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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

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levels.When any eosinophil cohort is full, subjects in the completed cohort will not be randomised and will be withdrawn from the study.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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Benralizumab Arm A

Benralizumab Arm B

Benralizumab Arm C

Placebo

Arm Description

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

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

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

NCT ID

NCT02155660

First Posted

May 20, 2014

Last Updated

June 7, 2019

Sponsor

AstraZeneca

Collaborators

MedImmune LLC

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

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

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

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

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

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

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

Time Frame

Immediately following first IP up to week 56

Title

Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL

Description

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

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

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

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

Country

United States

Facility Name

Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

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

Country

United States

Facility Name

Research Site

City

Peninsula

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Research Site

City

Placentia

State/Province

California

ZIP/Postal Code

92870

Country

United States

Facility Name

Research Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Research Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Research Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Research Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Research Site

City

Chiefland

State/Province

Florida

ZIP/Postal Code

32626

Country

United States

Facility Name

Research Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33759

Country

United States

Facility Name

Research Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Research Site

City

Coconut Creek

State/Province

Florida

ZIP/Postal Code

33066

Country

United States

Facility Name

Research Site

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Research Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Research Site

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

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

Country

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

Country

United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33010

Country

United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

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

Country

United States

Facility Name

Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34744

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Research Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Research Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Research Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Research Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Research Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

Research Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

Research Site

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83687

Country

United States

Facility Name

Research Site

City

Evergreen Park

State/Province

Illinois

ZIP/Postal Code

60805

Country

United States

Facility Name

Research Site

City

O'Fallon

State/Province

Illinois

ZIP/Postal Code

62269

Country

United States

Facility Name

Research Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

Research Site

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

Country

United States

Facility Name

Research Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Research Site

City

Henderson

State/Province

Kentucky

ZIP/Postal Code

42420

Country

United States

Facility Name

Research Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Research Site

City

Opelousas

State/Province

Louisiana

ZIP/Postal Code

70570

Country

United States

Facility Name

Research Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71106

Country

United States

Facility Name

Research Site

City

Sunset

State/Province

Louisiana

ZIP/Postal Code

70584

Country

United States

Facility Name

Research Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Research Site

City

Lutherville

State/Province

Maryland

ZIP/Postal Code

21093

Country

United States

Facility Name

Research Site

City

White Marsh

State/Province

Maryland

ZIP/Postal Code

21162

Country

United States

Facility Name

Research Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Research Site

City

Marlborough

State/Province

Massachusetts

ZIP/Postal Code

01752

Country

United States

Facility Name

Research Site

City

Buckley

State/Province

Michigan

ZIP/Postal Code

49620

Country

United States

Facility Name

Research Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Research Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Research Site

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Research Site

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Research Site

City

Woodbury

State/Province

Minnesota

ZIP/Postal Code

55125

Country

United States

Facility Name

Research Site

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

Research Site

City

Port Gibson

State/Province

Mississippi

ZIP/Postal Code

39150

Country

United States

Facility Name

Research Site

City

Belton

State/Province

Missouri

ZIP/Postal Code

64012

Country

United States

Facility Name

Research Site

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63033

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63136

Country

United States

Facility Name

Research Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Research Site

City

Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89146

Country

United States

Facility Name

Research Site

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

Research Site

City

Union

State/Province

New Jersey

ZIP/Postal Code

07083

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10459

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Research Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11236

Country

United States

Facility Name

Research Site

City

Great Neck

State/Province

New York

ZIP/Postal Code

11023

Country

United States

Facility Name

Research Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Research Site

City

New Windsor

State/Province

New York

ZIP/Postal Code

12553

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

Potsdam

State/Province

New York

ZIP/Postal Code

13676

Country

United States

Facility Name

Research Site

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Research Site

City

Calabash

State/Province

North Carolina

ZIP/Postal Code

28467

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Research Site

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Research Site

City

Mooresville

State/Province

North Carolina

ZIP/Postal Code

28117

Country

United States

Facility Name

Research Site

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Facility Name

Research Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Research Site

City

Chardon

State/Province

Ohio

ZIP/Postal Code

44024

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Research Site

City

Marion

State/Province

Ohio

ZIP/Postal Code

43302

Country

United States

Facility Name

Research Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Research Site

City

Clackamas

State/Province

Oregon

ZIP/Postal Code

97015-6804

Country

United States

Facility Name

Research Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Research Site

City

Monroeville

State/Province

Pennsylvania

ZIP/Postal Code

15146

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19142

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Research Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29412

Country

United States

Facility Name

Research Site

City

Hodges

State/Province

South Carolina

ZIP/Postal Code

29653

Country

United States

Facility Name

Research Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Research Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Research Site

City

Tullahoma

State/Province

Tennessee

ZIP/Postal Code

37388

Country

United States

Facility Name

Research Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Research Site

City

Duncanville

State/Province

Texas

ZIP/Postal Code

75116

Country

United States

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77036

Country

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

Country

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

Country

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

Research Site

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

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

Moderate to Very Severe Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial