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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02808819




Registration number
NCT02808819
Ethics application status
Date submitted
7/06/2016
Date registered
22/06/2016
Date last updated
13/04/2021

Titles & IDs
Public title
A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting ß2 Agonist
Scientific title
A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting ß2 Agonist (MELTEMI)
Secondary ID [1] 0 0
D3250C00037
Universal Trial Number (UTN)
Trial acronym
MELTEMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Benralizumab
Treatment: Other - Benralizumab

Other: Benralizumab Arm A - Benralizumab administered subcutaneously every 4 weeks

Other: Benralizumab Arm B - Benralizumab administered subcutaneously every 8 weeks


Treatment: Other: Benralizumab
Benralizumab administered subcutaneously every 4 weeks

Treatment: Other: Benralizumab
Benralizumab administered subcutaneously every 8 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Basophils, Full Analysis Set
Timepoint [1] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [2] 0 0
Change From Baseline in Leukocytes, Full Analysis Set
Timepoint [2] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [3] 0 0
Change From Baseline in Lymphocytes, Full Analysis Set
Timepoint [3] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [4] 0 0
Change From Baseline in Neutrophils, Full Analysis Set
Timepoint [4] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [5] 0 0
Change From Baseline in Monocytes, Full Analysis Set
Timepoint [5] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [6] 0 0
Change From Baseline in Platelets, Full Analysis Set
Timepoint [6] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [7] 0 0
Change From Baseline in Hematocrit, Full Analysis Set
Timepoint [7] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [8] 0 0
Change From Baseline in Erythrocytes, Full Analysis Set
Timepoint [8] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [9] 0 0
Change From Baseline in Hemoglobin, Full Analysis Set
Timepoint [9] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [10] 0 0
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set
Timepoint [10] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [11] 0 0
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set
Timepoint [11] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [12] 0 0
Change From Baseline in Bilirubin, Full Analysis Set
Timepoint [12] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Secondary outcome [1] 0 0
Number of Participants With Asthma Exacerbations During Study Period
Timepoint [1] 0 0
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with asthma exacerbation during this period is presented.
Secondary outcome [2] 0 0
Number of Participants Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Timepoint [2] 0 0
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with health care encounters during this period is presented.
Secondary outcome [3] 0 0
Change of Blood Eosinophils Count
Timepoint [3] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Secondary outcome [4] 0 0
Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study
Timepoint [4] 0 0
From week 0 to week 184 in study treatment period and plus 12 weeks follow up period
Secondary outcome [5] 0 0
Duration of Exposure
Timepoint [5] 0 0
From week 0 to week 184 in study treatment period

Eligibility
Key inclusion criteria
* Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
* Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
* Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
* For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
* 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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, 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 study or their interpretations
* Impede the patient's ability to complete the entire duration of study
* A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy
* Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the 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
* Current malignancy or malignancy that developed during the 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).
* 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 IP
* Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
* Planned major surgical procedures during the conduct of the study
* Previous participation in the present study
* Concurrent enrolment in another drug-related interventional clinical trial
* AstraZeneca staff involved in the planning and/or conduct of the study
* Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
* Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor
* Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2020
Sample size
Target
Accrual to date
Final
447
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Frankston
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment hospital [4] 0 0
Research Site - Randwick
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
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Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
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United States of America
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North Carolina
Country [13] 0 0
United States of America
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Ohio
Country [14] 0 0
United States of America
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Oklahoma
Country [15] 0 0
United States of America
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Pennsylvania
Country [16] 0 0
United States of America
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South Carolina
Country [17] 0 0
United States of America
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South Dakota
Country [18] 0 0
United States of America
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Texas
Country [19] 0 0
United States of America
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Virginia
Country [20] 0 0
United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad de Buenos Aire
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Argentina
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La Plata
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Argentina
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Mendoza
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Bulgaria
State/province [25] 0 0
Pazardzhik
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Pernik
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Petrich
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Ruse
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sliven
Country [30] 0 0
Bulgaria
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Vratsa
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Quillota
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Chile
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Talcahuano
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Chile
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Valparaiso
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Czechia
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Karlovy Vary
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Czechia
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Plzen
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Czechia
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Praha
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Czechia
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Rokycany
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France
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Brest Cedex 2
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France
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Dijon Cedex
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France
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Le Kremlin Bicêtre
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France
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Le Mans Cedex
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France
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Lyon Cedex 04
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France
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Marseille Cedex 20
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France
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Montpellier
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France
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Paris
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France
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Pringy Cedex
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France
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Saint Pierre
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France
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Strasbourg Cedex
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France
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Toulouse Cedex 9
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Germany
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Aschaffenburg
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Germany
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Bamberg
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Berlin
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Germany
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Frankfurt/Main
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Frankfurt
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Germany
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Geesthacht
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Germany
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Grosshansdorf
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Germany
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Hamburg
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Hannover
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Marburg
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Germany
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Rüdersdorf
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Poland
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Aleksandrów Lódzki
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Bialystok
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Bydgoszcz
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Dobre Miasto
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Gdansk
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Gorzów Wlkp
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Grodzisk Mazowiecki
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Koscian
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Kraków
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Lublin
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Ostrów Wielkopolski
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Poznan
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Proszowice
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Ruda Slaska
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Rzeszów
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Skierniewice
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Sosnowiec
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Tarnów
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Trzebnica
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Warszawa
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Wielun
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Wolomin
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Poland
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Wroclaw
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Poland
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Lódz
Country [92] 0 0
Poland
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Znin
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Russian Federation
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Ekaterinburg
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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St. Petersburg
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Russian Federation
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Vladikavkaz
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Russian Federation
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Volgograd
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Russian Federation
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Yekaterinburg
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Spain
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Málaga
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Spain
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Palma de Mallorca
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Spain
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Sagunto(Valencia)
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Spain
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Salamanca
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Spain
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Valencia
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Bursa
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Turkey
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Istanbul
Country [110] 0 0
Ukraine
State/province [110] 0 0
Dnipro
Country [111] 0 0
Ukraine
State/province [111] 0 0
Ivano-Frankivsk
Country [112] 0 0
Ukraine
State/province [112] 0 0
Kharkiv Region
Country [113] 0 0
Ukraine
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Kyiv
Country [114] 0 0
Ukraine
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Lutsk
Country [115] 0 0
Ukraine
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Vinnytsia
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Chertsey
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United Kingdom
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Cottingham
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United Kingdom
State/province [120] 0 0
Nottingham
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United Kingdom
State/province [121] 0 0
Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).
Trial website
https://clinicaltrials.gov/study/NCT02808819
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02808819