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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05552508
Registration number
NCT05552508
Ethics application status
Date submitted
27/04/2022
Date registered
23/09/2022
Titles & IDs
Public title
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
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Scientific title
BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters
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Secondary ID [1]
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0
2022-000152-11
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Secondary ID [2]
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0
D3250R00107
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Universal Trial Number (UTN)
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Trial acronym
BURAN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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0
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Condition category
Condition code
Respiratory
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0
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0
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Asthma
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Blood
0
0
0
0
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Haematological diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Benralizumab
Experimental: Benralizumab - Participants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8).
Other interventions: Benralizumab
Participants will receive benralizumab subcutaneously.
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Intervention code [1]
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0
Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in Total Mucus Volume
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Assessment method [1]
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The change from baseline to Week 13 in total mucus volume of untrimmed airways measured using quantitative CT analysis following treatment with benralizumab calculated as the mean percent change from baseline will be assessed.
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Timepoint [1]
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Baseline (at week 0), Week 13
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Secondary outcome [1]
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Change from baseline in Total mucus plugs score
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Assessment method [1]
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The change from baseline to Week 13 in airway dynamics following treatment with benralizumab as measured by mucus plugs scores will be assessed. High baseline mucus scores have shown to have significant improvements in Ventilation Defect Percent (VDP) and asthma control post-benralizumab while those with low mucus scores have not.
The scale has an upper bound of 20. An increase in Mucus Plug Score implies an increase in the number of observed obstructive mucus plugs and is understood to represent a worse outcome. A decrease represents a decrease in the number of observed obstructive mucus plugs and is understood to represent a better outcome. Mucus plugs will be scored with a scoring system based on bronchopulmonary segmental anatomy. Each bronchopulmonary segment will be given a score of 1 (mucus plug present) or 0 (mucus plug absent).
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Timepoint [1]
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Baseline (at week 0), Week 13
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Secondary outcome [2]
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Change from baseline in Total air trapping
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Assessment method [2]
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The change from baseline to Week 13 in total air trapping at functional residual capacity (FRC) measured using quantitative CT analysis following treatment with benralizumab will be assessed.
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Timepoint [2]
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Baseline (at week 0), Week 13
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Secondary outcome [3]
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Change from baseline in trimmed distal Airway wall volume (iVaww) at TLC
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Assessment method [3]
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The change from baseline to Week 13 in trimmed distal iVaww at TLC measured using quantitative CT analysis following treatment with benralizumab will be assessed.
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Timepoint [3]
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Baseline (at week 0), Week 13
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Secondary outcome [4]
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Change from baseline in distal Specific airway volume (siVaw) at TLC
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Assessment method [4]
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The change from baseline to Week 13 in trimmed distal siVaw at TLC measured using quantitative CT analysis following treatment with benralizumab will be assessed.
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Timepoint [4]
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Baseline (at week 0), Week 13
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Secondary outcome [5]
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Change from baseline in distal Specific airway volume (siVaw) at FRC
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Assessment method [5]
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The change from baseline to Week 13 in trimmed distal siVaw at FRC measured using quantitative CT analysis following treatment with benralizumab will be assessed.
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Timepoint [5]
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Baseline (at week 0), Week 13
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Secondary outcome [6]
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Change from baseline in Total Lung volume (iVlung) at TLC
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Assessment method [6]
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The change from baseline to Week 13 in total iVlung at TLC measured using quantitative CT analysis following treatment with benralizumab will be assessed.
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Timepoint [6]
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Baseline (at week 0), Week 13
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Secondary outcome [7]
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Change from baseline in Total Lung volume (iVlung) at FRC
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Assessment method [7]
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The change from baseline to Week 13 in total iVlung at FRC measured using quantitative CT analysis following treatment with benralizumab will be assessed.
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Timepoint [7]
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Baseline (at week 0), Week 13
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Secondary outcome [8]
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Correlation between imaging endpoints (Primary and Secondary FRI endpoints) and pre-bronchodilator forced expiratory volume (pre-BD FEV1)
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Assessment method [8]
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The relationship between imaging endpoints (total mucus volume at TLC, mucus plugs score at TLC, total air trapping at FRC, trimmed distal iVaww at TLC, trimmed distal siVaw at TLC and FRC, total iVlung at TLC and FRC and total mucus plugs score at TLC) and pre-BD FEV1 will be assessed.
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Timepoint [8]
0
0
Baseline (at week 0)
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Secondary outcome [9]
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Correlation between imaging endpoints (Primary and Secondary FRI endpoints) and pre-bronchodilator forced vital capacity (pre-BD FVC)
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Assessment method [9]
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The relationship between imaging endpoints (total mucus volume at TLC, total air trapping at FRC, trimmed distal iVaww at TLC, trimmed distal siVaw at TLC and FRC, total iVlung at TLC and FRC and total mucus plugs score at TLC) and pre-BD FVC will be assessed.
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Timepoint [9]
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Baseline (at week 0)
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Secondary outcome [10]
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Correlation between the change in imaging endpoints (Primary and Secondary FRI endpoints) and the change in pre-BD FEV1 (± 5 days), overall and within subgroups conditional on the baseline value of pre-BD FEV1
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Assessment method [10]
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The relationship between change from baseline to Week 13 in imaging endpoints (total mucus volume at TLC, total air trapping at FRC, trimmed distal iVaww at TLC, trimmed distal siVaw at TLC and FRC, total iVlung at TLC and FRC and total mucus plugs score at TLC) and pre-BD FEV1 will be assessed.
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Timepoint [10]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [11]
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Correlation between the change in imaging endpoints (Primary and Secondary FRI endpoints) and the change in pre-BD FVC (± 5 days), overall and within subgroups conditional on the baseline value of pre-BD FVC
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Assessment method [11]
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The relationship between change from baseline to Week 13 in imaging endpoints (total mucus volume at TLC, total air trapping at FRC, trimmed distal iVaww at TLC, trimmed distal siVaw at TLC and FRC, total iVlung at TLC and FRC and total mucus plugs score at TLC) and pre-BD FVC will be assessed.
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Timepoint [11]
0
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Baseline (at week 0), Week 13
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Secondary outcome [12]
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Number of patients with Adverse Events (AEs)
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Assessment method [12]
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The safety and tolerability of benralizumab will be assessed.
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Timepoint [12]
0
0
From screening to follow-up (up to 1.9 years)
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Secondary outcome [13]
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Change from baseline in Total Mucus Volume at TLC with and without adjustment for pre-BD FEV1
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Assessment method [13]
0
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The relationship between change from baseline to Week 13 in total mucus volume at TLC measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [13]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [14]
0
0
Change from baseline in Total Mucus Volume at TLC with and without adjustment for pre-BD FVC
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Assessment method [14]
0
0
The relationship between change from baseline to Week 13 in total mucus volume at TLC measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [14]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [15]
0
0
Change from baseline in total air trapping with and without adjustment for pre-BD FEV1
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Assessment method [15]
0
0
The relationship between change from baseline to Week 13 in total air trapping at FRC measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [15]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [16]
0
0
Change from baseline in total air trapping with and without adjustment for pre-BD FVC
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Assessment method [16]
0
0
The relationship between change from baseline to Week 13 in total air trapping at FRC measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [16]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [17]
0
0
Change from baseline in trimmed distal iVaww at TLC with and without adjustment for pre-BD FEV1
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Assessment method [17]
0
0
The relationship between change from baseline to Week 13 in trimmed distal iVaww at TLC measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [17]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [18]
0
0
Change from baseline in trimmed distal iVaww at TLC with and without adjustment for pre-BD FVC
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Assessment method [18]
0
0
The relationship between change from baseline to Week 13 in trimmed distal iVaww at TLC measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [18]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [19]
0
0
Change from baseline in trimmed distal siVaw at TLC with and without adjustment for pre-BD FEV1
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Assessment method [19]
0
0
The relationship between change from baseline to Week 13 in trimmed distal siVaw at TLC measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [19]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [20]
0
0
Change from baseline in trimmed distal siVaw at TLC with and without adjustment for pre-BD FVC
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Assessment method [20]
0
0
The relationship between change from baseline to Week 13 in trimmed distal siVaw at TLC measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [20]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [21]
0
0
Change from baseline in trimmed distal siVaw at FRC with and without adjustment for pre-BD FEV1
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Assessment method [21]
0
0
The relationship between change from baseline to Week 13 in trimmed distal siVaw at FRC measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [21]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [22]
0
0
Change from baseline in trimmed distal siVaw at FRC with and without adjustment for pre-BD FVC
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Assessment method [22]
0
0
The relationship between change from baseline to Week 13 in trimmed distal siVaw at FRC measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [22]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [23]
0
0
Change from baseline in total iVlung at TLC with and without adjustment for pre-BD FEV1
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Assessment method [23]
0
0
The relationship between change from baseline to Week 13 in total iVlung at TLC measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [23]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [24]
0
0
Change from baseline in total iVlung at TLC with and without adjustment for pre-BD FVC
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Assessment method [24]
0
0
The relationship between change from baseline to Week 13 in total iVlung at TLC measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [24]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [25]
0
0
Change from baseline in total iVlung at FRC with and without adjustment for pre-BD FEV1
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Assessment method [25]
0
0
The relationship between change from baseline to Week 13 in total iVlung at FRC measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [25]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [26]
0
0
Change from baseline in total iVlung at FRC with and without adjustment for pre-BD FVC
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Assessment method [26]
0
0
The relationship between change from baseline to Week 13 in total iVlung at FRC measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [26]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [27]
0
0
Change from baseline in total mucus plugs score with and without adjustment for pre-BD FEV1
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Assessment method [27]
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0
The relationship between change from baseline to Week 13 in total mucus plugs score measured using quantitative CT analysis and pre-BD FEV1 will be assessed.
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Timepoint [27]
0
0
Baseline (at week 0), Week 13
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Secondary outcome [28]
0
0
Change from baseline in total mucus plugs score with and without adjustment for pre-BD FVC
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Assessment method [28]
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0
The relationship between change from baseline to Week 13 in total mucus plugs score measured using quantitative CT analysis and pre-BD FVC will be assessed.
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Timepoint [28]
0
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Baseline (at week 0), Week 13
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Secondary outcome [29]
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0
Change from baseline in imaging endpoints ( Primary and Secondary FRI endpoints) for every one percent correlation between pre-BD FEV1 and pre-BD FVC
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Assessment method [29]
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The change from baseline to Week 13 in the estimated average change in each imaging endpoint (total mucus volume at TLC, total air trapping at FRC, trimmed distal iVaww at TLC, trimmed distal siVaw at TLC and FRC, total iVlung at TLC and FRC and total mucus plugs score at TLC) and pre-BD FEV1) for every one percent increase in pre-BD FEV1 and pre-BD FVC will be assessed.
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Timepoint [29]
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Week 0, and Week 13
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Eligibility
Key inclusion criteria
* Participants who are diagnosed with asthma with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0).
* Participants who have documented treatment with ICS and LABA for = 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers.
* Participants who have documented peripheral blood eosinophil count = 300 cells/µL at V0, or if Oral Corticosteroids (OCS)-dependent, a documented peripheral blood eosinophil count = 150 cells/µL at V0.
* Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V0.
* Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) = 70% at Visit 0 (V0).
* Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted at V0.
* Participants who can perform acceptable and repeatable spirometry.
* Participants who can withhold asthma maintenance medication for at least 12 hours prior to V0, 1 and 4 where spirometry and/or Computed Tomography (CT) scan procedures will be performed except for once-a-day dosage where 24 hours will be required.
* Female participants who have a negative pregnancy test prior to administration of the investigational product (IP) and high-resolution CT scan and must agree to use a highly effective method of birth control from randomization throughout the study duration and within 12 weeks after last dose of IP.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants who are unstable or who experienced an exacerbation/infection in the 6 weeks before V0.
* Participants with acute upper or lower airway infection in the 6 weeks before V0.
* Participants diagnosed with clinically important pulmonary disease other than asthma, or participants who have ever been diagnosed with pulmonary or systemic disease, other than asthma that are associated with elevated peripheral eosinophil count.
* Receipt of any biologic products for asthma within 4 months or 5 half-lives prior to V0 whichever is longer.
* History or current use of chronic (i.e., > 4 weeks) immunosuppressive medication.
* History of lung volume reduction surgery, lung resection, thermal bronchoplasty at any time before visit 0 (V0) or on active phase of pulmonary rehabilitation.
* Participants with current malignancy or history of malignancy.
* History of other clinically significant disease or abnormality.
* Participants with positive Hepatitis B, C or HIV.
* Participants with:
Positive COVID-19 test at V0, COVID-19 disease within 6 weeks before V0 or History of severe COVID-19 disease at any time, defined by the need for Intensive Care Unit stay or Mechanical Ventilation (invasive or non-invasive).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/07/2024
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
Research Site - Clayton
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Recruitment hospital [2]
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0
Research Site - Toorak Gardens
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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5065 - Toorak Gardens
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Indiana
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Kentucky
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Missouri
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Pennsylvania
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Virginia
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Country [9]
0
0
Belgium
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State/province [9]
0
0
Liege
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Namur
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Country [11]
0
0
France
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State/province [11]
0
0
Montpellier Cedex 5
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Country [12]
0
0
Portugal
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State/province [12]
0
0
Lisboa
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Country [13]
0
0
Portugal
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State/province [13]
0
0
Porto
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Country [14]
0
0
Spain
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State/province [14]
0
0
Barcelona
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Country [15]
0
0
Spain
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State/province [15]
0
0
Madrid
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Country [16]
0
0
Spain
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State/province [16]
0
0
Santander
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Country [17]
0
0
Spain
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State/province [17]
0
0
Villarreal (Castellón)
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Country [18]
0
0
United Kingdom
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State/province [18]
0
0
Bradford
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Country [19]
0
0
United Kingdom
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State/province [19]
0
0
Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.
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Trial website
https://clinicaltrials.gov/study/NCT05552508
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05552508