Characterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizu… (NCT07218172) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Characterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B)
Israel197 participantsStarted 2025-03-24
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is described as characterizing severe asthma patients treated with benralizumab in Israel — does that mean it's mainly observational and collecting data rather than testing a new treatment, and how does that affect what I might get out of participating?
2Since this study is no longer actively recruiting, is there any way I could still be considered for inclusion, or should I be looking at other options for accessing benralizumab?
3Given that the primary outcome is about describing asthma-related characteristics rather than measuring whether a treatment works better, what real-world benefit might I personally see from being part of this kind of registry or observational study?
4Benralizumab is already used to treat severe asthma — how does my specific type of severe asthma, including my eosinophil levels and current medications, factor into whether this biologic might be appropriate for me outside of or alongside this study?
5Are there other active clinical trials or standard treatment pathways for severe asthma in Israel that I should be weighing alongside this study, especially since enrollment here is already closed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.