AsthmaPhase 4BURANNCT05552508
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
A Phase 4 study testing Benralizumab in people with Asthma, run by AstraZeneca at 25 sites in 7 countries.
Trial summary
This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform. 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?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 11 Oct 2022to 19 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants who are diagnosed with asthma with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0).
- Participants who have documented treatment with ICS and LABA for ≥ 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers.
- Participants who have documented peripheral blood eosinophil count ≥ 300 cells/μL at V0, or if Oral Corticosteroids (OCS)-dependent, a documented peripheral blood eosinophil count ≥ 150 cells/μL at V0.
- Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V0.
- Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ≤ 70% at Visit 0 (V0).
- Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted at V0.
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- Participants who can perform acceptable and repeatable spirometry.
- Participants who can withhold asthma maintenance medication for at least 12 hours prior to V0, 1 and 4 where spirometry and/or Computed Tomography (CT) scan procedures will be performed except for once-a-day dosage where 24 hours will be required.
- Female participants who have a negative pregnancy test prior to administration of the investigational product (IP) and high-resolution CT scan and must agree to use a highly effective method of birth control from randomization throughout the study duration and within 12 weeks after last dose of IP.
Who cannot join
- Participants who are unstable or who experienced an exacerbation/infection in the 6 weeks before V0.
- Participants with acute upper or lower airway infection in the 6 weeks before V0.
- Participants diagnosed with clinically important pulmonary disease other than asthma, or participants who have ever been diagnosed with pulmonary or systemic disease, other than asthma that are associated with elevated peripheral eosinophil count.
- Receipt of any biologic products for asthma within 4 months or 5 half-lives prior to V0 whichever is longer.
- History or current use of chronic (i.e., > 4 weeks) immunosuppressive medication.
- History of lung volume reduction surgery, lung resection, thermal bronchoplasty at any time before visit 0 (V0) or on active phase of pulmonary rehabilitation.
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- Participants with current malignancy or history of malignancy.
- History of other clinically significant disease or abnormality.
- Participants with positive Hepatitis B, C or HIV.
- Participants with:
- Positive COVID-19 test at V0, COVID-19 disease within 6 weeks before V0 or History of severe COVID-19 disease at any time, defined by the need for Intensive Care Unit stay or Mechanical Ventilation (invasive or non-invasive).
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
United States10 sites
Research Site
Charlottesville, Virginia, 22908
Research Site
DuBois, Pennsylvania, 15801
Research Site
Greenwood, Indiana, 46143
Research Site
Lexington, Kentucky, 40536
Research Site
Loxahatchee Groves, Florida, 33470
Research Site
Plantation, Florida, 33324
Research Site
St Louis, Missouri, 63110
Research Site
Tyler, Texas, 75708
Research Site
Walnut Creek, California, 94598
Research Site
Webster, Texas, 77598
Spain6 sites
Research Site
Barcelona, 08006
Research Site
Barcelona, 08017
Research Site
Barcelona, 8003
Research Site
Madrid, 28007
Research Site
Santander, 39008
Research Site
Villarreal (Castellón), 12540
Australia2 sites
Research Site
Clayton, 3168
Research Site
Toorak Gardens, 5065
United Kingdom2 sites
Research Site
Bradford, BND9 6RJ
Research Site
Nottingham, NG5 1PB
About this study
Official title: BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters
This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.
Read the detailed description
This is a phase IV, interventional single group, open-label, uncontrolled, prospective, multicenter clinical trial.
This study will be conducted in male and female participants ≥18 years old with established severe eosinophilic asthma as defined by European Respiratory Society (ERS)/American Thoracic Society (ATS) clinical guidelines inadequately controlled by treatment with Inhaled Corticosteroids-Long-acting β2 agonists (ICS-LABA) with or without oral corticosteroids (OCS) or other asthma controller medications.
Each participant will participate in the study for a minimum of 15 weeks and up to 23 weeks.
This study will comprise of:
Screening visit (V0) Visit 1 (V1; week 0; within 1 to 21 days of screening) Visit 2 (V2; week 4 ± 5 days) Visit 3 (V3; week 8 ± 5 days) Visit 4 (V4; week 13 ± 5 days) Follow-up (2 weeks [± 7 days] after V4) - Phone call follow-up. Participants will be discharged from the study after the phone call follow-up is completed.
