local reimbursement criteria.
• At least one purchase of benralizumab for the first time between January 1 2019 and March 31 2024.
• Age ≥18 years on the index date.
• MHS members for at least 12 months before the index date.

Exclusion Criteria

• Patients who received benralizumab for indication other than asthma according to MHS drugs authorization center.

- currently or recently included in a clinical trial according to the ICD-9 diagnosis code V70.7) and the corresponding internal MHS codes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma related characteristics	Jan2019-Mar2024	Number of exacerbations (baseline)

Secondary Outcome Measures

Name	Time	Method
Asthma related measure	Jan2019-Mar2024	Number of asthma exacerbations during the study period

Trial Locations

Locations (1)

Research Site; 🇮🇱 Tel Aviv, Israel