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Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation (BOREAS)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dupilumab SAR231893
Inhaled Corticosteroid
Inhaled Long-Acting Beta Agonist
Inhaled Long-Acting Muscarinic Antagonist
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Participants with a physician diagnosis of COPD who meet the following criteria at screening:

    • Current or former smokers with a smoking history of ≥10 pack-years.
    • Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%).
    • Medical Research Council (MRC) Dyspnea Scale grade ≥2.
    • Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
    • Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization or observation >24 hours in emergency department/urgent care facility.
    • Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
  • Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.

Exclusion criteria:

  • COPD diagnosis for less than 12 months prior to randomization.
  • A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
  • Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
  • Cor pulmonale, evidence of right cardiac failure.
  • Treatment with oxygen of more than 12 hours per day.
  • Hypercapnia requiring Bi-level ventilation.
  • AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
  • Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
  • History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included).
  • Diagnosis of α-1 anti-trypsin deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • SEC Clinical Research, LLC-Site Number:8400030
  • Clinical Research Center of Alabama, LLC-Site Number:8400041
  • UAB Lung Health Center-Site Number:8400013
  • SEC Clinical Research, LLC-Site Number:8400059
  • Pulmonary Associates of Mobile, P.C.-Site Number:8400057
  • Asthma and Allergy Associates, PC-Site Number:8400034
  • Clinical Research Of West Florida Inc-Site Number:8400010
  • Finlay Medical Research-Site Number:8400014
  • Project 4 research, Inc.-Site Number:8400023
  • Finlay Medical Research-Site Number:8400062
  • Reed Medical Research-Site Number:8400079
  • Renstar Medical Research-Site Number:8400051
  • Florida Institute for Clinical Research, LLC-Site Number:8400029
  • Emerald Coast Research Associates-Site Number:8400032
  • Sarasota Clinical Research-Site Number:8400026
  • VitaLink research-Hamilton Mill-Site Number:8400055
  • DC Research Works-Site Number:8400016
  • North Georgia Clinical Research-Site Number:8400025
  • Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012
  • Asthma Allergy & Sinus Center-Site Number:8400038
  • Michigan Medicine (University of Michigan)-Site Number:8400050
  • Mayo Clinic Lanmark Center 2-46-Site Number:8400065
  • University of Mississippi , Medical Center-Site Number:8400071
  • Midwest Chest Consultants, P.C.-Site Number:8400011
  • Washington University School of Medicine-Site Number:8400004
  • Sierra Clinical Research-Site Number:8400035
  • Va Western New York Healthcare-Site Number:8400067
  • IMA Clinical Research, LLC-Site Number:8400070
  • The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019
  • American Health Research-Site Number:8400061
  • Duke Asthma, Allergy and Airway Center-Site Number:8400064
  • Accellacare-Site Number:8400052
  • Southeastern Research Center-Site Number:8400060
  • Midwest Pulmonary and Sleep Research Center-Site Number:8400040
  • Aventiv Research, Inc-Site Number:8400024
  • OK Clinical Research-Site Number:8400005
  • Velocity Clinical Research, Medford-Site Number:8400001
  • Jefferson Associates in Internal Medicine-Site Number:8400037
  • Temple University Hospital-Site Number:8400009
  • Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033
  • Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063
  • VitaLink Research-Easley-Site Number:8400022
  • VitaLink Research- Gaffney-Site Number:8400047
  • VitaLink Research-Greenville-Site Number:8400007
  • Clinical Research of Charleston-Site Number:8400044
  • Clinical Research of Rock Hill-Site Number:8400046
  • VitaLink Research - Spartanburg-Site Number:8400048
  • Clinical Trials Center of Middle Tennessee-Site Number:8400073
  • University of Texas Medical Branch (UTMB)-Site Number:8400002
  • Bayer College of Medicine-Site Number:8400018
  • Metroplex Pulmonary and Sleep Center-Site Number:8400021
  • Sherman Clinical Research-Site Number:8400027
  • MultiCare Institute for Research and Innovation-Site Number:8400036
  • Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008
  • Investigational Site Number :0320011
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dupilumab

Placebo

Arm Description

Dupilumab administered every 2 weeks

Placebo dose administered every 2 weeks

Outcomes

Primary Outcome Measures

Annual rate of acute COPD exacerbation (AECOPD)
Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo

Secondary Outcome Measures

Change in pre-bronchodilator FEV1
Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo
Change in SGRQ
Change from baseline to Week 52 in SGRQ total score compared to placebo
Improvement in SGRQ
Proportion of patients with SGRQ improvement ≥4 points at Week 52
Change in pre-bronchodilator FEV1 from baseline to Week 52
Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo
Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44
Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 24, 36, and 44) compared to placebo
Change in post-bronchodilator FEV1 lung function
Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo
Change in forced expiratory flow (FEF) 25-75%
Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 24, 36, 44 and 52
Annualized rate of severe AECOPD
Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period
Time to first AECOPD
Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period
Adverse events
Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs)
Potentially clinically significant abnormality (PCSA) in laboratory tests
Percentage of patients with at least one incidence of PCSA
Anti-drug antibodies
Incidence of anti-drug antibodies against dupilumab

Full Information

First Posted
April 26, 2019
Last Updated
May 22, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03930732
Brief Title
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Acronym
BOREAS
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
February 8, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by Annualized rate of acute moderate and severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) Pre-bronchodilator FEV1 over 52 weeks compared to placebo Lung function assessments Moderate and severe COPD exacerbations To evaluate safety and tolerability To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)
Detailed Description
Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
939 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab
Arm Type
Experimental
Arm Description
Dupilumab administered every 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dose administered every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Dupilumab SAR231893
Other Intervention Name(s)
Dupixent
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Inhaled Corticosteroid
Intervention Description
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Intervention Type
Drug
Intervention Name(s)
Inhaled Long-Acting Beta Agonist
Intervention Description
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Intervention Type
Drug
Intervention Name(s)
Inhaled Long-Acting Muscarinic Antagonist
Intervention Description
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Annual rate of acute COPD exacerbation (AECOPD)
Description
Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo
Time Frame
Baseline to Week 52
Secondary Outcome Measure Information:
Title
Change in pre-bronchodilator FEV1
Description
Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo
Time Frame
Baseline to Week 12
Title
Change in SGRQ
Description
Change from baseline to Week 52 in SGRQ total score compared to placebo
Time Frame
Baseline to Week 52
Title
Improvement in SGRQ
Description
Proportion of patients with SGRQ improvement ≥4 points at Week 52
Time Frame
Baseline to Week 52
Title
Change in pre-bronchodilator FEV1 from baseline to Week 52
Description
Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo
Time Frame
Baseline to Week 52
Title
Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44
Description
Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 24, 36, and 44) compared to placebo
Time Frame
Baseline to Weeks 2, 4, 8, 24, 36, 44
Title
Change in post-bronchodilator FEV1 lung function
Description
Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, 52
Title
Change in forced expiratory flow (FEF) 25-75%
Description
Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 24, 36, 44 and 52
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, 44, 52
Title
Annualized rate of severe AECOPD
Description
Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period
Time Frame
Baseline through Week 52
Title
Time to first AECOPD
Description
Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period
Time Frame
Baseline through Week 52
Title
Adverse events
Description
Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs)
Time Frame
Baseline through Week 64
Title
Potentially clinically significant abnormality (PCSA) in laboratory tests
Description
Percentage of patients with at least one incidence of PCSA
Time Frame
Baseline through Week 64
Title
Anti-drug antibodies
Description
Incidence of anti-drug antibodies against dupilumab
Time Frame
Baseline to Week 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants with a physician diagnosis of COPD who meet the following criteria at screening: Current or former smokers with a smoking history of ≥10 pack-years. Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%). Medical Research Council (MRC) Dyspnea Scale grade ≥2. Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough. Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations are recorded by the investigator and defined as acute exacerbation of COPD (AECOPD) that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization or observation >24 hours in emergency department/urgent care facility. Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated. Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1. Exclusion criteria: COPD diagnosis for less than 12 months prior to randomization. A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines. Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. Cor pulmonale, evidence of right cardiac failure. Treatment with oxygen of more than 12 hours per day. Hypercapnia requiring Bi-level ventilation. AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period. Respiratory tract infection within 4 weeks prior to screening, or during the screening period. History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included). Diagnosis of α-1 anti-trypsin deficiency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
SEC Clinical Research, LLC-Site Number:8400030
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
Country
United States
Facility Name
Clinical Research Center of Alabama, LLC-Site Number:8400041
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209-6802
Country
United States
Facility Name
UAB Lung Health Center-Site Number:8400013
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
SEC Clinical Research, LLC-Site Number:8400059
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Pulmonary Associates of Mobile, P.C.-Site Number:8400057
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Asthma and Allergy Associates, PC-Site Number:8400034
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Clinical Research Of West Florida Inc-Site Number:8400010
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Finlay Medical Research-Site Number:8400014
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Project 4 research, Inc.-Site Number:8400023
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Finlay Medical Research-Site Number:8400062
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Reed Medical Research-Site Number:8400079
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Renstar Medical Research-Site Number:8400051
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Florida Institute for Clinical Research, LLC-Site Number:8400029
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Emerald Coast Research Associates-Site Number:8400032
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Sarasota Clinical Research-Site Number:8400026
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
VitaLink research-Hamilton Mill-Site Number:8400055
City
Dacula
State/Province
Georgia
ZIP/Postal Code
30019
Country
United States
Facility Name
DC Research Works-Site Number:8400016
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Georgia Clinical Research-Site Number:8400025
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Asthma Allergy & Sinus Center-Site Number:8400038
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Michigan Medicine (University of Michigan)-Site Number:8400050
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Lanmark Center 2-46-Site Number:8400065
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi , Medical Center-Site Number:8400071
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Midwest Chest Consultants, P.C.-Site Number:8400011
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Washington University School of Medicine-Site Number:8400004
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Sierra Clinical Research-Site Number:8400035
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Va Western New York Healthcare-Site Number:8400067
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
IMA Clinical Research, LLC-Site Number:8400070
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
American Health Research-Site Number:8400061
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Duke Asthma, Allergy and Airway Center-Site Number:8400064
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Accellacare-Site Number:8400052
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Southeastern Research Center-Site Number:8400060
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4027
Country
United States
Facility Name
Midwest Pulmonary and Sleep Research Center-Site Number:8400040
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Aventiv Research, Inc-Site Number:8400024
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
OK Clinical Research-Site Number:8400005
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Velocity Clinical Research, Medford-Site Number:8400001
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Jefferson Associates in Internal Medicine-Site Number:8400037
City
Clairton
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
Temple University Hospital-Site Number:8400009
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
VitaLink Research-Easley-Site Number:8400022
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
VitaLink Research- Gaffney-Site Number:8400047
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
VitaLink Research-Greenville-Site Number:8400007
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Clinical Research of Charleston-Site Number:8400044
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Research of Rock Hill-Site Number:8400046
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
VitaLink Research - Spartanburg-Site Number:8400048
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Clinical Trials Center of Middle Tennessee-Site Number:8400073
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
University of Texas Medical Branch (UTMB)-Site Number:8400002
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Bayer College of Medicine-Site Number:8400018
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Metroplex Pulmonary and Sleep Center-Site Number:8400021
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Sherman Clinical Research-Site Number:8400027
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
MultiCare Institute for Research and Innovation-Site Number:8400036
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Investigational Site Number :0320011
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Investigational Site Number :0320002
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Investigational Site Number :0320003
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Investigational Site Number :0320004
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425FVH
Country
Argentina
Facility Name
Investigational Site Number :0320012
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900BNN
Country
Argentina
Facility Name
Investigational Site Number :0320007
City
Quilmes
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
B1878FNR
Country
Argentina
Facility Name
Investigational Site Number :0320006
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Investigational Site Number :0320009
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
Investigational Site Number :0320001
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Investigational Site Number :0320005
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site Number :0320008
City
Mar Del Plata
ZIP/Postal Code
B7600
Country
Argentina
Facility Name
Investigational Site Number :0320010
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Investigational Site Number :1001004
City
Haskovo
ZIP/Postal Code
6305
Country
Bulgaria
Facility Name
Investigational Site Number :1001003
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Investigational Site Number :1001006
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Investigational Site Number :1001009
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Investigational Site Number :1001002
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Investigational Site Number :1001001
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
Investigational Site Number :1001005
City
Stara Zagora
ZIP/Postal Code
6001
Country
Bulgaria
Facility Name
Investigational Site Number :1001010
City
Troyan
ZIP/Postal Code
5600
Country
Bulgaria
Facility Name
Investigational Site Number :1240021
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H4B9
Country
Canada
Facility Name
Investigational Site Number :1240015
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Investigational Site Number :1240016
City
Sherwood Park
State/Province
Alberta
ZIP/Postal Code
T8H 0N2
Country
Canada
Facility Name
Investigational Site Number :1240017
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Investigational Site Number :1240007
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Investigational Site Number :1240002
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Investigational Site Number :1240012
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Investigational Site Number :1240013
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Investigational Site Number :1240009
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Investigational Site Number :1240003
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Investigational Site Number :1240001
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Investigational Site Number :1240010
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number :1240011
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Investigational Site Number :1240006
City
St-charles Borrommee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
Investigational Site Number :1240008
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Investigational Site Number :1240020
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Investigational Site Number :1240005
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Investigational Site Number :1240004
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Investigational Site Number :1240019
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Investigational Site Number :1240018
City
Quebec
ZIP/Postal Code
GIS 2L6
Country
Canada
Facility Name
Investigational Site Number :1520006
City
Curicó
State/Province
Maule
ZIP/Postal Code
3341643
Country
Chile
Facility Name
Investigational Site Number :1520001
City
Talca
State/Province
Maule
Country
Chile
Facility Name
Investigational Site Number :1520009
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500587
Country
Chile
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500692
Country
Chile
Facility Name
Investigational Site Number :1520005
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500698
Country
Chile
Facility Name
Investigational Site Number :1520008
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8380453
Country
Chile
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8910131
Country
Chile
Facility Name
Investigational Site Number :1520004
City
Quillota
State/Province
Valparaíso
ZIP/Postal Code
2260877
Country
Chile
Facility Name
Investigational Site Number :1560037
City
Baotou
ZIP/Postal Code
014010
Country
China
Facility Name
Investigational Site Number :1560006
City
Beijing
Country
China
Facility Name
Investigational Site Number :1560003
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number :1560022
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Investigational Site Number :1560021
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Investigational Site Number :1560001
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Investigational Site Number :1560017
City
Chengdu
ZIP/Postal Code
611130
Country
China
Facility Name
Investigational Site Number :1560012
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Investigational Site Number :1560005
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Investigational Site Number :1560053
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Investigational Site Number :1560036
City
Guangzhou
ZIP/Postal Code
510150
Country
China
Facility Name
Investigational Site Number :1560019
City
Guangzhou
ZIP/Postal Code
510163
Country
China
Facility Name
Investigational Site Number :1560045
City
Haikou
ZIP/Postal Code
570216
Country
China
Facility Name
Investigational Site Number :1560018
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Investigational Site Number :1560046
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Investigational Site Number :1560009
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
Investigational Site Number :1560041
City
Hefei
Country
China
Facility Name
Investigational Site Number :1560015
City
Hohhot
ZIP/Postal Code
010017
Country
China
Facility Name
Investigational Site Number :1560008
City
Hohhot
ZIP/Postal Code
010050
Country
China
Facility Name
Investigational Site Number :1560027
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Investigational Site Number :1560034
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Investigational Site Number :1560032
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Investigational Site Number :1560013
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Investigational Site Number :1560007
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Investigational Site Number :1560014
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Investigational Site Number :1560004
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Investigational Site Number :1560051
City
Shenzhen
ZIP/Postal Code
518020
Country
China
Facility Name
Investigational Site Number :1560016
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Investigational Site Number :1560024
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Investigational Site Number :1560010
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Investigational Site Number :1560028
City
Urumchi
ZIP/Postal Code
830054
Country
China
Facility Name
Investigational Site Number :1560052
City
Wuhan
ZIP/Postal Code
430014
Country
China
Facility Name
Investigational Site Number :1560020
City
Xi'An
ZIP/Postal Code
710061
Country
China
Facility Name
Investigational Site Number :1560054
City
Xuzhou
ZIP/Postal Code
221002
Country
China
Facility Name
Investigational Site Number :1560011
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Facility Name
Investigational Site Number :1560047
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Facility Name
Investigational Site Number :1560031
City
Zhanjiang
ZIP/Postal Code
524001
Country
China
Facility Name
Investigational Site Number :1560002
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
Investigational Site Number :2030002
City
Jindrichuv Hradec III
ZIP/Postal Code
37701
Country
Czechia
Facility Name
Investigational Site Number :2030005
City
Karlovy Vary
ZIP/Postal Code
36017
Country
Czechia
Facility Name
Investigational Site Number :2030009
City
Miroslav
ZIP/Postal Code
67172
Country
Czechia
Facility Name
Investigational Site Number :2030001
City
Novy Bor
ZIP/Postal Code
47301
Country
Czechia
Facility Name
Investigational Site Number :2030003
City
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Investigational Site Number :2030008
City
Praha 6 - Brevnov
ZIP/Postal Code
16900
Country
Czechia
Facility Name
Investigational Site Number :2030004
City
Rokycany
ZIP/Postal Code
33722
Country
Czechia
Facility Name
Investigational Site Number :2030006
City
Strakonice
ZIP/Postal Code
38601
Country
Czechia
Facility Name
Investigational Site Number :2080001
City
Copenhagen Nv
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Investigational Site Number :2080002
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Investigational Site Number :2080006
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Investigational Site Number :2080005
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site Number :2080004
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Investigational Site Number :2080007
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Investigational Site Number :2080003
City
Ålborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Investigational Site Number :2460003
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Investigational Site Number :2460002
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Investigational Site Number :2460001
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Investigational Site Number :2760006
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Investigational Site Number :2760009
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Investigational Site Number :2760002
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Investigational Site Number :2760007
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Investigational Site Number :2760011
City
Leipzig
ZIP/Postal Code
04347
Country
Germany
Facility Name
Investigational Site Number :2760010
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Investigational Site Number :2760008
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Investigational Site Number :3480007
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Investigational Site Number :3480011
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Investigational Site Number :3480008
City
Edelény
ZIP/Postal Code
3780
Country
Hungary
Facility Name
Investigational Site Number :3480001
City
Gödöllö
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Investigational Site Number :3480010
City
Hajdunánás
ZIP/Postal Code
4080
Country
Hungary
Facility Name
Investigational Site Number :3480002
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Investigational Site Number :3480003
City
Makó
ZIP/Postal Code
6900
Country
Hungary
Facility Name
Investigational Site Number :3480006
City
Mohács
ZIP/Postal Code
7700
Country
Hungary
Facility Name
Investigational Site Number :3480012
City
Puspokladany
ZIP/Postal Code
4150
Country
Hungary
Facility Name
Investigational Site Number :3480005
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Investigational Site Number :3480004
City
Százhalombatta
ZIP/Postal Code
2440
Country
Hungary
Facility Name
Investigational Site Number :3760006
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Investigational Site Number :3760007
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Investigational Site Number :3760003
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Investigational Site Number :3760005
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Investigational Site Number :3760004
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Investigational Site Number :3760001
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Investigational Site Number :3760002
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Investigational Site Number :3800004
City
Cona
State/Province
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Investigational Site Number :3800003
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Investigational Site Number :3800006
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Investigational Site Number :3800002
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Investigational Site Number :3800007
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Investigational Site Number :3800001
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Investigational Site Number :3800005
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Investigational Site Number :3920013
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0813
Country
Japan
Facility Name
Investigational Site Number :3920011
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-0849
Country
Japan
Facility Name
Investigational Site Number :3920023
City
Higashiibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Investigational Site Number :3920014
City
Naka-gun
State/Province
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Investigational Site Number :3920019
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
761-8073
Country
Japan
Facility Name
Investigational Site Number :3920027
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
223-0059
Country
Japan
Facility Name
Investigational Site Number :3920003
City
Joyo-shi
State/Province
Kyoto
ZIP/Postal Code
610-0113
Country
Japan
Facility Name
Investigational Site Number :3920017
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Investigational Site Number :3920006
City
Ueda-shi
State/Province
Nagano
Country
Japan
Facility Name
Investigational Site Number :3920029
City
Urasoe-shi
State/Province
Okinawa
ZIP/Postal Code
901-2121
Country
Japan
Facility Name
Investigational Site Number :3920018
City
Kawachinagano-shi
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Investigational Site Number :3920001
City
Kishiwada-shi
State/Province
Osaka
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Investigational Site Number :3920028
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
531-0073
Country
Japan
Facility Name
Investigational Site Number :3920012
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Investigational Site Number :3920021
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
434-8511
Country
Japan
Facility Name
Investigational Site Number :3920008
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0022
Country
Japan
Facility Name
Investigational Site Number :3920030
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Investigational Site Number :3920005
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Investigational Site Number :3920015
City
Kokubunji-shi
State/Province
Tokyo
ZIP/Postal Code
185-0014
