Phase 4
N=45
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT05552508 ↗Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline in Untrimmed Total Mucus Volume at TLC — -0.1279; -0.1822; -0.0056; -0.1619 Milliliters (mL) — p=0.0327
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Benralizumab (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Untrimmed Total Mucus Volume at TLC |
-0.1279; -0.1822; -0.0056; -0.1619; -0.1260 | 0.0327 sig |
| SECONDARY Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC |
-11.0 | 0.0423 sig |
| SECONDARY Change From Baseline in Untrimmed Total Air Trapping at FRC |
-0.1410 | 0.9465 |
| SECONDARY Change From Baseline in Trimmed Distal Airway Wall Volume at TLC |
-0.9386 | 0.3455 |
| SECONDARY Change From Baseline in Untrimmed Distal Airway Volume at TLC |
1.1225 | 0.2484 |
| SECONDARY Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC) |
0.5079 | 0.9405 |
| SECONDARY Change From Baseline in Untrimmed Total Lung Volume at TLC |
0.0287 | 0.6867 |
| SECONDARY Change From Baseline in Untrimmed Total Lung Volume at FRC |
-0.0275 | 0.7554 |
| SECONDARY Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) |
-0.2710 | — |
| SECONDARY Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1 |
-0.2795 | — |
| SECONDARY Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FEV1 |
-0.6892 | — |
| SECONDARY Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FEV1 |
0.5380 | — |
| SECONDARY Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FEV1 |
0.6556 | — |
| SECONDARY Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FEV1 |
0.4357 | — |
| SECONDARY Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FEV1 |
0.2122 | — |
| SECONDARY Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FEV1 |
-0.1655 | — |
| SECONDARY Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Vital Capacity (Pre-BD FVC) |
-0.0471 | — |
| SECONDARY Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FVC |
-0.0273 | — |
| SECONDARY Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FVC |
-0.3432 | — |
| SECONDARY Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FVC |
0.5476 | — |
| SECONDARY Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FVC |
0.6110 | — |
| SECONDARY Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FVC |
0.4706 | — |
| SECONDARY Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FVC |
0.4947 | — |
| SECONDARY Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FVC |
0.1451 | — |
| SECONDARY Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1 |
0.05; 0.06 | — |
| SECONDARY Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1 |
4.38; 5.97 | — |
| SECONDARY Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1 |
3.18; 5.24 | — |
| SECONDARY Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1 |
5.29; 5.61 | — |
| SECONDARY Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1 |
2.20; 0.61; -1.28; -1.52 | — |
| SECONDARY Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1 |
0.11; 0.13; 0.52; 0.37 | — |
| SECONDARY Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC |
0.05; 0.05 | — |
| SECONDARY Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC |
4.38; 4.65 | — |
| SECONDARY Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC |
3.18; 4.36 | — |
| SECONDARY Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC |
5.29; 6.08 | — |
| SECONDARY Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC |
2.20; 1.22; -1.28; -1.28 | — |
| SECONDARY Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC |
0.11; 0.11; 0.52; 0.40 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
17; 2; 0; 1; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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) 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.
- 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).
Data sourced from ClinicalTrials.gov (NCT05552508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.