Clinical trial NCT02258542: A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
Official 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 β2 Agonist (BORA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 2133
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI).

Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU.

At the time of the first interim analysis in Japanese patients, the study regimen for all patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.

Eligibility 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.

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

Primary outcomes:
measure: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
timeFrame: Week 56
measure: Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
Secondary outcomes:
measure: Number of Overall Patients With Asthma Exacerbations During Study Period
timeFrame: From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
measure: Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)
timeFrame: From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
measure: Change From Baseline in Pre-bronchodilator FEV1 (L)
timeFrame: Week 56
measure: Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Post-bronchodilator FEV1 (L)
timeFrame: Week 56
measure: Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
timeFrame: Week 56
measure: Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
timeFrame: Week 56
measure: Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Change of Blood Eosinophil Levels' Measurement in Overall Patients
timeFrame: Week 56
measure: Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
timeFrame: Week 108
measure: Change From Baseline in EQ-5D-5L Visual Analog Scale
timeFrame: Week 56
measure: Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: Week 68
measure: Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
timeFrame: Week 56
measure: Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: Week 68
measure: Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
timeFrame: Week 108
measure: 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
timeFrame: From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
measure: 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)
timeFrame: Baseline and Week 108
measure: Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
timeFrame: Week 0 and Week 56
measure: Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)
timeFrame: Baseline and Week 108
measure: Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
timeFrame: 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
measure: Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)
timeFrame: 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
Other outcomes:
Locations:
city: Andalusia
country: United States
facility: Research Site
state: Alabama
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city: Clearwater
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city: Falls Church
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city: Madison
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Buenos Aires
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city: Caba
country: Argentina
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city: Caba
country: Argentina
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city: Caba
country: Argentina
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city: Ciudad Autónoma de Bs. As.
country: Argentina
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city: Concepción del Uruguay
country: Argentina
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city: Corrientes
country: Argentina
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city: Córdoba
country: Argentina
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city: Florida
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city: Godoy Cruz
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country: Argentina
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city: Mar del Plata
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country: Argentina
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country: Argentina
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country: Argentina
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city: San Miguel de Tucuman
country: Argentina
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city: Bedford Park
country: Australia
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city: Box Hill
country: Australia
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city: Clayton
country: Australia
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city: Concord
country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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city: Randwick
country: Australia
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city: Woolloongabba
country: Australia
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city: Porto Alegre
country: Brazil
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country: Brazil
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city: Porto Alegre
country: Brazil
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city: Santo Andre
country: Brazil
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city: Sao Paulo
country: Brazil
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city: Sorocaba
country: Brazil
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city: São Paulo
country: Brazil
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city: Dupnitsa
country: Bulgaria
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city: Pazardzhik
country: Bulgaria
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city: Pernik
country: Bulgaria
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city: Petrich
country: Bulgaria
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city: Pleven
country: Bulgaria
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city: Ruse
country: Bulgaria
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city: Samokov
country: Bulgaria
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city: Sliven
country: Bulgaria
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city: Sofia
country: Bulgaria
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country: Bulgaria
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city: Stara Zagora
country: Bulgaria
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city: Varna
country: Bulgaria
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city: Velingrad
country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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city: Calgary
country: Canada
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state: Alberta
city: Sherwood Park
country: Canada
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city: Vancouver
country: Canada
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state: British Columbia
city: Vancouver
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city: Burlington
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city: Hamilton
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city: Montreal
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state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Montreal
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: France
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country: France
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country: France
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country: France
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city: Lyon Cedex 4
country: France
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country: France
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country: France
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city: Paris
country: France
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country: France
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city: Pringy Cedex
country: France
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country: France
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city: Strasbourg Cedex
country: France
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city: Toulouse CEDEX 09
country: France
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city: Aschaffenburg
country: Germany
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city: Bamberg
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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country: Germany
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city: Frankfurt am Main
country: Germany
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city: Frankfurt/Main
country: Germany
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city: Frankfurt
country: Germany
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country: Germany
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city: Grosshansdorf
country: Germany
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country: Germany
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country: Germany
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city: Hannover
country: Germany
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city: Hannover
country: Germany
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country: Germany
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country: Germany
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city: Leipzig
country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: München
country: Germany
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city: Neu-Isenburg
country: Germany
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city: Rostock
country: Germany
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country: Germany
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country: Germany
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city: Asahi-shi
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Sumida-ku
country: Japan
facility: Research Site
city: Takamatsu-shi
country: Japan
facility: Research Site
city: Toshima-ku
country: Japan
facility: Research Site
city: Tsukubo-gun
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Anyang-si
country: Korea, Republic of
facility: Research Site
city: Bucheon-si
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Cheongju-si
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jeju-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Cusco
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Lipa City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Aleksandrów Łódzki
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bielsko Biala
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Bystra Śląska
country: Poland
facility: Research Site
city: Dobre Miasto
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Giżycko
country: Poland
facility: Research Site
city: Gorzów Wlkp
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Karczew
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Koszalin
country: Poland
facility: Research Site
city: Kościan
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lubin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostrów Wielkopolski
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Proszowice
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Sosnowiec
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Tarnów
country: Poland
facility: Research Site
city: Trzebnica
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wieluń
country: Poland
facility: Research Site
city: Wołomin
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Żnin
country: Poland
facility: Research Site
city: Bragadiru
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Deva
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint - Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: StPetersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Vladikavkaz
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Mowbray
country: South Africa
facility: Research Site
city: Stanger
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Sagunto(Valencia)
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: İstanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Chertsey
country: United Kingdom
facility: Research Site
city: Chester
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Darlington
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
city: Soham
country: United Kingdom
facility: Research Site
city: Somerset
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Stockton
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
name: William W. Busse, M.D., Professor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17.
citation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8.