AsthmaBenraliScanNCT03976310
CT Air-trapping for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients
A study testing 48 weeks of Benralizumab and Computed tomography in people with Asthma, run by University Hospital, Montpellier at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- 48 weeks of Benralizumab and Computed tomography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jun 2019to 9 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 birth control
- Weight ≥ 40 kg
Who cannot join
- Other respiratory diseases or associated lung infections
- Patient treated with a monoclonal antibody in the 5 months preceding inclusion
- Patient who participated in a therapeutic study in the month prior to inclusion
- Patient deprived of liberty by judicial or administrative decision
- Major (adult) protected by the law (under any kind of guardianship)
- Patient in an exclusion period determined by another protocol
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- Patient who participated in another research protocol with X-ray exposure in the past 12 months
- Patient who has already participated in the present protocol
- Hypersensitivity to benralizumab or to any of the excipients: histidine, histidine hydrochloride monohydrate, trehalose dehydrate, polysorbate 20 and water for injections
- Exacerbation, antibiotics, or non-maintenance systemic steroids during the 6 weeks prior to inclusion
- Subjects with untreated helminthic parasitic infection
- Lactating or pregnant* females or females who intend to become pregnant
- Subjects with a history of anaphylaxis to any biologic therapy
- Subjects taking immunosuppressive medications (except oral prednisone and inhaled and topical corticosteroids)
- Subjects with intercurrent illnesses (eg, viral illnesses) that may compromise the safety of the subject
- Subjects who are febrile (≥ 38°C)
- Currently smoking or smoking history ≥ 20 pack years
- Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the subject is in remission and curative therapy was completed at least 12 months prior to the date of informed consent, and assent when applicable was obtained
- Subjects who have had other malignancies are eligible provided that the subject is in remission and curative therapy was completed at least 5 years prior to the date of informed consent, and assent when applicable, was obtained
Trial locations and contacts
2 sites in 1 country.
France2 sites
Assistance Publique - Hopitaux de Marseille
Marseille, 13915
University Hospitals of Montpellier
Montpellier, 34295
About this study
Official title: Computed Tomography Air-trapping Characterisation for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients
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.
Read the detailed description
Secondary, exploratory objectives include:
- To describe clinical improvement category sub-groups (e.g. non-responders versus strong responders) in terms of: target concomitant medication usage, symptomology, quality of life (questionnaires), exacerbation rates (and other adverse events) and lung function parameters, differential blood counts, serum club cell secretory protein (CCSP) levels, other quantitative thoracic computed tomography (QTCT) variables, sinus mucosal thickness.
- To perform exploratory, prognostic-value studies (including but not limited to prognostic variables derived from changes occurring over 24 weeks and from clustering or factor mining at baseline and 24 weeks). These exploratory studies will include (but are not necessarily limited to) estimating the sensitivity/specificity of baseline/early imaging variables (or combination thereof) for predicting clinical response variables.
- To describe the prognostic categories (e.g. predicted non-responder versus predicted responder) found in terms of: clinical improvement, target concomitant medication usage, symptomology, quality of life (questionnaires), exacerbation rates (and other adverse events) and lung function parameters, differential blood counts, serum CCSP levels, other QTCT variables, sinus mucosal thickness.
- To create a centralised image library associated with the study.
- To verify the reproducibility of the relationships found between mean lung density (upper and lower lung, inspiratory and expiratory), the fractal dimension of -850 HU segmentations, and clinical variables found during the SCANN'AIR study (NCT03102749).
- To explore the association between bronchial homothety curves (the homothety of two consecutive bronchial measurements as a function of bronchial generation) and disease severity/progression.
- To monitor patient safety throughout the study.
- Conditions
- Asthma
- Being tested
- 48 weeks of Benralizumab, Computed tomography
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
48 weeks of BenralizumabDrug
Benralizumab is administered for 48 weeks (week 0 to week 48) every 4 weeks for the first 3 injections (30 mg sc per injection), and then every 8 weeks for the following 5 injections.
