Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics (NCT03953300) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
United States, Canada, Denmark75 participantsStarted 2019-10-08
Plain-language summary
The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics.
Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication.
Patients who complete treatment will enter 4 weeks follow-up period.
Who can participate
Age range
18 Years – 70 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 aged 18 through 70 years.
. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.
. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2
. Negative pregnancy test.
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 trial is specifically measuring eosinophil levels in airway tissue through endobronchial biopsies — that means a scope down into the lungs — how would my doctor assess whether I'm a good candidate for that kind of procedure, and what are the risks involved?
2Since this is a Phase 4 trial of benralizumab, which means the drug is already approved, what does my doctor think about whether I should just pursue benralizumab as a standard treatment instead of enrolling in a study that involves additional procedures like CT imaging and biopsies?
3The trial is actively enrolling patients no longer — meaning no new participants are being accepted — so is there any way my doctor could help me access benralizumab or a similar biologic outside of a trial, and how would that compare to what this study was offering?
4The study is tracking changes in airway wall structure using quantitative CT scans, which means repeated radiation exposure — how many scans would typically be involved, and is that something my doctor thinks is reasonable given my overall health situation?
5Since this trial focuses on severe eosinophilic asthma specifically, how would my doctor determine whether my eosinophil levels and asthma severity actually match the profile this study was designed for, and does that affect which treatments I should be considering?
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
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Timeframe: From baseline to Week 48 (Visit 10)
2
The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging
. Fewer than 12 exacerbations within the 6 months prior to Visit 3.
Exclusion criteria
. Any disease or concomitant medication which could affect study results or safety of study participants, including:
. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
. Previously received:
. Currently pregnant, breastfeeding or lactating women.