- Conditions
- Asthma
- Being tested
- Benralizumab
- Keywords
- BURAN, Inhaled Corticosteroids, Long-acting β2 agonists, Benralizumab, Eosinophilic Asthma
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabCombination product
Also called Fasenra
Participants will receive benralizumab subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | Participants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8). Receives: Combination Product: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Untrimmed Total Mucus Volume at TLC
Change from baseline in airway dynamics after 13 weeks following treatment with benralizumab, using total mucus volume (specific airway volume) at total lung capacity (TLC) measurements from untrimmed airways was assessed.
Measured: Baseline and Week 13
Secondary outcomes (36)
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC
Change from baseline in untrimmed total mucus plugs score at TLC was assessed. Mucus plugs was scored with a scoring system similar to that by Dunican et al. with the Severe Asthma Research Program (SARP) based on bronchopulmonary segmental anatomy. The mucus score was calculated by counting the number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug[s] present) or 0 (mucus plug[s] absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores indicate worse outcome.
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC
Change from baseline in untrimmed total air trapping at FRC was assessed.
Measured: Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC
Change from baseline in trimmed distal airway wall volume at TLC was assessed. Change from baseline in airway dynamics at Week 13 following treatment with benralizumab as measured by secondary FRI endpoints, irrespective of participants characteristics was assessed.
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume at TLC
Change from baseline in untrimmed distal airway volume at TLC was assessed.
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC)
Change from baseline in untrimmed distal airway volume at FRC was assessed.
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume at TLC
Change from baseline in untrimmed total lung volume at TLC was assessed.
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume at FRC
Change from baseline in untrimmed total lung volume at FRC was assessed.
Measured: Baseline and Week 13
Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1)
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% confidence interval (CI) for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FEV1
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations. Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FEV1
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FEV1
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FEV1
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FEV1
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FEV1
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Vital Capacity (Pre-BD FVC)
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FVC
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FVC
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FVC
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FVC
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FVC
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FVC
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FVC
The relationship between airway dynamics and conventional lung function measurements, cross sectionally (at week 0) and irrespective of participants characteristics was assessed. Positive correlations were identified by values greater than 0, and negative correlations were identified by values less than 0. Statistical significance is indicated when the lower limit of the 95% CI for the correlation is greater than 0 for positive correlations or less than 0 for negative correlations.
Here, "Number" in measure type is indicating data of Spearman's rank correlation coefficient.
Measured: At Baseline (Week 0)
Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1
Relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1). Mucus plugs was scored with a scoring system similar to that by Dunican et al. with SARP based on bronchopulmonary segmental anatomy. Mucus score was calculated by counting number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores = worse outcome.
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).
Measured: Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FEV1).
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC
Relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC). Mucus plugs was scored with a scoring system similar to that by Dunican et al. with SARP based on bronchopulmonary segmental anatomy. Mucus score was calculated by counting number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores = worse outcome.
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at Week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).
Measured: Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).
Measured: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC
The relationship between changes from baseline (week 0) in airway dynamics and conventional lung function measurements at week 13, after accounting for baseline measurements of conventional lung function was assessed with and without adjustment for conventional lung function measures (pre-BD FVC).
Measured: Baseline and Week 13
Number of Participants With Adverse Events (AEs)
The safety and tolerability of benralizumab was assessed.
Measured: From screening (Day -21) to follow-up (up to 1.9 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start11 Oct 2022
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552508
- Sponsor's protocol ID
- D3250R00107
- Other IDs
- 2022-000152-11
- Acronym
- BURAN
- Status last verified
- Mar 2025
- First submitted
- 27 Apr 2022
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Carstens DD, De Backer W, Rhodes K, Muchmore P, Lavon BR, Chung SYE, Fogel R, Trudo F, Panettieri R Jr. Impact of benralizumab on airway structure/function in severe eosinophilic asthma. Respir Res. 2026 Jul 15. doi: 10.1186/s12931-026-03742-y. Online ahead of print.
PubMed 42458446Genofre E, Carstens D, DeBacker W, Muchmore P, Panettieri RA Jr, Rhodes K, Shih VH, Trudo F. The effects of benralizumab on airway geometry and dynamics in severe eosinophilic asthma: a single-arm study design exploring a functional respiratory imaging approach. Respir Res. 2023 May 3;24(1):121. doi: 10.1186/s12931-023-02415-4.
PubMed 37131265
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters
- ClinicalTrials.gov ID
- NCT05552508
- Acronym / sponsor ID
- BURAN / D3250R00107
- Conditions
- Asthma
- Keywords
- BURAN, Inhaled Corticosteroids, Long-acting β2 agonists, Benralizumab, Eosinophilic Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.
