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

NCT07218172 | Completed

• 1 other identifier: D3250R00126
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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).

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma related characteristics

  Number of exacerbations (baseline)

  Jan2019-Mar2024

Secondary Outcomes (1)

• Asthma related measure

  Jan2019-Mar2024

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 20, 2025
• Study Start: March 24, 2025
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

IL (1)