A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benr… (NCT07214753) | Clinical Trial Compass
RecruitingNot Applicable
A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
Italy335 participantsStarted 2025-12-20
Plain-language summary
This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.
Who can participate
Age range
18 Years
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:
* Adults (≥ 18 years old) diagnosed with severe uncontrolled eosinophilic asthma.
* Benralizumab has been prescribed according to the approved label and local reimbursement criteria
* Provision of signed Informed Consent Form (ICF) prior to any study-related activities
* Benralizumab has been initiated within 7 days prior to study enrollment or is planned to be initiated within 7 days after enrollment (in the latter case, provided that the decision to prescribe benralizumab is made prior to the decision to enroll the patient in the study).
Exclusion Criteria:
* Benralizumab treatment within the 12 months prior to study enrollment and up to 8 days before enrollment
* Previous participation (in the 12 months before enrollment), current participation or plan to participate within the follow up period to any other clinical trial.
* Contraindication to benralizumab as per current Summary of Product Characteristics (SmPC).
* Pregnant or lactating women.
* patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the Investigator's judgement.
* Previous or concomitant use of omalizumab, reslizumab, dupilumab, tezepelumab or mepolizumab without washout period as per clinical practice
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 specifically for severe eosinophilic asthma treated with benralizumab — how would my doctor determine whether my asthma qualifies as 'severe eosinophilic' and whether benralizumab is the right treatment for me?
2Since this is an observational study measuring whether patients reach 'clinical remission' using something called the SANI definition, can my doctor explain what that definition of remission actually means in practice and how it would be assessed in my case?
3Because this is a real-world observational study rather than a controlled trial, it's collecting data on how benralizumab performs outside of research conditions — does that mean I would just be receiving the standard treatment while being monitored, and what extra visits or data collection would be involved?
4Before considering joining this observational study, should I first discuss whether starting benralizumab treatment is the right step for my asthma management regardless of any study, so I understand my standard treatment options?
5Since this study is based in Italy and is currently recruiting, can my doctor help me understand whether my location, current medications, or overall health history would affect whether this study is even a realistic option worth exploring further?
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.
What they're measuring
1
Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition