CT Air-trapping for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma… (NCT03976310) | Clinical Trial Compass
CompletedNot Applicable
CT Air-trapping for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients
France59 participantsStarted 2019-06-20
Plain-language summary
BenraliScan aims to obtain thoracic computed tomography imaging data to predict the future level of patient response to a monoclonal antibody. Because the clinical responses under study can take many months to manifest, early identification of patients most-likely to benefit from treatment and treatment rule-out for others will save considerable time for everybody involved.
The primary objective of BenraliScan is to determine the prognostic value (sensitivity, specificity, positive predictive value, negative predictive value) of air-trapping measures (Expiratory/Inspiratory ratios for Mean Lung Density (MLDe/i)) detected via quantitative thoracic computed tomography at baseline for improvement in exacerbation rate (the presence of a ≥50% reduction in baseline exacerbation rate versus the absence of a ≥50% reduction in baseline exacerbation rate) at 52 weeks among eosinophilic asthma patients treated with Benralizumab.
Who can participate
Age range
18 Years – 75 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:
* Understanding and acceptance of the protocol
* The patient has given his/her informed consent and signed the consent form
* Affiliation with or beneficiary of the French national health insurance system
* Female and male patients aged 18 to 75 years (inclusively) with a history of physician-diagnosed severe asthma (according to GINA criteria) requiring treatment with high-dose inhaled corticosteroid (ICS) plus long-acting beta-agonists for at least 12 months prior to inclusion
* Documented current treatment with high daily doses of ICS (\>1000 µg equivalent beclomethasone) plus at least one other asthma controller for at least 6 months prior to inclusion
* History of at least 2 asthma exacerbations while on ICS plus another asthma controller that required treatment with systemic corticosteroids (any administration route) in the 12 months prior to inclusion. For patients receiving corticosteroids as a maintenance therapy, the corticosteroid treatment for the exacerbation is defined as a temporary increase in their maintenance dose.
* Uncontrolled disease (Asthma Control Questionnaire \>1.5)
* Pre bronchodilator forced expiratory volume at 1 second (% predicted) between 40% and 85%, established according to the NHANESIII criteria
* Blood eosinophilia ≥ 300 cells / µl at least once during the previous 12 months -OR- blood eosinophilia ≥ 300 cells / µl upon inclusion
* Women of childbearing potential must use at least one acceptable and effective form of bi…
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.
1Since this trial is completed and was studying whether a CT scan measurement called the expiratory-to-inspiratory mean lung density ratio could predict who responds well to benralizumab — has my doctor seen the results, and do they think that CT air-trapping measure might be relevant to my own situation?
2This trial focused specifically on eosinophilic asthma patients taking benralizumab — does my asthma profile match that type, and would my doctor consider benralizumab a realistic option worth discussing for me?
3The trial was measuring how well a CT scan finding predicts reduction in asthma attacks with benralizumab — is there a way my doctor could use similar CT imaging or other biomarkers to gauge whether I might be a good responder before committing to that treatment?
4Since this was a diagnostic or observational-type study rather than a treatment trial testing a new drug, what does my doctor think the findings mean practically — would they change how my doctor decides who should be offered benralizumab?
5Are there established standard treatments my doctor would want me to try first before considering biologic therapies like benralizumab, and how would the insights from a study like this one factor into that decision?
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 prognositc value (sensitivity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate
Timeframe: 52 weeks
2
The prognositc value (specificity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate