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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02258542
Registration number
NCT02258542
Ethics application status
Date submitted
1/09/2014
Date registered
7/10/2014
Date last updated
21/08/2019
Titles & IDs
Public title
A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
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Scientific title
A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting ß2 Agonist (BORA)
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Secondary ID [1]
0
0
U1111-1162-2422
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Secondary ID [2]
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0
D3250C00021
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Universal Trial Number (UTN)
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Trial acronym
BORA
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Benralizumab
Other interventions - Benralizumab
Experimental: Benralizumab Arm A - Benralizumab administered subcutaneously
Experimental: Benralizumab Arm B - Benralizumab administered subcutaneously
Other interventions: Benralizumab
Benralizumab administered subcutaneously
Other interventions: Benralizumab
Benralizumab administered 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 Basophils, Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [1]
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Change from baseline in hematologic lab parameter of Basophils.
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Timepoint [1]
0
0
Week 56
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Primary outcome [2]
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Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [2]
0
0
Change from baseline in hematologic lab parameter of Basophils.
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Timepoint [2]
0
0
Week 108
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Primary outcome [3]
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Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [3]
0
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Change from baseline in hematologic lab parameter of Leukocytes.
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Timepoint [3]
0
0
Week 56
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Primary outcome [4]
0
0
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [4]
0
0
Change from baseline in hematologic lab parameter of Leukocytes.
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Timepoint [4]
0
0
Week 108
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Primary outcome [5]
0
0
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [5]
0
0
Change from baseline in hematologic lab parameter of Lymphocytes.
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Timepoint [5]
0
0
Week 56
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Primary outcome [6]
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Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [6]
0
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Change from baseline in hematologic lab parameter of Lymphocytes.
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Timepoint [6]
0
0
Week 108
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Primary outcome [7]
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Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [7]
0
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Change from baseline in hematologic lab parameter of Neutrophils.
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Timepoint [7]
0
0
Week 56
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Primary outcome [8]
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Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [8]
0
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Change from baseline in hematologic lab parameter of Neutrophils.
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Timepoint [8]
0
0
Week 108
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Primary outcome [9]
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Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [9]
0
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Change from baseline in hematologic lab parameter of Eosinophils.
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Timepoint [9]
0
0
Week 56
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Primary outcome [10]
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0
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [10]
0
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Change from baseline in hematologic lab parameter of Eosinophils.
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Timepoint [10]
0
0
Week 108
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Primary outcome [11]
0
0
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [11]
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Change from baseline in chemistry tests ALT.
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Timepoint [11]
0
0
Week 56
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Primary outcome [12]
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0
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [12]
0
0
Change from baseline in hematologic lab parameter of ALT.
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Timepoint [12]
0
0
Week 108
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Primary outcome [13]
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Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [13]
0
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Change from baseline in chemistry tests AST.
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Timepoint [13]
0
0
Week 56
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Primary outcome [14]
0
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Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [14]
0
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Change from baseline in hematologic lab parameter of AST.
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Timepoint [14]
0
0
Week 108
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Primary outcome [15]
0
0
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
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Assessment method [15]
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0
Change from baseline in chemistry test Bilirubin.
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Timepoint [15]
0
0
Week 56
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Primary outcome [16]
0
0
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [16]
0
0
Change from baseline in hematologic lab parameter of Bilirubin.
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Timepoint [16]
0
0
Week 108
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Secondary outcome [1]
0
0
Number of Overall Patients With Asthma Exacerbations During Study Period
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Assessment method [1]
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Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
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Timepoint [1]
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From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
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Secondary outcome [2]
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Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [2]
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Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit
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Timepoint [2]
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0
From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
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Secondary outcome [3]
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Change From Baseline in Pre-bronchodilator FEV1 (L)
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Assessment method [3]
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Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
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Timepoint [3]
0
0
Week 56
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Secondary outcome [4]
0
0
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
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Assessment method [4]
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0
Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).
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Timepoint [4]
0
0
Week 108
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Secondary outcome [5]
0
0
Change From Baseline in Post-bronchodilator FEV1 (L)
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Assessment method [5]
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0
Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
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Timepoint [5]
0
0
Week 56
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Secondary outcome [6]
0
0
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
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Assessment method [6]
0
0
Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).
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Timepoint [6]
0
0
Week 108
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Secondary outcome [7]
0
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Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
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Assessment method [7]
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Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.
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Timepoint [7]
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Week 56
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Secondary outcome [8]
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Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [8]
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Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.
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Timepoint [8]
0
0
Week 108
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Secondary outcome [9]
0
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Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
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Assessment method [9]
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Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.
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Timepoint [9]
0
0
Week 56
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Secondary outcome [10]
0
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Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)
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Assessment method [10]
0
0
Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.
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Timepoint [10]
0
0
Week 108
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Secondary outcome [11]
0
0
Change of Blood Eosinophil Levels' Measurement in Overall Patients
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Assessment method [11]
0
0
Change from baseline to Week 56 in Blood eosinophils
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Timepoint [11]
0
0
Week 56
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Secondary outcome [12]
0
0
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
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Assessment method [12]
0
0
Change from baseline to Week 108 in Blood eosinophils.
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Timepoint [12]
0
0
Week 108
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Secondary outcome [13]
0
0
Change From Baseline in EQ-5D-5L Visual Analog Scale
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Assessment method [13]
0
0
The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.
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Timepoint [13]
0
0
Week 56
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Secondary outcome [14]
0
0
Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [14]
0
0
The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.
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Timepoint [14]
0
0
Week 108
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Secondary outcome [15]
0
0
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
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Assessment method [15]
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The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.
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Timepoint [15]
0
0
Week 68
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Secondary outcome [16]
0
0
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
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Assessment method [16]
0
0
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.
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Timepoint [16]
0
0
Week 108
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Secondary outcome [17]
0
0
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
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Assessment method [17]
0
0
The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.
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Timepoint [17]
0
0
Week 56
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Secondary outcome [18]
0
0
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
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Assessment method [18]
0
0
The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.
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Timepoint [18]
0
0
Week 108
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Secondary outcome [19]
0
0
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
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Assessment method [19]
0
0
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
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Timepoint [19]
0
0
Week 68
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Secondary outcome [20]
0
0
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
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Assessment method [20]
0
0
The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
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Timepoint [20]
0
0
Week 108
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Secondary outcome [21]
0
0
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
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Assessment method [21]
0
0
Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma
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Timepoint [21]
0
0
From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
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Secondary outcome [22]
0
0
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [22]
0
0
Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma
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Timepoint [22]
0
0
Baseline and Week 108
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Secondary outcome [23]
0
0
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
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Assessment method [23]
0
0
Endpoint: Pharmacokinetic (PK) parameters
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Timepoint [23]
0
0
Week 0 and Week 56
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Secondary outcome [24]
0
0
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [24]
0
0
Endpoint: Pharmacokinetic (PK) parameters
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Timepoint [24]
0
0
Baseline and Week 108
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Secondary outcome [25]
0
0
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
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Assessment method [25]
0
0
Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study
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Timepoint [25]
0
0
From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
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Secondary outcome [26]
0
0
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)
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Assessment method [26]
0
0
Assessments for the presence of ADA and nAb throughout study
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Timepoint [26]
0
0
From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
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Eligibility
Key inclusion criteria
Inclusion criteria
1. Informed consent (and/or assent as applicable locally) for study participation must be
obtained prior to any study related procedures being performed (local regulations are
to be followed in determining the assent/consent requirements for children and
parent(s)/guardian(s)) and according to international guidelines and/or applicable
European Union guidelines.
2. Female and male patients who completed the double-blind treatment period in a
predecessor study on benralizumab or matching placebo.
3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth
control throughout the study duration and for 16 weeks after last dose of
Investigational Product (IP).
4. For WOCBP only: Have a negative urine pregnancy test prior to administration of
Investigational Product (IP) at Visit 1.
5. All male patients who are sexually active must agree to use a double barrier method of
contraception (condom with spermicide) from the first dose of IP until 16 weeks after
their last dose.
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Minimum age
12
Years
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Maximum age
75
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
Exclusion criteria
1. Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic,
renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
haematological, psychiatric or major physical impairment that is not stable in the
opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
- Influence the findings of the studies or their interpretations
- Impede the patient's ability to complete the entire duration of study
2. A helminth parasitic infection diagnosed during a predecessor study that has either
not been treated, has been incompletely treated or has failed to respond to standard
of care therapy
3. Any clinically significant change in physical examination, vital signs,
electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a
predecessor study which in the opinion of the investigator may put the patient at risk
because of his/her participation in the study, or may influence the results of the
study, or interfere with the patient's ability to complete the entire duration of the
study
4. Current malignancy or malignancy that developed during a predecessor study (subjects
that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was
resected for cure, or in situ carcinoma of the cervix that has been treated/cured will
not be excluded).
5. Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in
this study, during the treatment period, and for 16 weeks (5 half-lives) after the
last dose of the investigational product
6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
7. Planned major surgical procedures during the conduct of the study
8. Previous participation in the present study
9. Concurrent enrolment in another clinical trial
10. AstraZeneca staff involved in the planning and/or conduct of the study
11. Employees of the study centre or any other individuals involved with the conduct of
the study or immediate family members of such individuals
12. Patients with major protocol deviations in any of the predecessor studies at the
discretion of the Sponsor
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
19/11/2014
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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
2/07/2018
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Sample size
Target
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Accrual to date
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Final
2133
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Research Site - Bedford Park
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Recruitment hospital [2]
0
0
Research Site - Box Hill
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Recruitment hospital [3]
0
0
Research Site - Clayton
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Recruitment hospital [4]
0
0
Research Site - Concord
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Recruitment hospital [5]
0
0
Research Site - Frankston
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Recruitment hospital [6]
0
0
Research Site - Nedlands
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Recruitment hospital [7]
0
0
Research Site - New Lambton Heights
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Recruitment hospital [8]
0
0
Research Site - Parkville
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Recruitment hospital [9]
0
0
Research Site - Prahran
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Recruitment hospital [10]
0
0
Research Site - Randwick
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Recruitment hospital [11]
0
0
Research Site - Woolloongabba
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Recruitment postcode(s) [1]
0
0
5042 - Bedford Park
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Recruitment postcode(s) [2]
0
0
3128 - Box Hill
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Recruitment postcode(s) [3]
0
0
3168 - Clayton
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Recruitment postcode(s) [4]
0
0
2139 - Concord
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Recruitment postcode(s) [5]
0
0
3199 - Frankston
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Recruitment postcode(s) [6]
0
0
6009 - Nedlands
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Recruitment postcode(s) [7]
0
0
2305 - New Lambton Heights
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Recruitment postcode(s) [8]
0
0
3050 - Parkville
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Recruitment postcode(s) [9]
0
0
3004 - Prahran
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Recruitment postcode(s) [10]
0
0
2031 - Randwick
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Recruitment postcode(s) [11]
0
0
4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Georgia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Iowa
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maine
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Minnesota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Mexico
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Rhode Island
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Dakota
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Utah
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Wisconsin
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Buenos Aires
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Caba
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Ciudad Autónoma de Bs. As.
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Concepción del Uruguay
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Corrientes
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Córdoba
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Florida
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Godoy Cruz
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
La Plata
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Mar del Plata
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Mendoza
Query!
Country [43]
0
0
Argentina
Query!
State/province [43]
0
0
Nueve de julio
Query!
Country [44]
0
0
Argentina
Query!
State/province [44]
0
0
Ranelagh
Query!
Country [45]
0
0
Argentina
Query!
State/province [45]
0
0
Rosario
Query!
Country [46]
0
0
Argentina
Query!
State/province [46]
0
0
San Miguel de Tucuman
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Porto Alegre
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Santo Andre
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
Sao Paulo
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
Sorocaba
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
São Paulo
Query!
Country [52]
0
0
Bulgaria
Query!
State/province [52]
0
0
Dupnitsa
Query!
Country [53]
0
0
Bulgaria
Query!
State/province [53]
0
0
Pazardzhik
Query!
Country [54]
0
0
Bulgaria
Query!
State/province [54]
0
0
Pernik
Query!
Country [55]
0
0
Bulgaria
Query!
State/province [55]
0
0
Petrich
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Pleven
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Ruse
Query!
Country [58]
0
0
Bulgaria
Query!
State/province [58]
0
0
Samokov
Query!
Country [59]
0
0
Bulgaria
Query!
State/province [59]
0
0
Sliven
Query!
Country [60]
0
0
Bulgaria
Query!
State/province [60]
0
0
Sofia
Query!
Country [61]
0
0
Bulgaria
Query!
State/province [61]
0
0
Stara Zagora
Query!
Country [62]
0
0
Bulgaria
Query!
State/province [62]
0
0
Varna
Query!
Country [63]
0
0
Bulgaria
Query!
State/province [63]
0
0
Velingrad
Query!
Country [64]
0
0
Bulgaria
Query!
State/province [64]
0
0
Vratsa
Query!
Country [65]
0
0
Bulgaria
Query!
State/province [65]
0
0
Yambol
Query!
Country [66]
0
0
Canada
Query!
State/province [66]
0
0
Alberta
Query!
Country [67]
0
0
Canada
Query!
State/province [67]
0
0
British Columbia
Query!
Country [68]
0
0
Canada
Query!
State/province [68]
0
0
Ontario
Query!
Country [69]
0
0
Canada
Query!
State/province [69]
0
0
Quebec
Query!
Country [70]
0
0
Chile
Query!
State/province [70]
0
0
Quillota
Query!
Country [71]
0
0
Chile
Query!
State/province [71]
0
0
Santiago
Query!
Country [72]
0
0
Chile
Query!
State/province [72]
0
0
Talcahuano
Query!
Country [73]
0
0
Chile
Query!
State/province [73]
0
0
Valparaiso
Query!
Country [74]
0
0
Chile
Query!
State/province [74]
0
0
Viña del Mar
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Jindrichuv Hradec
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Karlovy Vary
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Ostrava
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Plzen
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Praha
Query!
Country [80]
0
0
Czechia
Query!
State/province [80]
0
0
Rokycany
Query!
Country [81]
0
0
Czechia
Query!
State/province [81]
0
0
Strakonice
Query!
Country [82]
0
0
Czechia
Query!
State/province [82]
0
0
Teplice
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Brest Cedex
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Dijon Cedex
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Le Kremlin Bicêtre
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Le Mans Cedex
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Lyon Cedex 4
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Marseille
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Montpellier
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Paris
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Pau Cedex
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Pringy Cedex
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Saint Pierre
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Strasbourg Cedex
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Toulouse CEDEX 09
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Aschaffenburg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Bamberg
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Berlin
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Bonn
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Frankfurt am Main
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Frankfurt/Main
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Frankfurt
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Geesthacht
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Grosshansdorf
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Hamburg
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Hannover
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Herford
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Leipzig
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Mainz Am Rhein
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
München
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Neu-Isenburg
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Rostock
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Rüdersdorf
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Witten
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Asahi-shi
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Chiyoda-ku
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Chuo-ku
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Fukuoka-shi
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Hiroshima-shi
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Itabashi-ku
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Kagoshima-shi
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Kishiwada-shi
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Kobe-shi
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Kokubunji-shi
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Matsue-shi
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Minato-ku
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Mizunami-shi
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Niigata-shi
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Obihiro-shi
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Oita-shi
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Ota-shi
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Sagamihara-shi
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Sakai-shi
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Sakaide-shi
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Sapporo-shi
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Sendai-shi
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Setagaya-ku
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Shibuya-ku
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Shinagawa-ku
Query!
Country [140]
0
0
Japan
Query!
State/province [140]
0
0
Sumida-ku
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Takamatsu-shi
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Toshima-ku
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Tsukubo-gun
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Yokohama-shi
Query!
Country [145]
0
0
Korea, Republic of
Query!
State/province [145]
0
0
Anyang-si
Query!
Country [146]
0
0
Korea, Republic of
Query!
State/province [146]
0
0
Bucheon-si
Query!
Country [147]
0
0
Korea, Republic of
Query!
State/province [147]
0
0
Busan
Query!
Country [148]
0
0
Korea, Republic of
Query!
State/province [148]
0
0
Cheongju-si
Query!
Country [149]
0
0
Korea, Republic of
Query!
State/province [149]
0
0
Gwangju
Query!
Country [150]
0
0
Korea, Republic of
Query!
State/province [150]
0
0
Incheon
Query!
Country [151]
0
0
Korea, Republic of
Query!
State/province [151]
0
0
Jeju-si
Query!
Country [152]
0
0
Korea, Republic of
Query!
State/province [152]
0
0
Seoul
Query!
Country [153]
0
0
Korea, Republic of
Query!
State/province [153]
0
0
Suwon-si
Query!
Country [154]
0
0
Peru
Query!
State/province [154]
0
0
Cusco
Query!
Country [155]
0
0
Peru
Query!
State/province [155]
0
0
Lima
Query!
Country [156]
0
0
Philippines
Query!
State/province [156]
0
0
Iloilo City
Query!
Country [157]
0
0
Philippines
Query!
State/province [157]
0
0
Lipa City
Query!
Country [158]
0
0
Philippines
Query!
State/province [158]
0
0
Quezon City
Query!
Country [159]
0
0
Poland
Query!
State/province [159]
0
0
Aleksandrów Lódzki
Query!
Country [160]
0
0
Poland
Query!
State/province [160]
0
0
Bialystok
Query!
Country [161]
0
0
Poland
Query!
State/province [161]
0
0
Bielsko Biala
Query!
Country [162]
0
0
Poland
Query!
State/province [162]
0
0
Bydgoszcz
Query!
Country [163]
0
0
Poland
Query!
State/province [163]
0
0
Bystra Slaska
Query!
Country [164]
0
0
Poland
Query!
State/province [164]
0
0
Dobre Miasto
Query!
Country [165]
0
0
Poland
Query!
State/province [165]
0
0
Gdansk
Query!
Country [166]
0
0
Poland
Query!
State/province [166]
0
0
Gizycko
Query!
Country [167]
0
0
Poland
Query!
State/province [167]
0
0
Gorzów Wlkp
Query!
Country [168]
0
0
Poland
Query!
State/province [168]
0
0
Grodzisk Mazowiecki
Query!
Country [169]
0
0
Poland
Query!
State/province [169]
0
0
Karczew
Query!
Country [170]
0
0
Poland
Query!
State/province [170]
0
0
Katowice
Query!
Country [171]
0
0
Poland
Query!
State/province [171]
0
0
Koszalin
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Koscian
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Kraków
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Lubin
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Lublin
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Ostrów Wielkopolski
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Poznan
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Proszowice
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Ruda Slaska
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Rzeszów
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Skierniewice
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Sosnowiec
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Szczecin
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Tarnów
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Trzebnica
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Warszawa
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Wielun
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Wolomin
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Wroclaw
Query!
Country [190]
0
0
Poland
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State/province [190]
0
0
Lódz
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Country [191]
0
0
Poland
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State/province [191]
0
0
Znin
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Country [192]
0
0
Romania
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State/province [192]
0
0
Bragadiru
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Country [193]
0
0
Romania
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State/province [193]
0
0
Bucharest
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Country [194]
0
0
Romania
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State/province [194]
0
0
Constanta
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Country [195]
0
0
Romania
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State/province [195]
0
0
Deva
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Country [196]
0
0
Romania
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State/province [196]
0
0
Iasi
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Country [197]
0
0
Russian Federation
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State/province [197]
0
0
Chelyabinsk
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Country [198]
0
0
Russian Federation
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State/province [198]
0
0
Ekaterinburg
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Country [199]
0
0
Russian Federation
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State/province [199]
0
0
Ivanovo
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Country [200]
0
0
Russian Federation
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State/province [200]
0
0
Izhevsk
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Country [201]
0
0
Russian Federation
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State/province [201]
0
0
Kazan
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Country [202]
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0
Russian Federation
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State/province [202]
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0
Moscow
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Country [203]
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0
Russian Federation
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State/province [203]
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0
Nizhny Novgorod
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Country [204]
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0
Russian Federation
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State/province [204]
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0
Novosibirsk
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Country [205]
0
0
Russian Federation
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State/province [205]
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0
Pyatigorsk
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Country [206]
0
0
Russian Federation
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State/province [206]
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0
Ryazan
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Country [207]
0
0
Russian Federation
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State/province [207]
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Saint - Petersburg
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Country [208]
0
0
Russian Federation
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State/province [208]
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Saint Petersburg
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Country [209]
0
0
Russian Federation
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State/province [209]
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0
Saint-Petersburg
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Country [210]
0
0
Russian Federation
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State/province [210]
0
0
Saratov
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Country [211]
0
0
Russian Federation
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State/province [211]
0
0
Smolensk
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Country [212]
0
0
Russian Federation
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State/province [212]
0
0
St. Petersburg
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Country [213]
0
0
Russian Federation
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State/province [213]
0
0
St.Petersburg
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Country [214]
0
0
Russian Federation
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State/province [214]
0
0
StPetersburg
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Country [215]
0
0
Russian Federation
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State/province [215]
0
0
Tomsk
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Country [216]
0
0
Russian Federation
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State/province [216]
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0
Vladikavkaz
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Country [217]
0
0
Russian Federation
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State/province [217]
0
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Vladimir
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Country [218]
0
0
Russian Federation
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State/province [218]
0
0
Volgograd
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Country [219]
0
0
Russian Federation
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State/province [219]
0
0
Yekaterinburg
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Country [220]
0
0
South Africa
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State/province [220]
0
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Cape Town
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Country [221]
0
0
South Africa
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State/province [221]
0
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Durban
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Country [222]
0
0
South Africa
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State/province [222]
0
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Mowbray
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Country [223]
0
0
South Africa
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State/province [223]
0
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Stanger
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Country [224]
0
0
Spain
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State/province [224]
0
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Barcelona
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Country [225]
0
0
Spain
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State/province [225]
0
0
Lugo
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Country [226]
0
0
Spain
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State/province [226]
0
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Madrid
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Country [227]
0
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Spain
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State/province [227]
0
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Málaga
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Country [228]
0
0
Spain
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State/province [228]
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Oviedo
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Country [229]
0
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Spain
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State/province [229]
0
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Palma de Mallorca
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Country [230]
0
0
Spain
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State/province [230]
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0
Sagunto(Valencia)
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Country [231]
0
0
Spain
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State/province [231]
0
0
Salamanca
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Country [232]
0
0
Spain
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State/province [232]
0
0
Valencia
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Country [233]
0
0
Sweden
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State/province [233]
0
0
Göteborg
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Country [234]
0
0
Sweden
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State/province [234]
0
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Lund
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Country [235]
0
0
Turkey
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State/province [235]
0
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Adana
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Country [236]
0
0
Turkey
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State/province [236]
0
0
Ankara
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Country [237]
0
0
Turkey
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State/province [237]
0
0
Bursa
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Country [238]
0
0
Turkey
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State/province [238]
0
0
Istanbul
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Country [239]
0
0
Turkey
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State/province [239]
0
0
Izmir
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Country [240]
0
0
Turkey
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State/province [240]
0
0
Mersin
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Country [241]
0
0
Ukraine
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State/province [241]
0
0
Chernivtsi
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Country [242]
0
0
Ukraine
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State/province [242]
0
0
Dnipropetrovsk
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Country [243]
0
0
Ukraine
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State/province [243]
0
0
Ivano-Frankivsk
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Country [244]
0
0
Ukraine
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State/province [244]
0
0
Kharkiv
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Country [245]
0
0
Ukraine
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State/province [245]
0
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Kyiv
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Country [246]
0
0
Ukraine
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State/province [246]
0
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Lutsk
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Country [247]
0
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Ukraine
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State/province [247]
0
0
Uzhgorod
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Country [248]
0
0
Ukraine
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State/province [248]
0
0
Vinnytsia
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Country [249]
0
0
United Kingdom
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State/province [249]
0
0
Birmingham
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Country [250]
0
0
United Kingdom
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State/province [250]
0
0
Bradford
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Country [251]
0
0
United Kingdom
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State/province [251]
0
0
Cambridge
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Country [252]
0
0
United Kingdom
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State/province [252]
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Chertsey
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Country [253]
0
0
United Kingdom
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State/province [253]
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Chester
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Country [254]
0
0
United Kingdom
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State/province [254]
0
0
Cottingham
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Country [255]
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0
United Kingdom
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State/province [255]
0
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Darlington
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Country [256]
0
0
United Kingdom
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State/province [256]
0
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Glasgow
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Country [257]
0
0
United Kingdom
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State/province [257]
0
0
Liverpool
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Country [258]
0
0
United Kingdom
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State/province [258]
0
0
Manchester
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Country [259]
0
0
United Kingdom
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State/province [259]
0
0
Nottingham
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Country [260]
0
0
United Kingdom
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State/province [260]
0
0
Plymouth
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Country [261]
0
0
United Kingdom
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State/province [261]
0
0
Portsmouth
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Country [262]
0
0
United Kingdom
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State/province [262]
0
0
Soham
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Country [263]
0
0
United Kingdom
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State/province [263]
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Somerset
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Country [264]
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0
United Kingdom
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State/province [264]
0
0
Stevenage
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Country [265]
0
0
United Kingdom
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State/province [265]
0
0
Stockton
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Country [266]
0
0
Vietnam
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State/province [266]
0
0
Hanoi
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Country [267]
0
0
Vietnam
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State/province [267]
0
0
Ho Chi Minh
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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
The purpose of this study is to characterize the safety profile of benralizumab
administration in asthma patients who have completed one of the three predecessor studies:
D3250C00017, D3250C00018 or D3250C00020.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02258542
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
William W. Busse, M.D., Professor of Medicine
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Address
0
0
Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
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0
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02258542
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