Computed tomographyOther
Computed tomography of the thorax is performed at the beginning (week 0), middle (week 24) and towards the end (week 48) of Benralizumab therapy. A sinus scan is also added on weeks 0 and 48.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Other | The study population corresponds to severe eosinophilic asthma patients (see eligibility criteria). Receives: Drug: 48 weeks of Benralizumab; Other: Computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognositc value (sensitivity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate
The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting 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 week 52.
Measured: 52 weeks
The prognositc value (specificity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate
The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting 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 week 52.
Measured: 52 weeks
Secondary outcomes (66)
52E: the number of exacerbations occurring during follow-up
An exacerbation is defined as follows: worsening of symptoms (increased shortness of breath, cough, sputum, with or without fever) which necessitates unscheduled healthcare resource use, a need for >48h of oral corticosteroids. For oral steroids, a minimal dose of 0.25 mg/kg is required. For patients taking oral steroids on a long term basis, at least a doubling dose for 2 days is required.
Measured: 52 weeks
52cFEV1 pre BD: The change in forced expiratory volume in 1 second (FEV1) pre BD from baseline
Measured: 52 weeks
52cACQ: The change from baseline in the ACQ score
'ACQ' refers to the Asthma Control Questionnaire: The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and SABA use) omitting the FEV1 measurement from the original ACQ score. Patients are asked to recall how their asthma has been during the previous week by responding to one bronchodilator use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well controlled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Measured: 52 weeks
52CI: A clinical improvement score
52CI: A clinical improvement score starting at zero and where points are added based on the following criteria:
- 52E = 0 or 1 non-admitting† exacerbation (+1 point);
- 52cFEV1 pre BD > 300 ml in asthma patients (+1 point);
- 52cACQ > 0.5 (+1 point).
Measured: 52 weeks
Concomitant medication use
Measured: 52 weeks
The Asthma Control Questionnaire
'ACQ' refers to the Asthma Control Questionnaire: The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and SABA use) omitting the FEV1 measurement from the original ACQ score. Patients are asked to recall how their asthma has been during the previous week by responding to one bronchodilator use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well controlled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Measured: Week 0
The Asthma Control Questionnaire
'ACQ' refers to the Asthma Control Questionnaire: The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and SABA use) omitting the FEV1 measurement from the original ACQ score. Patients are asked to recall how their asthma has been during the previous week by responding to one bronchodilator use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well controlled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Measured: Week 24
The Asthma Control Questionnaire
'ACQ' refers to the Asthma Control Questionnaire: The ACQ-6 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and SABA use) omitting the FEV1 measurement from the original ACQ score. Patients are asked to recall how their asthma has been during the previous week by responding to one bronchodilator use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well controlled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Measured: Week 52
The SNOT22 Questionnaire
The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
Measured: Week 0
The SNOT22 Questionnaire
The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
Measured: Week 24
The SNOT22 Questionnaire
The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).
Measured: Week 52
The Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain questionnaire with a 2-week recall period. Each item is scored using a 7-point likert scale where scores range from 1 to 7 and higher scores indicate higher quality of life. Simple means are used to calculate the overall AQLQ score (as well as domain scores).
Measured: Week 0
The Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain questionnaire with a 2-week recall period. Each item is scored using a 7-point likert scale where scores range from 1 to 7 and higher scores indicate higher quality of life. Simple means are used to calculate the overall AQLQ score (as well as domain scores).
Measured: Week 24
The Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain questionnaire with a 2-week recall period. Each item is scored using a 7-point likert scale where scores range from 1 to 7 and higher scores indicate higher quality of life. Simple means are used to calculate the overall AQLQ score (as well as domain scores).
