Asthma
Conditions
Keywords
BURAN, Inhaled Corticosteroids, Long-acting β2 agonists, Benralizumab, Eosinophilic Asthma
Brief 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.
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.
Interventions
COMBINATION_PRODUCTBenralizumab
Participants will receive benralizumab subcutaneously.
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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) \< 80% of predicted at V0. * 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.
Exclusion criteria
* 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. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Correlation Between Untrimmed Total Air Trapping at FRC 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. |
| Correlation Between Trimmed Distal Airway Wall Volume 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. |
| Correlation Between Untrimmed Distal Airway Volume 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. |
| Correlation Between Untrimmed Distal Airway Volume at FRC 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. |
| Correlation Between Untrimmed Total Lung Volume 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. |
| Correlation Between Untrimmed Total Lung Volume at FRC 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. |
| Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Vital Capacity (Pre-BD FVC) | 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. |
| Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FVC | 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. |
| Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FVC | 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. |
| 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. |
| Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FVC | 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. |
| Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FVC | 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. |
| Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FVC | 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. |
| Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FVC | 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. |
| Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1 | Baseline and Week 13 | 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). |
| Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1 | Baseline and Week 13 | 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. |
| Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1 | Baseline and Week 13 | 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). |
| Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1 | Baseline and Week 13 | 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). |
| Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1 | Baseline and Week 13 | 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). |
| Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1 | Baseline and Week 13 | 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). |
| Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC | Baseline and Week 13 | 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). |
| Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC | Baseline and Week 13 | 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. |
| Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC | Baseline and Week 13 | 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). |
| Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC | Baseline and Week 13 | 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). |
| Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC | Baseline and Week 13 | 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). |
| Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC | Baseline and Week 13 | 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). |
| Number of Participants With Adverse Events (AEs) | From screening (Day -21) to follow-up (up to 1.9 years) | The safety and tolerability of benralizumab was assessed. |
| Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FVC | 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. |
Countries
Australia, Belgium, France, Portugal, Spain, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted between 11 October 2022 to 19 July 2024 at 24 study centers in in Australia, Belgium, France, Portugal, Spain, United Kingdom, and United States.
Pre-assignment details
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. Informed Consent Form (ICF) was signed prior of screening procedures. All study assessments were performed as per the Schedule of Activities.
Participants by arm
| Arm | Count |
|---|---|
| Benralizumab Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
Baseline characteristics
| Characteristic | Benralizumab |
|---|---|
| Age, Continuous | 54.5 Years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 3 / 45 |
| serious Total, serious adverse events | 2 / 45 |
Outcome results
Primary
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.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume at TLC | All participants | -0.1279 Milliliters (mL) | Standard Deviation 0.4199 |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume at TLC | Participants with >=4 mucus plugs | -0.1822 Milliliters (mL) | Standard Deviation 0.4977 |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume at TLC | Participants with <4 mucus plugs | -0.0056 Milliliters (mL) | Standard Deviation 0.0111 |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume at TLC | OCS-dependent participants | -0.1619 Milliliters (mL) | Standard Deviation 0.4627 |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume at TLC | Non-OCS-dependent participants | -0.1260 Milliliters (mL) | Standard Deviation 0.4244 |
Comparison: All participantsp-value: 0.0327t-test, 2 sided
Comparison: Participants with \>=4 mucus plugsp-value: 0.0359t-test, 2 sided
Comparison: Participants with \<4 mucus plugsp-value: 0.1088t-test, 2 sided
Comparison: Non-OCS-dependent participantsp-value: 0.0391t-test, 2 sided
Secondary
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.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benralizumab | Change From Baseline in Trimmed Distal Airway Wall Volume at TLC | -0.9386 mL | Standard Deviation 6.1359 |
p-value: 0.3455t-test, 2 sided
Secondary
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).
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1 | No adjustment for pre-BD FEV1 | 5.29 mL |
| Benralizumab | Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FEV1 | Adjusted for pre-BD FEV1 | 5.61 mL |
Secondary
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).
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC | No adjustment for pre-BD FVC | 5.29 mL |
| Benralizumab | Change From Baseline in Trimmed Distal Airway Wall Volume at TLC With and Without Adjustment for Pre-BD FVC | Adjusted for pre-BD FVC | 6.08 mL |
Secondary
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.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC) | 0.5079 mL | Standard Deviation 1.9741 |
p-value: 0.9405t-test, 2 sided
Secondary
Change From Baseline in Untrimmed Distal Airway Volume at TLC
Change from baseline in untrimmed distal airway volume at TLC was assessed.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume at TLC | 1.1225 mL | Standard Deviation 4.5836 |
p-value: 0.2484t-test, 2 sided
Secondary
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).
Time frame: Baseline and Week 13
Population: 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 analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed distal airway volume at TLC: No adjustment for pre-BD FEV1 | 2.20 mL |
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed distal airway volume at TLC: Adjusted for pre-BD FEV1 | 0.61 mL |
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed distal airway volume at FRC: No adjustment for pre-BD FEV1 | -1.28 mL |
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed distal airway volume at FRC: Adjusted for pre-BD FEV1 | -1.52 mL |
Secondary
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).
Time frame: Baseline and Week 13
Population: 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 analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC | Untrimmed distal airway volume at TLC: No adjustment for pre-BD FVC | 2.20 mL |
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC | Untrimmed distal airway volume at TLC: Adjusted for pre-BD FVC | 1.22 mL |
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC | Untrimmed distal airway volume at FRC: No adjustment for pre-BD FVC | -1.28 mL |
| Benralizumab | Change From Baseline in Untrimmed Distal Airway Volume With and Without Adjustment for Pre-BD FVC | Untrimmed distal airway volume at FRC: Adjusted for pre-BD FVC | -1.28 mL |
Secondary
Change From Baseline in Untrimmed Total Air Trapping at FRC
Change from baseline in untrimmed total air trapping at FRC was assessed.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Air Trapping at FRC | -0.1410 Percentage of air trapping | Standard Deviation 12.166 |
p-value: 0.9465t-test, 2 sided
Secondary
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).
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1 | No adjustment for pre-BD FEV1 | 3.18 Percentage of air trapping |
| Benralizumab | Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FEV1 | Adjusted for pre-BD FEV1 | 5.24 Percentage of air trapping |
Secondary
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).
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC | No adjustment for pre-BD FVC | 3.18 Percentage of air trapping |
| Benralizumab | Change From Baseline in Untrimmed Total Air Trapping at FRC With and Without Adjustment for Pre-BD FVC | Adjusted for pre-BD FVC | 4.36 Percentage of air trapping |
Secondary
Change From Baseline in Untrimmed Total Lung Volume at FRC
Change from baseline in untrimmed total lung volume at FRC was assessed.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume at FRC | -0.0275 Liters (L) | Standard Deviation 0.5101 |
p-value: 0.7554t-test, 2 sided
Secondary
Change From Baseline in Untrimmed Total Lung Volume at TLC
Change from baseline in untrimmed total lung volume at TLC was assessed.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume at TLC | 0.0287 Liters (L) | Standard Deviation 0.4416 |
p-value: 0.6867t-test, 2 sided
Secondary
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).
Time frame: Baseline and Week 13
Population: 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 analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed total lung volume at TLC: No adjustment for pre-BD FEV1 | 0.11 Litre |
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed total lung volume at TLC: Adjusted for pre-BD FEV1 | 0.13 Litre |
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed total lung volume at FRC: No adjustment for pre-BD FEV1 | 0.52 Litre |
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FEV1 | Untrimmed total lung volume at FRC: Adjusted for pre-BD FEV1 | 0.37 Litre |
Secondary
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).
Time frame: Baseline and Week 13
Population: 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 analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC | Untrimmed total lung volume at TLC: No adjustment for pre-BD FVC | 0.11 Litre |
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC | Untrimmed total lung volume at TLC: Adjusted for pre-BD FVC | 0.11 Litre |
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC | Untrimmed total lung volume at FRC: No adjustment for pre-BD FVC | 0.52 Litre |
| Benralizumab | Change From Baseline in Untrimmed Total Lung Volume With and Without Adjustment for Pre-BD FVC | Untrimmed total lung volume at FRC: Adjusted for pre-BD FVC | 0.40 Litre |
Secondary
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.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC | -11.0 Scores on a scale | Standard Deviation 32.8 |
p-value: 0.0423t-test, 2 sided
Secondary
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.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1 | No adjustment for pre-BD FEV1 | 4.38 Scores on a scale |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FEV1 | Adjusted for pre-BD FEV1 | 5.97 Scores on a scale |
Secondary
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.
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC | No adjustment for pre-BD FVC | 4.38 Scores on a scale |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC With and Without Adjustment for Pre-BD FVC | Adjusted for pre-BD FVC | 4.65 Scores on a scale |
Secondary
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).
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1 | Adjusted for pre-BD FEV1 | 0.06 mL |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FEV1 | No adjustment for pre-BD FEV1 | 0.05 mL |
Secondary
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).
Time frame: Baseline and Week 13
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC | No adjustment for pre-BD FVC | 0.05 mL |
| Benralizumab | Change From Baseline in Untrimmed Total Mucus Volume Measured at TLC With and Without Adjustment for Pre-BD FVC | Adjusted for pre-BD FVC | 0.05 mL |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FEV1 | 0.5380 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Trimmed Distal Airway Wall Volume at TLC and Pre-BD FVC | 0.5476 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FEV1 | 0.4357 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Distal Airway Volume at FRC and Pre-BD FVC | 0.4706 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FEV1 | 0.6556 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Distal Airway Volume at TLC and Pre-BD FVC | 0.6110 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FEV1 | -0.6892 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Air Trapping at FRC and Pre-BD FVC | -0.3432 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FEV1 | -0.1655 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Lung Volume at FRC and Pre-BD FVC | 0.1451 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FEV1 | 0.2122 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Lung Volume at TLC and Pre-BD FVC | 0.4947 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FEV1 | -0.2795 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Mucus Plugs Score at TLC and Pre-BD FVC | -0.0273 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) | -0.2710 Correlation coefficient |
Secondary
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.
Time frame: At Baseline (Week 0)
Population: Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Benralizumab | Correlation Between Untrimmed Total Mucus Volume Measured at TLC and Pre-bronchodilator Forced Vital Capacity (Pre-BD FVC) | -0.0471 Correlation coefficient |
Secondary
Number of Participants With Adverse Events (AEs)
The safety and tolerability of benralizumab was assessed.
Time frame: From screening (Day -21) to follow-up (up to 1.9 years)
Population: The safety analysis set consisted of all participants who had received at least one dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Benralizumab | Number of Participants With Adverse Events (AEs) | Any AE | 17 Participants |
| Benralizumab | Number of Participants With Adverse Events (AEs) | Any serious adverse event (SAE) | 2 Participants |
| Benralizumab | Number of Participants With Adverse Events (AEs) | Any SAE with outcome death | 0 Participants |
| Benralizumab | Number of Participants With Adverse Events (AEs) | Any AE leading to discontinuation of study intervention | 1 Participants |
| Benralizumab | Number of Participants With Adverse Events (AEs) | Any possibly related AE | 3 Participants |