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NCT Number: NCT07218172

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Asthma related characteristics

    Time frame: Jan2019-Mar2024

    Number of exacerbations (baseline)

Secondary outcomes

  1. Asthma related measure

    Time frame: Jan2019-Mar2024

    Number of asthma exacerbations during the study period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: SAIL-B

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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