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Clinical Trials/NCT07218172
NCT07218172Active, not recruitingNot Applicable

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

AstraZeneca1 site in 1 country197 target enrollmentStarted: March 24, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
197
Locations
1
Primary Endpoint
Asthma related characteristics
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Outcomes

Primary Outcomes

Asthma related characteristics

Time Frame: Jan2019-Mar2024

Number of exacerbations (baseline)

Secondary Outcomes

  • Asthma related measure(Jan2019-Mar2024)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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