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Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History (TERRANOVA)

Primary Purpose

Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Benralizumab Arm A
Benralizumab Arm B
Benralizumab Arm C
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Very Severe Chronic Obstructive Pulmonary Disease focused on measuring Obstructive Lung Diseases, Chronic Obstructive Pulmonary Disease, Lung Disease, Bronchial Diseases, COPD Exacerbation, Respiratory Tract Diseases

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:.

  • Informed consent.
  • Subjects 40-85 y.o.
  • Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%.

    -≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1.

  • Modified Medical Research Council (mMRC) score ≥1 at Visit 1.
  • Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1.
  • Tobacco history of ≥10 pack-years.
  • Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
  • Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose.
  • Compliance with maintenance therapy during run-in ≥70%.
  • Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.

Exclusion criteria:

  • Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
  • Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration.
  • Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
  • Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.
  • Acute upper or lower respiratory infection requiring antibiotics within 2 weeks prior to Visit1 or during the enrolment and run-in period.
  • Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
  • Pregnant, breastfeeding, or lactating women.
  • Risk factors for pneumonia
  • History of anaphylaxis to any other biologic therapy.
  • Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
  • Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
  • Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
  • Evidence of active tuberculosis (TB) without an appropriate course of treatment.
  • Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
  • Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
  • Previous treatment with benralizumab.
  • Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Benralizumab Arm A

Benralizumab Arm B

Benralizumab Arm C

Placebo

Arm Description

Benralizumab administered subcutaneously

Benralizumab administered subcutaneously

Benralizumab administered subcutaneously

Placebo administered subcutaneously

Outcomes

Primary Outcome Measures

Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.

Secondary Outcome Measures

Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL
A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL
Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.
Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL
SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.
Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL
CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.
Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL
The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.
Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL
The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.
Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred.
Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO.
Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.
Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL
A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.
Time to First COPD Exacerbation
Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.
Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL
Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.
Duration of Study Treatment Administration
Duration of study treatment is calculated from first dose date to last dose date + 1 day.
Serum Concentration of Benralizumab
PK serum samples were collected pre-dose at each visit.
Immunogenicity of Benralizumab
Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.

Full Information

First Posted
May 20, 2014
Last Updated
June 7, 2019
Sponsor
AstraZeneca
Collaborators
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02155660
Brief Title
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
Acronym
TERRANOVA
Official Title
A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2014 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
MedImmune LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Keywords
Obstructive Lung Diseases, Chronic Obstructive Pulmonary Disease, Lung Disease, Bronchial Diseases, COPD Exacerbation, Respiratory Tract Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benralizumab Arm A
Arm Type
Experimental
Arm Description
Benralizumab administered subcutaneously
Arm Title
Benralizumab Arm B
Arm Type
Experimental
Arm Description
Benralizumab administered subcutaneously
Arm Title
Benralizumab Arm C
Arm Type
Experimental
Arm Description
Benralizumab administered subcutaneously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Benralizumab Arm A
Intervention Description
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Intervention Type
Drug
Intervention Name(s)
Benralizumab Arm B
Intervention Description
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Intervention Type
Drug
Intervention Name(s)
Benralizumab Arm C
Intervention Description
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Primary Outcome Measure Information:
Title
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Description
A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
Time Frame
Immediately following the first IP dose through week 56
Secondary Outcome Measure Information:
Title
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL
Description
A COPD exacerbation is defined by symptomatic worsening of COPD requiring: Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or Use of antibiotics; and/or An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
Time Frame
Immediately following the first IP dose through week 56
Title
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL
Description
Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.
Time Frame
First IP up to end of treatment Week 56
Title
Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL
Description
SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.
Time Frame
First IP up to Week 56
Title
Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL
Description
CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.
Time Frame
First IP up to Week 56
Title
Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL
Description
The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.
Time Frame
First IP up to Week 56
Title
Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL
Description
The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.
Time Frame
First IP up to Week 56
Title
Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL
Description
Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.
Time Frame
First IP up to Week 56
Title
Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL
Description
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred.
Time Frame
Immediately following first IP up to week 56
Title
Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL
Description
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO.
Time Frame
Immediately following first IP up to week 56
Title
Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL
Description
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event.
Time Frame
Immediately following first IP up to week 56
Title
Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Description
The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
Time Frame
Immediately following the first IP dose through week 56
Title
Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL
Description
A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.
Time Frame
Immediately following first IP dose up to week 56
Title
Time to First COPD Exacerbation
Description
Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.
Time Frame
Immediately following IP dose to Week 56
Title
Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL
Description
Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.
Time Frame
Immediately following the first IP dose through week 56
Title
Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL
Description
Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.
Time Frame
Immediately following first IP dose up to Week 56
Title
Duration of Study Treatment Administration
Description
Duration of study treatment is calculated from first dose date to last dose date + 1 day.
Time Frame
From first dose date to last dose date, 48 weeks per protocol.
Title
Serum Concentration of Benralizumab
Description
PK serum samples were collected pre-dose at each visit.
Time Frame
Pre-first dose and pre-dose at end of treatment (week 56).
Title
Immunogenicity of Benralizumab
Description
Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.
Time Frame
Pre-treatment until end of follow-up, week 60 per protocol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:. Informed consent. Subjects 40-85 y.o. Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65%. -≥2 moderate or ≥1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. Modified Medical Research Council (mMRC) score ≥1 at Visit 1. Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. Tobacco history of ≥10 pack-years. Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1. Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose. Compliance with maintenance therapy during run-in ≥70%. Blood eosinophils due to subject's stratification and cap for blood eosinophil levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study. Exclusion criteria: Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety-study findings or their interpretation or subject's ability to complete the entire study duration. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period. Acute upper or lower respiratory infection requiring antibiotics within 2 weeks prior to Visit1 or during the enrolment and run-in period. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period. Pregnant, breastfeeding, or lactating women. Risk factors for pneumonia History of anaphylaxis to any other biologic therapy. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure. Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1. Evidence of active tuberculosis (TB) without an appropriate course of treatment. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable). Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. Previous treatment with benralizumab. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartolome R. Celli, MD
Organizational Affiliation
Brigham and Women's Hospital, Pulmonary Division, 75 Francis Street, PBB Clinics 3, Boston, MA 02115
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Research Site
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Research Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Research Site
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
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United States
Facility Name
Research Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
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United States
Facility Name
Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Research Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Research Site
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Research Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Research Site
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
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United States
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Research Site
City
Peninsula
State/Province
California
ZIP/Postal Code
90505
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United States
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Research Site
City
Placentia
State/Province
California
ZIP/Postal Code
92870
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United States
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Research Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
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United States
Facility Name
Research Site
City
Westminster
State/Province
California
ZIP/Postal Code
92683
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United States
Facility Name
Research Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
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United States
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Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
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United States
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Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
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United States
Facility Name
Research Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
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United States
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Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
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United States
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Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
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United States
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Research Site
City
Coconut Creek
State/Province
Florida
ZIP/Postal Code
33066
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United States
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Research Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
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United States
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Research Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
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United States
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Research Site
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
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United States
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Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
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United States
Facility Name
Research Site
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
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United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
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United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
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United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
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United States
Facility Name
Research Site
City
Homestead
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
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United States
Facility Name
Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
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United States
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Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
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United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
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United States
Facility Name
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City
Miami
State/Province
Florida
ZIP/Postal Code
33147
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United States
Facility Name
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City
Miami
State/Province
Florida
ZIP/Postal Code
33155
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United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
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United States
Facility Name
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City
Miami
State/Province
Florida
ZIP/Postal Code
33174
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United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
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United States
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City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
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United States
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City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
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United States
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Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
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United States
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City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
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United States
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City
Atlanta
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Georgia
ZIP/Postal Code
30331
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United States
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City
Blue Ridge
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Georgia
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30513
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United States
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Lawrenceville
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Georgia
ZIP/Postal Code
30046
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United States
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City
Woodstock
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Georgia
ZIP/Postal Code
30189
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United States
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City
Nampa
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Idaho
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83687
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United States
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City
Evergreen Park
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Illinois
ZIP/Postal Code
60805
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United States
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Research Site
City
O'Fallon
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Illinois
ZIP/Postal Code
62269
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United States
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City
Peoria
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Illinois
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61602
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United States
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City
River Forest
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Illinois
ZIP/Postal Code
60305
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United States
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City
Topeka
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Kansas
ZIP/Postal Code
66606
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United States
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City
Henderson
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Kentucky
ZIP/Postal Code
42420
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United States
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City
Owensboro
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Kentucky
ZIP/Postal Code
42303
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United States
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City
Opelousas
State/Province
Louisiana
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70570
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United States
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City
Shreveport
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Louisiana
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71106
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United States
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City
Sunset
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Louisiana
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70584
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United States
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City
Bangor
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Maine
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04401
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United States
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City
Lutherville
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Maryland
ZIP/Postal Code
21093
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United States
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City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
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United States
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City
Fall River
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Massachusetts
ZIP/Postal Code
02720
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United States
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City
Marlborough
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Massachusetts
ZIP/Postal Code
01752
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United States
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City
Buckley
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Michigan
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49620
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United States
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City
Kalamazoo
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Michigan
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49009
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United States
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City
Troy
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Michigan
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48085
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United States
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City
Edina
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Minnesota
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55435
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United States
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City
Fridley
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Minnesota
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55432
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United States
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City
Woodbury
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Minnesota
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55125
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United States
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Picayune
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39466
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United States
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Port Gibson
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Mississippi
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39150
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United States
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City
Belton
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Missouri
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64012
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United States
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City
Florissant
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Missouri
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63033
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United States
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City
Saint Louis
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Missouri
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63136
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United States
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City
Missoula
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Montana
ZIP/Postal Code
59808
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United States
Facility Name
Research Site
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
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United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
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United States
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City
Las Vegas
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Nevada
ZIP/Postal Code
89146
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United States
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City
Marlton
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New Jersey
ZIP/Postal Code
08053
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United States
Facility Name
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City
Union
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New Jersey
ZIP/Postal Code
07083
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United States
Facility Name
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City
Bronx
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New York
ZIP/Postal Code
10459
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United States
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City
Bronx
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New York
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10461
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United States
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City
Brooklyn
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New York
ZIP/Postal Code
11236
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United States
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Great Neck
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New York
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11023
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United States
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City
Mineola
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New York
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11501
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United States
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City
New Windsor
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New York
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12553
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United States
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City
New York
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New York
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10016
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United States
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City
Potsdam
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New York
ZIP/Postal Code
13676
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United States
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City
Burlington
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North Carolina
ZIP/Postal Code
27215
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United States
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Calabash
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North Carolina
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28467
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United States
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Charlotte
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North Carolina
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28277
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United States
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Hickory
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North Carolina
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28601
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United States
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Mooresville
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North Carolina
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28117
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United States
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New Bern
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North Carolina
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28562
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United States
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Shelby
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North Carolina
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28150
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United States
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Chardon
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Ohio
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44024
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United States
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Cincinnati
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Ohio
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45242
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United States
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Columbus
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Ohio
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43213
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United States
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Columbus
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Ohio
ZIP/Postal Code
43214
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United States
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City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
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United States
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Research Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
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United States
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Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
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United States
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Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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United States
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Research Site
City
Clackamas
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Oregon
ZIP/Postal Code
97015-6804
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United States
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Medford
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Oregon
ZIP/Postal Code
97504
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United States
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City
Monroeville
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Pennsylvania
ZIP/Postal Code
15146
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United States
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City
Philadelphia
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Pennsylvania
ZIP/Postal Code
19142
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United States
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City
Pittsburgh
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Pennsylvania
ZIP/Postal Code
15213
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United States
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City
Pittsburgh
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Pennsylvania
ZIP/Postal Code
15243
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United States
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City
Uniontown
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Pennsylvania
ZIP/Postal Code
15401
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United States
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City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
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United States
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Research Site
City
Hodges
State/Province
South Carolina
ZIP/Postal Code
29653
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United States
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Research Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
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United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
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United States
Facility Name
Research Site
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
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United States
Facility Name
Research Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
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United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
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United States
Facility Name
Research Site
City
Duncanville
State/Province
Texas
ZIP/Postal Code
75116
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United States
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
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United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
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United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
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United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
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United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
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United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
78756
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United States
Facility Name
Research Site
City
Huntsville
State/Province
Texas
ZIP/Postal Code
77340
Country
United States
Facility Name
Research Site
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Research Site
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Research Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75604
Country
United States
Facility Name
Research Site
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Research Site
City
Sealy
State/Province
Texas
ZIP/Postal Code
77474
Country
United States
Facility Name
Research Site
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Research Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98208
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26357
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Research Site
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
C1440BRR
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Research Site
City
Concepción del Uruguay