Measured: Week 52
Functional residual lung capacity
Measured: Week 0
Functional residual lung capacity
Measured: Week 52
Residual lung volume
Measured: Week 0
Residual lung volume
Measured: Week 52
The ratio of residual volume over total lung capacity
Measured: Week 0
The ratio of residual volume over total lung capacity
Measured: Week 52
Pre-bronchodilator forced expiratory volume in 1 second (litres)
Measured: Week 0
Pre-bronchodilator forced expiratory volume in 1 second (litres)
Measured: Week 24
Pre-bronchodilator forced expiratory volume in 1 second (litres)
Measured: Week 52
Pre-bronchodilator forced expiratory volume in 1 second (% predicted)
Measured: Week 0
Pre-bronchodilator forced expiratory volume in 1 second (% predicted)
Measured: Week 24
Pre-bronchodilator forced expiratory volume in 1 second (% predicted)
Measured: Week 52
Pre-bronchodilator forced vital capacity (litres)
Measured: Week 0
Pre-bronchodilator forced vital capacity (litres)
Measured: Week 24
Pre-bronchodilator forced vital capacity (litres)
Measured: Week 52
Pre-bronchodilator forced vital capacity (% predicted)
Measured: Week 0
Pre-bronchodilator forced vital capacity (% predicted)
Measured: Week 24
Pre-bronchodilator forced vital capacity (% predicted)
Measured: Week 52
Pre-bronchodilator forced expiratory volume in 1 second / forced vital capacity
Measured: Week 0
Pre-bronchodilator forced expiratory volume in 1 second / forced vital capacity
Measured: Week 24
Pre-bronchodilator forced expiratory volume in 1 second / forced vital capacity
Measured: Week 52
Post-bronchodilator forced expiratory volume in 1 second (litres)
Measured: Week 0
Post-bronchodilator forced expiratory volume in 1 second (litres)
Measured: Week 24
Post-bronchodilator forced expiratory volume in 1 second (litres)
Measured: Week 52
Post-bronchodilator forced expiratory volume in 1 second (% predicted)
Measured: Week 0
Post-bronchodilator forced expiratory volume in 1 second (% predicted)
Measured: Week 24
Post-bronchodilator forced expiratory volume in 1 second (% predicted)
Measured: Week 52
Complete blood count
Measured: Week 0
Complete blood count
Measured: Week 24
Complete blood count
Measured: Week 52
Club cell secretory protein (CCSP) (ng / ml)
Measured: Week 0
Club cell secretory protein (CCSP) (ng / ml)
Measured: Week 52
The ratio of expiratory to inspiratory mean lung density
Measured: Week 0
The ratio of expiratory to inspiratory mean lung density
Measured: Week 24
The ratio of expiratory to inspiratory mean lung density
Measured: Week 48
LAA-850: The % lung attenuation area at -850 hounsfield units
Measured: Week 0
LAA-850: The % lung attenuation area at -850 hounsfield units
Measured: Week 24
LAA-850: The % lung attenuation area at -850 hounsfield units
Measured: Week 48
The fractal dimension of LAA-850
Measured: Week 0
The fractal dimension of LAA-850
Measured: Week 24
The fractal dimension of LAA-850
Measured: Week 48
LAA-950: The % lung attenuation area at -950 hounsfield units
Measured: Week 0
LAA-950: The % lung attenuation area at -950 hounsfield units
Measured: Week 24
LAA-950: The % lung attenuation area at -950 hounsfield units
Measured: Week 48
The fractal dimension of LAA-950
Measured: Week 0
The fractal dimension of LAA-950
Measured: Week 24
The fractal dimension of LAA-950
Measured: Week 48
Normalized bronchial parietal thickness
From bronchial morphometry characterization on computed tomography scan
Measured: Week 0
Normalized bronchial parietal thickness
From bronchial morphometry characterization on computed tomography scan
Measured: Week 24
Normalized bronchial parietal thickness
From bronchial morphometry characterization on computed tomography scan
Measured: Week 48
Thickness of the sinus mucosa
Measured: Week 0
Thickness of the sinus mucosa
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start20 Jun 2019
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single arm protocol will study individual patient responses to 12 months of benralizumab treatment and early means of detecting them. The model is a prognostic study that will use information detected via baseline quantitative thoracic computed tomography for predicting improvement in exacerbation rate 52 weeks after the start of treatment.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Sébastien Bommart, MD PhD, Study director, University Hospitals of Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976310
- Sponsor's protocol ID
- RECHMPL18_0016
- Other IDs
- 2018-002292-18, 2018
- Acronym
- BenraliScan
- Status last verified
- Sep 2022
- First submitted
- 3 Jun 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bourdin A, Beclin MF, Chanez P, Vachier I, Pahus L, Nogue E, Skinner S, Galeazzi D, Boulhais M, Lahmar Z, Volpato M, Pissarra J, Lafaye de Micheaux P, Bommart S, Molinari N. Predicting Clinical Response to Benralizumab Using CT Imaging: Prognostic BenraliScan Study. Chest. 2026 May 7:S0012-3692(26)00613-6. doi: 10.1016/j.chest.2026.04.040. Online ahead of print.
PubMed 42106061
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Air-trapping Characterisation for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients
- ClinicalTrials.gov ID
- NCT03976310
- Acronym / sponsor ID
- BenraliScan / RECHMPL18_0016
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Secondary, exploratory objectives include:
- To describe clinical improvement category sub-groups (e.g. non-responders versus strong responders) in terms of: target concomitant medication usage, symptomology, quality of life (questionnaires), exacerbation rates (and other adverse events) and lung function parameters, differential blood counts, serum club cell secretory protein (CCSP) levels, other quantitative thoracic computed tomography (QTCT) variables, sinus mucosal thickness.
- To perform exploratory, prognostic-value studies (including but not limited to prognostic variables derived from changes occurring over 24 weeks and from clustering or factor mining at baseline and 24 weeks). These exploratory studies will include (but are not necessarily limited to) estimating the sensitivity/specificity of baseline/early imaging variables (or combination thereof) for predicting clinical response variables.
- To describe the prognostic categories (e.g. predicted non-responder versus predicted responder) found in terms of: clinical improvement, target concomitant medication usage, symptomology, quality of life (questionnaires), exacerbation rates (and other adverse events) and lung function parameters, differential blood counts, serum CCSP levels, other QTCT variables, sinus mucosal thickness.
- To create a centralised image library associated with the study.
- To verify the reproducibility of the relationships found between mean lung density (upper and lower lung, inspiratory and expiratory), the fractal dimension of -850 HU segmentations, and clinical variables found during the SCANN'AIR study (NCT03102749).
- To explore the association between bronchial homothety curves (the homothety of two consecutive bronchial measurements as a function of bronchial generation) and disease severity/progression.
- To monitor patient safety throughout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single arm protocol will study individual patient responses to 12 months of benralizumab treatment and early means of detecting them. The model is a prognostic study that will use information detected via baseline quantitative thoracic computed tomography for predicting improvement in exacerbation rate 52 weeks after the start of treatment.
| Arm | Type | Receives |
|---|---|---|
| The study population | Other | Drug: 48 weeks of Benralizumab, Other: Computed tomographyThe study population corresponds to severe eosinophilic asthma patients (see eligibility criteria). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- Other respiratory diseases or associated lung infections
- Patient treated with a monoclonal antibody in the 5 months preceding inclusion
- Patient who participated in a therapeutic study in the month prior to inclusion
- Patient deprived of liberty by judicial or administrative decision
- Major (adult) protected by the law (under any kind of guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 48 weeks of BenralizumabBenralizumab is administered for 48 weeks (week 0 to week 48) every 4 weeks for the first 3 injections (30 mg sc per injection), and then every 8 weeks for the following 5 injections. | Drug | The study population |
| Computed tomographyComputed tomography of the thorax is performed at the beginning (week 0), middle (week 24) and towards the end (week 48) of Benralizumab therapy. A sinus scan is also added on weeks 0 and 48. | Other | The study population |
Primary outcome
The prognositc value (sensitivity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate
Time frame: 52 weeks
The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting 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 week 52.
The prognositc value (specificity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate
Time frame: 52 weeks
The sensitivity and specificity of the baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting 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 week 52.
66 secondary outcomes
52E: the number of exacerbations occurring during follow-up
Time frame: 52 weeks
52cFEV1 pre BD: The change in forced expiratory volume in 1 second (FEV1) pre BD from baseline
Time frame: 52 weeks
52cACQ: The change from baseline in the ACQ score
Time frame: 52 weeks
52CI: A clinical improvement score
Time frame: 52 weeks
Concomitant medication use
Time frame: 52 weeks
The Asthma Control Questionnaire
Time frame: Week 0
The Asthma Control Questionnaire
Time frame: Week 24
The Asthma Control Questionnaire
Time frame: Week 52
The SNOT22 Questionnaire
Time frame: Week 0
The SNOT22 Questionnaire
Time frame: Week 24
The SNOT22 Questionnaire
Time frame: Week 52
The Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Week 0
The Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Week 24
The Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Week 52
Functional residual lung capacity
Time frame: Week 0
Functional residual lung capacity
Time frame: Week 52
Residual lung volume
Time frame: Week 0
Residual lung volume
Time frame: Week 52
The ratio of residual volume over total lung capacity
Time frame: Week 0
The ratio of residual volume over total lung capacity
Time frame: Week 52
Pre-bronchodilator forced expiratory volume in 1 second (litres)
Time frame: Week 0
Pre-bronchodilator forced expiratory volume in 1 second (litres)
Time frame: Week 24
Pre-bronchodilator forced expiratory volume in 1 second (litres)
Time frame: Week 52
Pre-bronchodilator forced expiratory volume in 1 second (% predicted)
Time frame: Week 0
Pre-bronchodilator forced expiratory volume in 1 second (% predicted)
Time frame: Week 24
Pre-bronchodilator forced expiratory volume in 1 second (% predicted)
Time frame: Week 52
Pre-bronchodilator forced vital capacity (litres)
Time frame: Week 0
Pre-bronchodilator forced vital capacity (litres)
Time frame: Week 24
Pre-bronchodilator forced vital capacity (litres)
Time frame: Week 52
Pre-bronchodilator forced vital capacity (% predicted)
Time frame: Week 0
Pre-bronchodilator forced vital capacity (% predicted)
Time frame: Week 24
Pre-bronchodilator forced vital capacity (% predicted)
Time frame: Week 52
Pre-bronchodilator forced expiratory volume in 1 second / forced vital capacity
Time frame: Week 0
Pre-bronchodilator forced expiratory volume in 1 second / forced vital capacity
Time frame: Week 24
Pre-bronchodilator forced expiratory volume in 1 second / forced vital capacity
Time frame: Week 52
Post-bronchodilator forced expiratory volume in 1 second (litres)
Time frame: Week 0
Post-bronchodilator forced expiratory volume in 1 second (litres)
Time frame: Week 24
Post-bronchodilator forced expiratory volume in 1 second (litres)
Time frame: Week 52
Post-bronchodilator forced expiratory volume in 1 second (% predicted)
Time frame: Week 0
Post-bronchodilator forced expiratory volume in 1 second (% predicted)
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 42106061Bourdin A, Beclin MF, Chanez P, Vachier I, Pahus L, Nogue E, Skinner S, Galeazzi D, Boulhais M, Lahmar Z, Volpato M, Pissarra J, Lafaye de Micheaux P, Bommart S, Molinari N. Predicting Clinical Response to Benralizumab Using CT Imaging: Prognostic BenraliScan Study. Chest. 2026 May 7:S0012-3692(26)00613-6. doi: 10.1016/j.chest.2026.04.040. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Bommart, MD PhD study director
University Hospitals of Montpellier, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 48 weeks of Benralizumab and Computed tomography in people with Asthma, run by University Hospital, Montpellier at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prognositc value (sensitivity) of baseline expiratory to inspiratory mean lung density (MLDe/i) for predicting improvement in exacerbation rate (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.