Detailed description
This is a phase IV, interventional single group, open-label, uncontrolled, prospective, multicenter clinical trial.
This study will be conducted in male and female participants ≥18 years old with established severe eosinophilic asthma as defined by European Respiratory Society (ERS)/American Thoracic Society (ATS) clinical guidelines inadequately controlled by treatment with Inhaled Corticosteroids-Long-acting β2 agonists (ICS-LABA) with or without oral corticosteroids (OCS) or other asthma controller medications.
Each participant will participate in the study for a minimum of 15 weeks and up to 23 weeks.
This study will comprise of:
Screening visit (V0) Visit 1 (V1; week 0; within 1 to 21 days of screening) Visit 2 (V2; week 4 ± 5 days) Visit 3 (V3; week 8 ± 5 days) Visit 4 (V4; week 13 ± 5 days) Follow-up (2 weeks [± 7 days] after V4) - Phone call follow-up. Participants will be discharged from the study after the phone call follow-up is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Combination Product: BenralizumabParticipants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants who are diagnosed with asthma with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0).
- Participants who have documented treatment with ICS and LABA for ≥ 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers.
- Participants who have documented peripheral blood eosinophil count ≥ 300 cells/μL at V0, or if Oral Corticosteroids (OCS)-dependent, a documented peripheral blood eosinophil count ≥ 150 cells/μL at V0.
- Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V0.
- Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ≤ 70% at Visit 0 (V0).
Key exclusion criteria (11 listed)
- Participants who are unstable or who experienced an exacerbation/infection in the 6 weeks before V0.
- Participants with acute upper or lower airway infection in the 6 weeks before V0.
- Participants diagnosed with clinically important pulmonary disease other than asthma, or participants who have ever been diagnosed with pulmonary or systemic disease, other than asthma that are associated with elevated peripheral eosinophil count.
- Receipt of any biologic products for asthma within 4 months or 5 half-lives prior to V0 whichever is longer.
- History or current use of chronic (i.e., > 4 weeks) immunosuppressive medication.
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 |
|---|---|---|
| BenralizumabAlso: FasenraParticipants will receive benralizumab subcutaneously. | Combination product | Benralizumab |
Primary outcome
Change From Baseline in Untrimmed Total Mucus Volume at TLC
Time frame: Baseline and Week 13
Change from baseline in airway dynamics after 13 weeks following treatment with benralizumab, using total mucus volume (specific airway volume) at total lung capacity (TLC) measurements from untrimmed airways was assessed.
36 secondary outcomes
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC
Time frame: Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume at TLC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC)
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume at TLC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume at FRC
Time frame: Baseline and Week 13
Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1)
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FEV1
Time frame: At Baseline (Week 0)
Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FEV1
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FEV1
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FEV1
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FEV1
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FEV1
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Vital Capacity (Pre-BD FVC)
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FVC
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FVC
Time frame: At Baseline (Week 0)
Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FVC
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FVC
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FVC
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FVC
Time frame: At Baseline (Week 0)
Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FVC
Time frame: At Baseline (Week 0)
Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1
Time frame: Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC
Time frame: Baseline and Week 13
Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC
Time frame: Baseline and Week 13
Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC
Time frame: Baseline and Week 13
Number of Participants With Adverse Events (AEs)
Time frame: From screening (Day -21) to follow-up (up to 1.9 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42458446Carstens DD, De Backer W, Rhodes K, Muchmore P, Lavon BR, Chung SYE, Fogel R, Trudo F, Panettieri R Jr. Impact of benralizumab on airway structure/function in severe eosinophilic asthma. Respir Res. 2026 Jul 15. doi: 10.1186/s12931-026-03742-y. Online ahead of print.
- Derived from this study: PubMed 37131265Genofre E, Carstens D, DeBacker W, Muchmore P, Panettieri RA Jr, Rhodes K, Shih VH, Trudo F. The effects of benralizumab on airway geometry and dynamics in severe eosinophilic asthma: a single-arm study design exploring a functional respiratory imaging approach. Respir Res. 2023 May 3;24(1):121. doi: 10.1186/s12931-023-02415-4.
- Redacted CSPLink provided by the sponsor.
- Redacted CSR synopsisLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- 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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 7 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 25 sites in 7 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 9 inclusion and 11 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Spain, Australia, Belgium, Portugal and 2 more countries. 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.
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?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Untrimmed Total Mucus Volume at TLC (time frame: Baseline and Week 13). 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 NCT05552508, which also lists 2 linked publications.
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 Mar 2025.