AsthmaPhase 4CHINOOKNCT03953300
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
A Phase 4 study testing Benralizumab in people with Asthma, run by AstraZeneca at 35 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Benralizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 8 Oct 2019to 19 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Asthma control questionnaire (ACQ-6) >1.5.
- Fewer than 12 exacerbations within the 6 months prior to Visit 3.
Who cannot join
- Any disease or concomitant medication which could affect study results or safety of study participants, including:
- current smokers
- history of cancer
- life-threatening asthma
- clinically important pulmonary disease other than asthma
- Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
Show all 13Show fewer
- Previously received:
- benralizumab
- live attenuated vaccines 30 days prior to the date of randomization.
- bronchial thermoplasty in the last 24 months prior to Visit 1
- any investigational non-biologic within 30 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
- any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
- Currently pregnant, breastfeeding or lactating women.
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States19 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Birmingham, Alabama, 35209
Research Site
Bloomfield Hills, Michigan, 48301
Research Site
Galveston, Texas, 77555
Research Site
Indianapolis, Indiana, 46268
Research Site
Iowa City, Iowa, 52242
Research Site
Jacksonville, Florida, 32204
Research Site
Kansas City, Kansas, 66160
Research Site
Lewisville, Texas, 75067
Research Site
Los Angeles, California, 90033
Research Site
Mansfield, Texas, 76063
Research Site
Maspeth, New York, 11378
Research Site
Miami, Florida, 33166
Research Site
New Bern, North Carolina, 28562
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Rochester, Minnesota, 55905
Research Site
Snellville, Georgia, 30078
Research Site
St Louis, Missouri, 63156
Research Site
Winston-Salem, North Carolina, 27104
Denmark7 sites
Research Site
Aalborg, 9000
Research Site
Aarhus N, 8200
Research Site
Copenhagen, 2400
Research Site
Hvidovre, 2650
Research Site
Næstved, 4700
Research Site
Odense C, 5000
Research Site
Vejle, 7100
United Kingdom6 sites
Research Site
Cambridge, CB2 2QQ
Research Site
Headington, OX3 9DU
Research Site
Leicester, LE3 9QP
Research Site
Liverpool, L7 8XP
Research Site
London, W1G 8HU
Research Site
Wythenshawe, M23 9LT
About this study
Official title: A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics
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.
- Conditions
- Asthma
- Being tested
- Benralizumab, Placebo
- Keywords
- Asthma, Eosinophilic Asthma, Lung Diseases, Inhaled Corticosteroids, ICS, LABA, benralizumab, Fasenra, mechanism of action, remodeling
- Medical subject headings
- Asthma, Pulmonary Eosinophilia, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabBiological
Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
PlaceboBiological
Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks Receives: Biological: Benralizumab |
| Placebo | Placebo comparator | Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Measured: From baseline to Week 48 (Visit 10)
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
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
Measured: From baseline to Week 48 (Visit 10)
Secondary outcomes (35)
The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies
The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies
Measured: From baseline to Week 48 (Visit 10)
The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Measured: From baseline to Week 48 (Visit 10)
Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans
Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans
Measured: From baseline to Week 48 (Visit 10)
Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans
Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans
Measured: From baseline to Week 48 (Visit 10)
Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT)
Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT)
Measured: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on airway epithelial cell integrity
Change in endobronchial biopsies on airway epithelial cell integrity
Measured: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on reticular basement membrane (RBM) thickening
Change in endobronchial biopsies on reticular basement membrane (RBM) thickening
Measured: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on vascularization of the sub-mucosa
Change in endobronchial biopsies on vascularization of the sub-mucosa
Measured: From baseline to Week 48 (Visit 10)
Assessments of peripheral airway resistance measured by AO
Assessments of peripheral airway resistance measured by AO
Measured: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC)
Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO)
Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume / total lung capacity (RV/TLC) ratio
Measured: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume / total lung capacity(RV/TLC) ratio
Measured: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
Measured: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume (RV)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume (RV)
Measured: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP total lung capacity (TLC)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP total lung capacity (TLC)
Measured: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP inspiratory capacity (IC)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP inspiratory capacity (IC)
Measured: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP RV/TLC ratio
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume / total lung capacity (RV/TLC) ratio
Measured: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP functional residual capacity (FRC)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP functional residual capacity (FRC)
Measured: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP vital capacity (VC)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP vital capacity (VC)
Measured: From baseline to Week 48 (Visit 10)
Change in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) as measured by spirometry
Change in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) as measured by spirometry
Measured: From baseline to Week 48 (Visit 10)
Change in post-bronchodilator (BD) forced vital capacity (FVC) as measured by spirometry
Change in post-bronchodilator (BD) forced vital capacity (FVC) as measured by spirometry
Measured: From baseline to Week 48 (Visit 10)
Change in post-bronchodilator (BD) FEV1/FVC as measured by spirometry
Change in post-bronchodilator (BD) FEV1/FVC as measured by spirometry
Measured: From baseline to Week 48 (Visit 10)
Change in basophil number (number/mm2) in endobronchial biopsies as measured by immunohistochemistry (IHC)
Change in basophil number (number/mm2) in endobronchial biopsies as measured by immunohistochemistry (IHC)
Measured: From baseline to Week 48 (Visit 10)
Absolute change from baseline to End of Treatment in mucus score assessed using computed tomography (CT) scans
Absolute change from baseline to End of Treatment in mucus score assessed using computed tomography (CT) scans
Measured: From baseline to Week 48 (Visit 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start8 Oct 2019
- Primary completion19 Oct 2026 (estimated)
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Castro, MD, Principal investigator, University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953300
- Sponsor's protocol ID
- D3250C00059
- Other IDs
- 2018-003391-13, 2018
- Acronym
- CHINOOK
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics
- ClinicalTrials.gov ID
- NCT03953300
- Acronym / sponsor ID
- CHINOOK / D3250C00059
- Conditions
- Asthma
- Keywords
- Asthma, Eosinophilic Asthma, Lung Diseases, Inhaled Corticosteroids, ICS, LABA, benralizumab, Fasenra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 19 Oct 2026 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 16 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Biological: BenralizumabAdministrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks |
| Placebo | Placebo comparator | Biological: PlaceboAdministrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| BenralizumabBenralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40. | Biological | Benralizumab |
| PlaceboMatching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40. | Biological | Placebo |
Primary outcome
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Time frame: From baseline to Week 48 (Visit 10)
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
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
Time frame: From baseline to Week 48 (Visit 10)
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
35 secondary outcomes
The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies
Time frame: From baseline to Week 48 (Visit 10)
The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans
Time frame: From baseline to Week 48 (Visit 10)
Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT)
Time frame: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on airway epithelial cell integrity
Time frame: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on reticular basement membrane (RBM) thickening
Time frame: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on vascularization of the sub-mucosa
Time frame: From baseline to Week 48 (Visit 10)
Assessments of peripheral airway resistance measured by AO
Time frame: From baseline to Week 48 (Visit 10)
Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratio
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change in post-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)
Time frame: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP residual volume (RV)
Time frame: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP total lung capacity (TLC)
Time frame: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP inspiratory capacity (IC)
Time frame: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP RV/TLC ratio
Time frame: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP functional residual capacity (FRC)
Time frame: From baseline to Week 48 (Visit 10)
Change from pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) to post-BD WBP vital capacity (VC)
Time frame: From baseline to Week 48 (Visit 10)
Change in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) as measured by spirometry
Time frame: From baseline to Week 48 (Visit 10)
Change in post-bronchodilator (BD) forced vital capacity (FVC) as measured by spirometry
Time frame: From baseline to Week 48 (Visit 10)
Change in post-bronchodilator (BD) FEV1/FVC as measured by spirometry
Time frame: From baseline to Week 48 (Visit 10)
Change in basophil number (number/mm2) in endobronchial biopsies as measured by immunohistochemistry (IHC)
Time frame: From baseline to Week 48 (Visit 10)
Absolute change from baseline to End of Treatment in mucus score assessed using computed tomography (CT) scans
Time frame: From baseline to Week 48 (Visit 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
Mario Castro, MD principal investigator
University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benralizumab in people with Asthma, run by AstraZeneca at 35 sites in 5 countries.
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 7 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Denmark, United Kingdom, Sweden, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies (time frame: From baseline to Week 48 (Visit 10)). 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?
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 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.