NCT05552508: BURAN

BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging

Completed Phase 4 Results posted Last updated 25 March 2025

What this trial tests

Phase 4 trial testing Benralizumab in Asthma in 45 participants. Completed in 19 July 2024.

Timeline

11 October 2022

Primary endpoint
19 July 2024

19 July 2024

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	11 October 2022
Primary completion	19 July 2024
Estimated completion	19 July 2024
Sites	25 locations across France, Belgium, United Kingdom, Australia, Portugal, United States, Spain

Drugs / interventions tested

• Benralizumab (BENRALIZUMAB) — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 70, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Untrimmed Total Mucus Volume at TLC Primary · 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.

All participants

Group	Value	95% CI
Benralizumab	-0.1279	± 0.4199

Participants with >=4 mucus plugs

Group	Value	95% CI
Benralizumab	-0.1822	± 0.4977

Participants with <4 mucus plugs

Group	Value	95% CI
Benralizumab	-0.0056	± 0.0111

OCS-dependent participants

Group	Value	95% CI
Benralizumab	-0.1619	± 0.4627

Non-OCS-dependent participants

Group	Value	95% CI
Benralizumab	-0.1260	± 0.4244

Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC Secondary · 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

Group	Value	95% CI
Benralizumab	-11.0	± 32.8

Change From Baseline in Untrimmed Total Air Trapping at FRC Secondary · Baseline and Week 13

Change from baseline in untrimmed total air trapping at FRC was assessed.

Group	Value	95% CI
Benralizumab	-0.1410	± 12.1660

Change From Baseline in Trimmed Distal Airway Wall Volume at TLC Secondary · 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.

Group	Value	95% CI
Benralizumab	-0.9386	± 6.1359

Change From Baseline in Untrimmed Distal Airway Volume at TLC Secondary · Baseline and Week 13

Change from baseline in untrimmed distal airway volume at TLC was assessed.

Group	Value	95% CI
Benralizumab	1.1225	± 4.5836

Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC) Secondary · Baseline and Week 13

Change from baseline in untrimmed distal airway volume at FRC was assessed.

Group	Value	95% CI
Benralizumab	0.5079	± 1.9741

Change From Baseline in Untrimmed Total Lung Volume at TLC Secondary · Baseline and Week 13

Change from baseline in untrimmed total lung volume at TLC was assessed.

Group	Value	95% CI
Benralizumab	0.0287	± 0.4416

Change From Baseline in Untrimmed Total Lung Volume at FRC Secondary · Baseline and Week 13

Change from baseline in untrimmed total lung volume at FRC was assessed.

Group	Value	95% CI
Benralizumab	-0.0275	± 0.5101

Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) Secondary · 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 coefficie

Group	Value	95% CI
Benralizumab	-0.2710	-0.5260 – 0.0352

Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1 Secondary · 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.

Group	Value	95% CI
Benralizumab	-0.2795	-0.5326 – 0.0260

Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FEV1 Secondary · 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.

Group	Value	95% CI
Benralizumab	-0.6892	-0.8210 – -0.4742

Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FEV1 Secondary · 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.

Group	Value	95% CI
Benralizumab	0.5380	0.2738 – 0.7205

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening (Day -21) to follow-up (up to 1.9 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Benralizumab

Serious: 2/45 (4%)

Deaths: 0/45

Serious adverse events (2 terms)

Reaction	System	Benralizumab
Respiratory tract infection	Infections and infestations	—
Asthma	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Benralizumab
Gastroenteritis	Infections and infestations	—

Most-reported serious reactions: Respiratory tract infection, Asthma.

Data from ClinicalTrials.gov NCT05552508 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biologics and airway remodeling in asthma: early, late, and potential preventive effects.
   Varricchi G, Poto R, Lommatzsch M, Brusselle G, et al · · 2025 · cited 33× · PMID 39520155 · DOI 10.1111/all.16382
2. The effects of benralizumab on airway geometry and dynamics in severe eosinophilic asthma: a single-arm study design exploring a functional respiratory imaging approach.
   Genofre E, Carstens D, DeBacker W, Muchmore P, et al · · 2023 · cited 6× · PMID 37131265 · DOI 10.1186/s12931-023-02415-4