A Non-interventional, Prospective Study With Benralizumab (NCT06422078) | Clinical Trial Compass
RecruitingNot Applicable
A Non-interventional, Prospective Study With Benralizumab
Germany300 participantsStarted 2024-07-25
Plain-language summary
This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany.
Who can participate
Age range
18 Years – 120 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:
* Male or female patients aged 18 years or older
* Confirmed diagnosis of severe eosinophilic asthma (defined according to the European Respiratory Society and American Thoracic Society and local German guidelines) treated with high-dose inhaled corticosteroids (ICS) plus long-acting beta agonists (LABA)
* Prescribed treatment with benralizumab according to label and local market reimbursement criteria
* Benralizumab treatment was not part of the study decision and treatment decision was met prior and independently of the study
* Patients must be able and willing to read and comprehend written instructions
* After full explanation, patients must have signed an informed consent form (ICF) indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study
* Patients must be willing to report asthma patient-reported outcomes (PROs) every 4 weeks and medication intake weekly
Exclusion Criteria:
* Patients who participate in an observational trial that might, in the investigators' opinion, influence the assessment for current study; or participated in a randomized clinical trial in the last 3 months
* History of anaphylaxis to any biologic therapy
* Prior treatment with any asthma biologic therapy within the last 3 months
* Concurrent asthma biologic therapy
* Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent was obtained that had not been treated with,…
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 tracks how well benralizumab controls my asthma over 52 weeks using a score called the ACT — can you explain what a meaningful improvement on that score would look like for someone with my level of asthma?
2One of the main things this study measures is whether I might be able to reduce my daily inhaled corticosteroid dose over time — is that something you think is a realistic goal for my situation, and what would need to happen before you'd consider tapering my ICS?
3Since this is a non-interventional, observational study rather than a randomised controlled trial, what does that mean for how confident we can be about the results, and does it change how you'd weigh the evidence when making decisions about my treatment?
4Benralizumab is already an approved medication, so how does participating in this observational study differ from simply being prescribed benralizumab as a standard treatment — would I be doing anything differently as a study participant?
5This trial runs for a full year with check-ins at 12, 24, and 52 weeks — given my schedule and how I'm managing my asthma right now, do you think committing to those follow-up visits is realistic, and is there a standard treatment path we should consider first?
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
Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose
Timeframe: From baseline to week 12, 24 and 52
2
Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT
Timeframe: At baseline, week 12, 24 and 52
3
Change in daily doses of prescribed inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
Timeframe: From baseline to week 12, 24 and 52
4
Change in daily doses of patient-reported inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
Timeframe: From baseline to week 12, 24 and 52
5
Reduction (in percentage) in prescribed daily ICS dose intake from baseline to week 52 after first benralizumab dose
Timeframe: From baseline to week 52
6
Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose