Trial · NCT05552508
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
NCT05552508, Phase 4, Completed, AstraZeneca; results first posted 2025-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging. Trials, record NCT05552508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05552508
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
- NCT number
- NCT05552508
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 45 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab
- First posted
- 2022-09-23
- Last updated
- 2025-03-25
- Other registries' IDs
- eudract:2022-000152-11
- Results first posted
- 2025-03-25
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Untrimmed Total Mucus Volume at TLC | 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. |
| Secondary | Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC | Baseline and Week 13 | 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. |
| Secondary | Change From Baseline in Untrimmed Total Air Trapping at FRC | Baseline and Week 13 | Change from baseline in untrimmed total air trapping at FRC was assessed. |
| Secondary | Change From Baseline in Trimmed Distal Airway Wall Volume at TLC | Baseline and Week 13 | 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. |
| Secondary | Change From Baseline in Untrimmed Distal Airway Volume at TLC | Baseline and Week 13 | Change from baseline in untrimmed distal airway volume at TLC was assessed. |
| Secondary | Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC) | Baseline and Week 13 | Change from baseline in untrimmed distal airway volume at FRC was assessed. |
| Secondary | Change From Baseline in Untrimmed Total Lung Volume at TLC | Baseline and Week 13 | Change from baseline in untrimmed total lung volume at TLC was assessed. |
| Secondary | Change From Baseline in Untrimmed Total Lung Volume at FRC | Baseline and Week 13 | Change from baseline in untrimmed total lung volume at FRC was assessed. |
| Secondary | Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) | At Baseline (Week 0) | 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. |
| Secondary | Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1 | At Baseline (Week 0) | 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. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Untrimmed Total Mucus Volume at TLC | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. | Milliliters (mL) | MEAN |
| SECONDARY | Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Untrimmed Total Air Trapping at FRC | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure. | Percentage of air trapping | MEAN |
| SECONDARY | Change From Baseline in Trimmed Distal Airway Wall Volume at TLC | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. | mL | MEAN |
| SECONDARY | Change From Baseline in Untrimmed Distal Airway Volume at TLC | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. | mL | MEAN |
| SECONDARY | Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC) | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure. | mL | MEAN |
| SECONDARY | Change From Baseline in Untrimmed Total Lung Volume at TLC | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. | Liters (L) | MEAN |
| SECONDARY | Change From Baseline in Untrimmed Total Lung Volume at FRC | Baseline and Week 13 | Primary analysis population set consisted portion of the evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during the study period. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure. | Liters (L) | MEAN |
| SECONDARY | Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) | At Baseline (Week 0) | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Correlation coefficient | NUMBER |
| SECONDARY | Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1 | At Baseline (Week 0) | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Correlation coefficient | NUMBER |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Untrimmed Total Mucus Volume at TLC | Benralizumab | All participants | -0.1279 | Standard Deviation 0.4199 | Milliliters (mL) |
| Change From Baseline in Untrimmed Total Mucus Volume at TLC | Benralizumab | Participants with >=4 mucus plugs | -0.1822 | Standard Deviation 0.4977 | Milliliters (mL) |
| Change From Baseline in Untrimmed Total Mucus Volume at TLC | Benralizumab | Participants with <4 mucus plugs | -0.0056 | Standard Deviation 0.0111 | Milliliters (mL) |
| Change From Baseline in Untrimmed Total Mucus Volume at TLC | Benralizumab | OCS-dependent participants | -0.1619 | Standard Deviation 0.4627 | Milliliters (mL) |
| Change From Baseline in Untrimmed Total Mucus Volume at TLC | Benralizumab | Non-OCS-dependent participants | -0.1260 | Standard Deviation 0.4244 | Milliliters (mL) |
| Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC | Benralizumab | -11.0 | Standard Deviation 32.8 | Scores on a scale | |
| Change From Baseline in Untrimmed Total Air Trapping at FRC | Benralizumab | -0.1410 | Standard Deviation 12.1660 | Percentage of air trapping | |
| Change From Baseline in Trimmed Distal Airway Wall Volume at TLC | Benralizumab | -0.9386 | Standard Deviation 6.1359 | mL | |
| Change From Baseline in Untrimmed Distal Airway Volume at TLC | Benralizumab | 1.1225 | Standard Deviation 4.5836 | mL | |
| Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC) | Benralizumab | 0.5079 | Standard Deviation 1.9741 | mL |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab | 45 | |
| Overall Study | COMPLETED | Benralizumab | 42 | |
| Overall Study | NOT COMPLETED | Benralizumab | 3 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastroenteritis | Infections and infestations | Benralizumab | 3 | 45 | 4 |
| serious | Respiratory tract infection | Infections and infestations | Benralizumab | 1 | 45 | 1 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Benralizumab | 1 | 45 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benralizumab | 0 | 45 |
| Total, other adverse events | Benralizumab | 3 | 45 |
| Total, serious adverse events | Benralizumab | 2 | 45 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05552508
GET https://conductscience.org/api/trials/v1/NCT05552508/registered?page=2