| 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. | 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. | Posted | | Mean | Standard Deviation | Milliliters (mL) | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| | | Title | Denominators | Categories |
|---|
| All participants | | | | Participants with >=4 mucus plugs | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.0327 | | | | | | | | | | | | | | Other | | | | Participants with >=4 mucus plugs | t-test, 2 sided | | 0.0359 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| Secondary | Change From Baseline in Untrimmed Total Air Trapping at FRC | Change from baseline in untrimmed total air trapping at FRC was assessed. | 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. | Posted | | Mean | Standard Deviation | Percentage of air trapping | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| Secondary | Change From Baseline in Untrimmed Distal Airway Volume at TLC | Change from baseline in untrimmed distal airway volume at TLC was assessed. | 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. | Posted | | Mean | Standard Deviation | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Mean | Standard Deviation | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| Secondary | Change From Baseline in Untrimmed Total Lung Volume at TLC | Change from baseline in untrimmed total lung volume at TLC was assessed. | 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. | Posted | | Mean | Standard Deviation | Liters (L) | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| Secondary | Change From Baseline in Untrimmed Total Lung Volume at FRC | Change from baseline in untrimmed total lung volume at FRC was assessed. | 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. | Posted | | Mean | Standard Deviation | Liters (L) | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | Baseline endpoints analysis set included all participants who had baseline measurements and who had at least one dose of study intervention. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | At Baseline (Week 0) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | Percentage of air trapping | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | Litre | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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. | 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. | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | Percentage of air trapping | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | mL | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| 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). | 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. | Posted | | Mean | 95% Confidence Interval | Litre | | Baseline and Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| |
| Secondary | Number of Participants With Adverse Events (AEs) | The safety and tolerability of benralizumab was assessed. | The safety analysis set consisted of all participants who had received at least one dose of study intervention. | Posted | | Count of Participants | | Participants | | From screening (Day -21) to follow-up (up to 1.9 years) | | | | ID | Title | Description |
|---|
| OG000 | Benralizumab | Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8). |
| | |