Country
Japan
Facility Name
Investigational Site Number :3920016
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
Investigational Site Number :3920004
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
170-0003
Country
Japan
Facility Name
Investigational Site Number :3920026
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
1710014
Country
Japan
Facility Name
Investigational Site Number :4100003
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100004
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100008
City
Incheon
State/Province
Incheon-gwangyeoksi
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100001
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100009
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Investigational Site Number :4100007
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Investigational Site Number :4840002
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Investigational Site Number :4840001
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number :4840004
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Investigational Site Number :4840003
City
Durango
ZIP/Postal Code
34080
Country
Mexico
Facility Name
Investigational Site Number :4840006
City
Mexico Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Investigational Site Number :4840007
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Investigational Site Number :4840005
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Investigational Site Number :6160009
City
Grudziadz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Investigational Site Number :6160007
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Investigational Site Number :6160015
City
Grodzisk Mazowiecki
State/Province
Mazowieckie
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Investigational Site Number :6160012
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-456
Country
Poland
Facility Name
Investigational Site Number :6160008
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Investigational Site Number :6160014
City
Elblag
State/Province
Pomorskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Investigational Site Number :6160011
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Investigational Site Number :6160016
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Investigational Site Number :6160006
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-578
Country
Poland
Facility Name
Investigational Site Number :6420001
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Investigational Site Number :6420009
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
Investigational Site Number :6420008
City
Bucuresti
ZIP/Postal Code
050159
Country
Romania
Facility Name
Investigational Site Number :6420003
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Investigational Site Number :6420004
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Investigational Site Number :6420007
City
Constanta
ZIP/Postal Code
900002
Country
Romania
Facility Name
Investigational Site Number :6420006
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Investigational Site Number :6420010
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Investigational Site Number :6430003
City
Chelyabinsk
ZIP/Postal Code
454091
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
Kazan
ZIP/Postal Code
420008
Country
Russian Federation
Facility Name
Investigational Site Number :6430006
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Investigational Site Number :6430008
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
117546
Country
Russian Federation
Facility Name
Investigational Site Number :6430009
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Investigational Site Number :6430007
City
St-Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Facility Name
Investigational Site Number :7030007
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Investigational Site Number :7030006
City
Humenne
ZIP/Postal Code
066 01
Country
Slovakia
Facility Name
Investigational Site Number :7030003
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Facility Name
Investigational Site Number :7030001
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Investigational Site Number :7030002
City
Spisska Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Facility Name
Investigational Site Number :7240096
City
Santiago de Compostela
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15706
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240007
City
Sant Boi de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08830
Country
Spain
Facility Name
Investigational Site Number :7240005
City
Mérida / Badajoz
State/Province
Extremadura
ZIP/Postal Code
06800
Country
Spain
Facility Name
Investigational Site Number :7240006
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number :7240010
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Investigational Site Number :7240004
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Investigational Site Number :7520001
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Investigational Site Number :7520002
City
Stockholm
ZIP/Postal Code
114 46
Country
Sweden
Facility Name
Investigational Site Number :7520003
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Investigational Site Number :7920004
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Investigational Site Number :7920001
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Investigational Site Number :7920006
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Investigational Site Number :7920007
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Investigational Site Number :7920008
City
Kirikkale
ZIP/Postal Code
71450
Country
Turkey
Facility Name
Investigational Site Number :7920005
City
Manisa
ZIP/Postal Code
45000
Country
Turkey
Facility Name
Investigational Site Number :7920002
City
Mersin
ZIP/Postal Code
33070
Country
Turkey
Facility Name
Investigational Site Number :8040003
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Investigational Site Number :8040001
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site Number :8040006
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Facility Name
Investigational Site Number :8040004
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Investigational Site Number :8040009
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
Investigational Site Number :8040005
City
Vinnytsya
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Investigational Site Number :8040007
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

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