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    Clinical Trial Results:
    BURAN: Effects of BenralizUmab on AiRwAy DyNamics in Severe Eosinophilic Asthma using Functional Respiratory Imaging Parameters

    Summary
    EudraCT number
    2022-000152-11
    Trial protocol
    BE   ES   PT   FR  
    Global end of trial date
    19 Jul 2024

    Results information
    Results version number
    v2(current)
    This version publication date
    20 Apr 2025
    First version publication date
    20 Mar 2025
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D3250R00107
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05552508
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Sodertalje, Sodertalje, Sweden, 15185
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to describe the change from baseline in airway dynamics after 13 weeks following treatment with benralizumab, using total mucus volume measurements from untrimmed airways.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that were consistent with International Council of Harmonization (ICH)/Good Clinical Practice (GCP), applicable regulatory requirements and the AstraZeneca policy on Bioethics.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Oct 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Portugal: 5
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    45
    EEA total number of subjects
    37
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    36
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted between 11 October 2022 to 19 July 2024 at 24 study centers.

    Pre-assignment
    Screening 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Benralizumab
    Arm description
    Participants received 3 doses of benralizumab 30 milligrams (mg) as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8).
    Arm type
    Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8).

    Number of subjects in period 1
    Benralizumab
    Started
    45
    Completed
    42
    Not completed
    3
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benralizumab
    Reporting group description
    Participants received 3 doses of benralizumab 30 milligrams (mg) as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8).

    Reporting group values
    Benralizumab Total
    Number of subjects
    45 45
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    36 36
        From 65-84 years
    9 9
        85 years and over
    0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    53.4 ( 12.4 ) -
    Sex: Female, Male
    Units: Participants
        Female
    28 28
        Male
    17 17
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    6 6
        Not Hispanic or Latino
    39 39
        Unknown or Not Reported
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Benralizumab
    Reporting group description
    Participants received 3 doses of benralizumab 30 milligrams (mg) as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8).

    Primary: Change from baseline in untrimmed total mucus volume at total lung capacity (TLC)

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    End point title
    Change from baseline in untrimmed total mucus volume at total lung capacity (TLC) [1]
    End point description
    Change from baseline in airway dynamics after 13 weeks following treatment with benralizumab, using total mucus volume (specific airway volume) at 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Primary
    End point timeframe
    Baseline and Week 13
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis was not included due to tool constraint.
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        All participants (n= 39)
    -0.1279 ( 0.4199 )
        Participants with >=4 mucus plugs (n= 27)
    -0.1822 ( 0.4977 )
        Participants with <4 mucus plugs (n= 12)
    -0.0056 ( 0.0111 )
        OCS-dependent participants (n= 2)
    -0.1619 ( 0.4627 )
        Non-OCS-dependent participants (n= 37)
    -0.1260 ( 0.4244 )
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total air trapping at functional residual capacity (FRC)

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    End point title
    Change from baseline in untrimmed total air trapping at functional residual capacity (FRC)
    End point description
    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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    34
    Units: Percentage of air trapping
        arithmetic mean (standard deviation)
    -0.1410 ( 12.1660 )
    No statistical analyses for this end point

    Secondary: Change from baseline in trimmed distal airway wall volume at TLC

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    End point title
    Change from baseline in trimmed distal airway wall volume at TLC
    End point description
    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 functional respiratory imaging (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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
        arithmetic mean (standard deviation)
    -0.9386 ( 6.1359 )
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total mucus plugs score at TLC

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    End point title
    Change from baseline in untrimmed total mucus plugs score at TLC
    End point description
    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 (BS) anatomy. Mucus score was calculated by counting the number of BS which contained 1 or more mucus plug, up to a maximum score of 18 related to the 18 BS present. Here, a mucus plug is defined as complete occlusion of the airway visible at TLC. Each BS 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, where mucus score ranging from 0-18. Higher scores = worse outcome. Primary analysis population set consisted portion of evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during study period where evaluable population was defined as those who completed three doses of study intervention and had measurements of outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -11.0 ( 32.8 )
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed distal airway volume at FRC

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    End point title
    Change from baseline in untrimmed distal airway volume at FRC
    End point description
    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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    34
    Units: mL
        arithmetic mean (standard deviation)
    0.5079 ( 1.9741 )
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed distal airway volume at TLC

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    End point title
    Change from baseline in untrimmed distal airway volume at TLC
    End point description
    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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
        arithmetic mean (standard deviation)
    1.1225 ( 4.5836 )
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total air trapping at FRC and pre-BD FEV1

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    End point title
    Correlation between untrimmed total air trapping at FRC and pre-BD FEV1
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    40
    Units: Correlation coefficient
        number (confidence interval 95%)
    -0.6892 (-0.8210 to -0.4742)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total mucus plugs score at TLC and pre-BD FEV1

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    End point title
    Correlation between untrimmed total mucus plugs score at TLC and pre-BD FEV1
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    -0.2795 (-0.5326 to 0.0260)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total lung volume at FRC

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    End point title
    Change from baseline in untrimmed total lung volume at FRC
    End point description
    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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    34
    Units: Liters (L)
        arithmetic mean (standard deviation)
    -0.0275 ( 0.5101 )
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total lung volume at TLC

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    End point title
    Change from baseline in untrimmed total lung volume at TLC
    End point description
    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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: Liters (L)
        arithmetic mean (standard deviation)
    0.0287 ( 0.4416 )
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total mucus volume measured at TLC and pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1)

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    End point title
    Correlation between untrimmed total mucus volume measured at TLC and pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1)
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    -0.2710 (-0.5260 to 0.0352)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed distal airway volume at TLC and pre-BD FEV1

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    End point title
    Correlation between untrimmed distal airway volume at TLC and pre-BD FEV1
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.6556 (0.4360 to 0.7958)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed distal airway volume at FRC and pre-BD FEV1

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    End point title
    Correlation between untrimmed distal airway volume at FRC and pre-BD FEV1
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.4357 (0.1383 to 0.6548)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total lung volume at TLC and pre-BD FEV1

    Close Top of page
    End point title
    Correlation between untrimmed total lung volume at TLC and pre-BD FEV1
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.2122 (-0.0966 to 0.4799)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total lung volume at FRC and pre-BD FEV1

    Close Top of page
    End point title
    Correlation between untrimmed total lung volume at FRC and pre-BD FEV1
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    -0.1655 (-0.4519 to 0.1560)
    No statistical analyses for this end point

    Secondary: Correlation between trimmed distal airway wall volume at TLC and pre-BD FEV1

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    End point title
    Correlation between trimmed distal airway wall volume at TLC and pre-BD FEV1
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    42
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.5380 (0.2738 to 0.7205)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed distal airway volume at TLC and pre-BD FVC

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    End point title
    Correlation between untrimmed distal airway volume at TLC and pre-BD FVC
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.6110 (0.3742 to 0.7670)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total air trapping at FRC and pre-BD FVC

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    End point title
    Correlation between untrimmed total air trapping at FRC and pre-BD FVC
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    40
    Units: Correlation coefficient
        number (confidence interval 95%)
    -0.3432 (-0.5886 to -0.0311)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total mucus plugs score at TLC and pre-BD FVC

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    End point title
    Correlation between untrimmed total mucus plugs score at TLC and pre-BD FVC
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    -0.0273 (-0.3247 to 0.2756)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total mucus volume measured at TLC and pre-bronchodilator forced vital capacity (pre-BD FVC)

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    End point title
    Correlation between untrimmed total mucus volume measured at TLC and pre-bronchodilator forced vital capacity (pre-BD FVC)
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    -0.0471 (-0.3421 to 0.2574)
    No statistical analyses for this end point

    Secondary: Correlation between trimmed distal airway wall volume at TLC and pre-BD FVC

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    End point title
    Correlation between trimmed distal airway wall volume at TLC and pre-BD FVC
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    42
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.5476 (0.2863 to 0.7269)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total lung volume at TLC and pre-BD FVC

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    End point title
    Correlation between untrimmed total lung volume at TLC and pre-BD FVC
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    43
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.4947 (0.2227 to 0.6891)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed total lung volume at FRC and pre-BD FVC

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    End point title
    Correlation between untrimmed total lung volume at FRC and pre-BD FVC
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    40
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.1451 (-0.1761 to 0.4354)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total mucus volume measured at TLC with and without adjustment for pre-BD FEV1

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    End point title
    Change from baseline in untrimmed total mucus volume measured at TLC with and without adjustment for pre-BD FEV1
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FEV1 (n=39)
    0.05 (0.00 to 0.11)
        Adjusted for pre-BD FEV1 (n=39)
    0.06 (0.00 to 0.12)
    No statistical analyses for this end point

    Secondary: Correlation between untrimmed distal airway volume at FRC and pre-BD FVC

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    End point title
    Correlation between untrimmed distal airway volume at FRC and pre-BD FVC
    End point description
    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 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.
    End point type
    Secondary
    End point timeframe
    At Baseline (Week 0)
    End point values
    Benralizumab
    Number of subjects analysed
    40
    Units: Correlation coefficient
        number (confidence interval 95%)
    0.4706 (0.1806 to 0.6789)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total mucus plugs score at TLC with and without adjustment for pre-BD FEV1

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    End point title
    Change from baseline in untrimmed total mucus plugs score at TLC with and without adjustment for pre-BD FEV1
    End point description
    Relationship between change from baseline (Week 0) in airway dynamics at Week 13, with and without adjustment for pre-BD FEV1 was assessed. Mucus plugs was scored with a scoring system based on BS anatomy. Mucus score was calculated by counting number of BS which contained 1 or more mucus plug, maximum score of 18 related to 18 BS present. Here, a mucus plug is defined as complete occlusion of the airway visible at TLC. Each BS 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, where mucus score ranging from 0-18. Higher scores=worse outcome. Primary analysis population set consisted portion of evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during study period where evaluable population was defined as those who completed three doses of study intervention and had measurements of outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: Score on a scale
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FEV1 (n=39)
    4.38 (-2.87 to 11.63)
        Adjusted for pre-BD FEV1 (n=39)
    5.97 (-1.75 to 13.69)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total air trapping at FRC with and without adjustment for pre-BD FEV1

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    End point title
    Change from baseline in untrimmed total air trapping at FRC with and without adjustment for pre-BD FEV1
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    34
    Units: Percentage of air trapping
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FEV1 (n=34)
    3.18 (-3.65 to 10.01)
        Adjusted for pre-BD FEV1 (n=34)
    5.24 (-1.23 to 11.71)
    No statistical analyses for this end point

    Secondary: Change from baseline in trimmed distal airway wall volume at TLC with and without adjustment for pre-BD FEV1

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    End point title
    Change from baseline in trimmed distal airway wall volume at TLC with and without adjustment for pre-BD FEV1
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FEV1 (n=39)
    5.29 (-1.39 to 11.97)
        Adjusted for pre-BD FEV1 (n=39)
    5.61 (-1.27 to 12.48)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed distal airway volume with and without adjustment for pre-BD FEV1

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    End point title
    Change from baseline in untrimmed distal airway volume with and without adjustment for pre-BD FEV1
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
    arithmetic mean (confidence interval 95%)
        Distal airway vol. - TLC:No adjust. for pre-BDFEV1
    2.20 (-1.09 to 5.49)
        Distal airway vol. at TLC:Adjusted for pre-BD FEV1
    0.61 (-2.65 to 3.88)
        Distal airway vol.-FRC:No adjust. for pre-BDFEV1
    -1.28 (-2.82 to 0.27)
        Distal airway vol. at FRC:Adjusted for pre-BD FEV1
    -1.52 (-3.14 to 0.09)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total mucus volume measured at TLC with and without adjustment for pre-BD FVC

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    End point title
    Change from baseline in untrimmed total mucus volume measured at TLC with and without adjustment for pre-BD FVC
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FVC (n=39)
    0.05 (0.00 to 0.11)
        Adjusted for pre-BD FVC (n=39)
    0.05 (-0.01 to 0.11)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total lung volume with and without adjustment for pre-BD FEV1

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    End point title
    Change from baseline in untrimmed total lung volume with and without adjustment for pre-BD FEV1
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: Litre
    arithmetic mean (confidence interval 95%)
        Total lung vol. at TLC:No adjust. for pre-BD FEV1
    0.11 (-0.62 to 0.84)
        Total lung volume at TLC: Adjusted for pre-BD FEV1
    0.13 (-0.61 to 0.88)
        Total lung vol. at FRC:No adjust. for pre-BD FEV1
    0.52 (-0.16 to 1.21)
        Total lung volume at FRC: Adjusted for pre-BD FEV1
    0.37 (-0.25 to 0.99)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total air trapping at FRC with and without adjustment for pre-BD FVC

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    End point title
    Change from baseline in untrimmed total air trapping at FRC with and without adjustment for pre-BD FVC
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    34
    Units: Percentage of air trapping
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FVC (n=34)
    3.18 (-3.65 to 10.01)
        Adjusted for pre-BD FVC (n=34)
    4.36 (-2.06 to 10.79)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total mucus plugs score at TLC with and without adjustment for pre-BD FVC

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    End point title
    Change from baseline in untrimmed total mucus plugs score at TLC with and without adjustment for pre-BD FVC
    End point description
    Relationship between change from baseline (Week 0) in airway dynamics at Week 13, with and without adjustment for pre-BD FVC was assessed. Mucus plugs was scored with a scoring system based on BS anatomy. Mucus score was calculated by counting the number of BS which contained 1 or more mucus plug, maximum score of 18 related to 18 BS present. Here, a mucus plug is defined as complete occlusion of the airway visible at TLC. Each BS 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, where mucus score ranging from 0-18. Higher scores=worse outcome. Primary analysis population set consisted portion of evaluable population that did not have any acute asthma exacerbation nor lower respiratory tract infection during study period where evaluable population= those who completed three doses of study intervention and had measurements of outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: Score on a scale
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FVC (n=39)
    4.38 (-2.87 to 11.63)
        Adjusted for pre-BD FVC (n=39)
    4.65 (-3.00 to 12.30)
    No statistical analyses for this end point

    Secondary: Change from baseline in trimmed distal airway wall volume at TLC with and without adjustment for pre-BD FVC

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    End point title
    Change from baseline in trimmed distal airway wall volume at TLC with and without adjustment for pre-BD FVC
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
    arithmetic mean (confidence interval 95%)
        No adjustment for pre-BD FVC (n=39)
    5.29 (-1.39 to 11.97)
        Adjusted for pre-BD FVC (n=39)
    6.08 (-0.60 to 12.76)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed distal airway volume with and without adjustment for pre-BD FVC

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    End point title
    Change from baseline in untrimmed distal airway volume with and without adjustment for pre-BD FVC
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: mL
    arithmetic mean (confidence interval 95%)
        Distal airway vol. at TLC:No adjust. for pre-BDFVC
    2.20 (-1.09 to 5.49)
        Distal airway vol. at TLC: Adjusted for pre-BD FVC
    1.22 (-2.30 to 4.73)
        Distal airway vol. at FRC:No adjust. for pre-BDFVC
    -1.28 (-2.82 to 0.27)
        Distal airway vol. at FRC: Adjusted for pre-BD FVC
    -1.28 (-2.93 to 0.37)
    No statistical analyses for this end point

    Secondary: Change from baseline in untrimmed total lung volume with and without adjustment for pre-BD FVC

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    End point title
    Change from baseline in untrimmed total lung volume with and without adjustment for pre-BD FVC
    End point description
    The relationship between estimated average change from baseline (Week 0) in airway dynamics at Week 13, with and without accounting for baseline measurements of conventional lung function 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 where evaluable population was defined as those who completed the three doses of study intervention and had measurements of the outcome at both baseline and Week 13. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specified category.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 13
    End point values
    Benralizumab
    Number of subjects analysed
    39
    Units: Litre
    arithmetic mean (confidence interval 95%)
        Total lung volume at TLC:No adjust. for pre-BD FVC
    0.11 (-0.62 to 0.84)
        Total lung volume at TLC: Adjusted for pre-BD FVC
    0.11 (-0.63 to 0.85)
        Total lung volume at FRC:No adjust. for pre-BD FVC
    0.52 (-0.16 to 1.21)
        Total lung volume at FRC: Adjusted for pre-BD FVC
    0.40 (-0.22 to 1.02)
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs)

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    End point title
    Number of participants with adverse events (AEs)
    End point description
    The safety and tolerability of benralizumab was assessed. The Safety analysis set consisted of all participants who had received at least one dose of investigational product.
    End point type
    Secondary
    End point timeframe
    From screening (Day -21) to follow-up (up to 1.9 years)
    End point values
    Benralizumab
    Number of subjects analysed
    45
    Units: Participants
        Any AE
    17
        Any serious adverse event (SAE)
    2
        Any SAE with outcome death
    0
        Any AE- discontinuation of study intervention
    1
        Any possibly related AE
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening (Day -21) to follow-up (up to 1.9 years)
    Adverse event reporting additional description
    The Safety analysis set consisted of all participants who had received at least one dose of investigational product.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Benralizumab
    Reporting group description
    Participants received 3 doses of benralizumab 30 mg as subcutaneous injection once every 4 weeks (Week 0, Week 4, and Week 8).

    Serious adverse events
    Benralizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 45 (4.44%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Benralizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 45 (6.67%)
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    3 / 45 (6.67%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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