ZIP/Postal Code
3260
Country
Argentina
Facility Name
Research Site
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5014KEH
Country
Argentina
Facility Name
Research Site
City
Florencio Varela
ZIP/Postal Code
1888
Country
Argentina
Facility Name
Research Site
City
Florida
ZIP/Postal Code
1638
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
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City
Mar del Plata
ZIP/Postal Code
B7600GNY
Country
Argentina
Facility Name
Research Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Research Site
City
Mendoza
ZIP/Postal Code
M5500GIP
Country
Argentina
Facility Name
Research Site
City
Nueve de julio
ZIP/Postal Code
B6500EZL
Country
Argentina
Facility Name
Research Site
City
Quilmes
ZIP/Postal Code
B1878FNR
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000DEJ
Country
Argentina
Facility Name
Research Site
City
San Fernando
ZIP/Postal Code
1646
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
Research Site
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Research Site
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Facility Name
Research Site
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Research Site
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Research Site
City
New Lambton
ZIP/Postal Code
2310
Country
Australia
Facility Name
Research Site
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Research Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Research Site
City
Jambes
ZIP/Postal Code
5100
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Malmedy
ZIP/Postal Code
4960
Country
Belgium
Facility Name
Research Site
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
Research Site
City
Veurne
ZIP/Postal Code
8630
Country
Belgium
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60864190
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Research Site
City
Santo Andre
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04020060
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Research Site
City
Sorocaba
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Research Site
City
Vitória
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Research Site
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Research Site
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Research Site
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Research Site
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
Research Site
City
Petrich
ZIP/Postal Code
2850
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Research Site
City
Sandanski
ZIP/Postal Code
2800
Country
Bulgaria
Facility Name
Research Site
City
Silistra
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1002
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Research Site
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
Research Site
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Research Site
City
Yambol
ZIP/Postal Code
8600
Country
Bulgaria
Facility Name
Research Site
City
Curico
ZIP/Postal Code
3341643
Country
Chile
Facility Name
Research Site
City
Quillota
ZIP/Postal Code
2260000
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500698
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500800
Country
Chile
Facility Name
Research Site
City
Talca
ZIP/Postal Code
3465584
Country
Chile
Facility Name
Research Site
City
Armenia
ZIP/Postal Code
630004
Country
Colombia
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
80001
Country
Colombia
Facility Name
Research Site
City
Bogota
ZIP/Postal Code
111511
Country
Colombia
Facility Name
Research Site
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Research Site
City
Bogotá
Country
Colombia
Facility Name
Research Site
City
Cali
ZIP/Postal Code
76001000
Country
Colombia
Facility Name
Research Site
City
Manizales
ZIP/Postal Code
17001
Country
Colombia
Facility Name
Research Site
City
Medellin
ZIP/Postal Code
5001000
Country
Colombia
Facility Name
Research Site
City
Medillin
Country
Colombia
Facility Name
Research Site
City
Petrinja
ZIP/Postal Code
44250
Country
Croatia
Facility Name
Research Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Research Site
City
København NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Research Site
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Research Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Research Site
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Research Site
City
Bois Guillaume
ZIP/Postal Code
76031
Country
France
Facility Name
Research Site
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Research Site
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Research Site
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Research Site
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
NIMES Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
Research Site
City
Orléans Cedex 2
ZIP/Postal Code
45100
Country
France
Facility Name
Research Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9372212
Country
Israel
Facility Name
Research Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
IL-
Country
Israel
Facility Name
Research Site
City
Durango
ZIP/Postal Code
43080
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44200
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Research Site
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Research Site
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Research Site
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Research Site
City
Greenlane
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Research Site
City
Hamilton West
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Research Site
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Research Site
City
Bodø
ZIP/Postal Code
N-8092
Country
Norway
Facility Name
Research Site
City
Kolbjørnsvik
ZIP/Postal Code
N-4816
Country
Norway
Facility Name
Research Site
City
Svelvik
ZIP/Postal Code
3060
Country
Norway
Facility Name
Research Site
City
Cusco
ZIP/Postal Code
CUSCO 01
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L41
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 1
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 21
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 33
Country
Peru
Facility Name
Research Site
City
Piura
Country
Peru
Facility Name
Research Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Research Site
City
Lipa City
Country
Philippines
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1101
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1109
Country
Philippines
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-231
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Gorzów Wlkp
ZIP/Postal Code
66-400
Country
Poland
Facility Name
Research Site
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Research Site
City
Karczew
ZIP/Postal Code
05-480
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-901
Country
Poland
Facility Name
Research Site
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Research Site
City
Ostrów Wielkopolski
ZIP/Postal Code
63-400
Country
Poland
Facility Name
Research Site
City
Ruda Śląska
ZIP/Postal Code
41-707
Country
Poland
Facility Name
Research Site
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Research Site
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Research Site
City
Starachowice
ZIP/Postal Code
27-200
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Research Site
City
Słupca
ZIP/Postal Code
62-400
Country
Poland
Facility Name
Research Site
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
53-301
Country
Poland
Facility Name
Research Site
City
Żnin
ZIP/Postal Code
88-400
Country
Poland
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Facility Name
Research Site
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
Research Site
City
Kamnik
ZIP/Postal Code
1241
Country
Slovenia
Facility Name
Research Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Research Site
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Research Site
City
Goteborg
ZIP/Postal Code
405 30
Country
Sweden
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Research Site
City
Helsingborg
ZIP/Postal Code
252 20
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Research Site
City
Malmo
ZIP/Postal Code
21152
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
114 46
Country
Sweden
Facility Name
Research Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
New-Taipei
ZIP/Postal Code
22056
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Bangkoknoi
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10600
Country
Thailand
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Research Site
City
Muang,
ZIP/Postal Code
55000
Country
Thailand
Facility Name
Research Site
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06280
Country
Turkey
Facility Name
Research Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34020
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Research Site
City
İstanbul
ZIP/Postal Code
34844
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Research Site
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Research Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Research Site
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Research Site
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49051
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76012
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61035
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Research Site
City
Lutsk
ZIP/Postal Code
43000
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79066
Country
Ukraine
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
ZIP/Postal Code
69068
Country
Ukraine
Facility Name
Research Site
City
Can Tho
ZIP/Postal Code
900000
Country
Vietnam
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
31575508
Citation
Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
Results Reference
derived
PubMed Identifier
31112385
Citation
Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2563&filename=D3251C00004%20-%20%20%20Statistical%20Analysis%20Plan_Redacted.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2563&filename=Terranova%20CSP%20and%20last%20amendment_Redacted.pdf
Description
Related Info

Learn more about this trial

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

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