Back to resultsPivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation (NOTUS)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Active
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
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion 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 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:
Exclusion criteria:
- COPD diagnosis for less than 12 months prior to randomization.
- Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.
- 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.
- Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88%
- 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
- Cullman Research Center, LLC-Site Number:8400095
- Pulmonary & Sleep Associates of Jasper PC-Site Number:8400090
- Scottsboro Quick Care Clinic-Site Number:8400116
- Phoenix Medical Group-Site Number:8400061
- Medical Advancement Center of Arizona-Site Number:8400107
- Asthma and Allergy Institute-Site Number:8400022
- Kern Research, Inc-Site Number:8400031
- NewportNativeMD, Inc-Site Number:8400032
- Prospective Research Innovations, Inc.-Site Number:8400063
- ACRC Studies-Site Number:8400094
- Institute of HealthCare Assessment, Inc.-Site Number:8400015
- Allianz Research Institute-Site Number:8400007
- Innovative Clinical Research-Site Number:8400018
- Central Florida Pulmonary Group, PA-Site Number:8400102
- Helix Biomedics, LLC-Site Number:8400035
- Pioneer Clinical Research-Site Number:8400043
- Synergy Healthcare-Site Number:8400111
- Renaissance Research and Medical Group, Inc-Site Number:8400092
- St. Francis Sleep, Allergy and Lung Institute-Site Number:8400020
- Beautiful Minds Clinical Research Center-Site Number:8400081
- Omega Research Consultants, LLC-Site Number:8400021
- Sciences Connections, LLC-Site Number:8400133
- InvesClinic, LLC-Site Number:8400039
- Vanguard Clinical Research-Site Number:8400047
- Finlay Medical Research-Site Number:8400071
- Direct Helpers Medical Center Inc-Site Number:8400079
- DL Research Solutions Inc-Site Number:8400089
- Phoenix Medical Research, LLC-Site Number:8400012
- Columbus Clinical Services-Site Number:8400062
- Reed Medical Research-Site Number:8400123
- De La Cruz Research Center, LLC-Site Number:8400075
- Florida Institute for Clinical Research-Site Number:8400129
- Central Florida Pulmonary Group, PA-Site Number:8400101
- Innovation Medical Research Center-Site Number:8400114
- Family Medical Specialists of Florida, PA-Site Number:8400077
- Coastal Pulmonary And Critical Care-Site Number:8400013
- Florida Pulmonary Research Center-Site Number:8400001
- Appalachian Clinical Research-Site Number:8400048
- Northlake Medical Group-Site Number:8400099
- River Birch Research, LLC-Site Number:8400045
- Medical Centre of Conyers-Site Number:8400064
- David Kavtaradze MD, Inc.-Site Number:8400135
- Gwinnett Biomedical Research-Site Number:8400052
- Southeast Lung Associates-Site Number:8400003
- Herman Clinical Research LLC-Site Number:8400078
- Qualmedica Research, LLC-Site Number:8400119
- Avant Research Associates LLC-Site Number:8400118
- Genesis Clinical Research & Consulting-Site Number:8400050
- Infinity Medical Research-Site Number:8400004
- Henry Ford Health System-Site Number:8400053
- Revive Research Institute-Site Number:8400120
- Romedica, LLC-Site Number:8400034
- Covenant Healthcare-Site Number:8400057
- Great Lakes Research Institute-Site Number:8400096
- Montana Medical Research-Site Number:8400019
- Somnos Clinical Research-Site Number:8400016
- Quality Clinical Research, Inc.-Site Number:8400073
- Jersey City Breathing Center-Site Number:8400137
- WellNow Urgent Care-Site Number:8400132
- Northwell Health-Site Number:8400054
- Mid Hudson Medical Research PLLC-Site Number:8400037
- Great Lakes Medical Research-Site Number:8400044
- Onsite Clinical Solutions LLC-Site Number:8400042
- LLM Research-Site Number:8400125
- Clinical Research of Gastonia-Site Number:8400010
- Monroe Biomedical Research-Site Number:8400087
- Lake Norman Pulmonary and Sleep Medicine - Mooresville-Site Number:8400006
- Lapis Clinical Research At BlueSkies Family Medicine-Site Number:8400117
- Coastal Carolina Health Care, P.A.-Site Number:8400025
- Southeastern Research Center-Site Number:8400068
- Optimed Research, LTD-Site Number:8400082
- Toledo Institute of Clinical Research-Site Number:8400024
- Allergy, Asthma and Clinical Research Center-Site Number:8400127
- Clinical Research of Central PA-Site Number:8400009
- Frontier Clinical Research, LLC-Site Number:8400049
- Carolina Medical Research, LLC-Site Number:8400026
- MD First Research-Site Number:8400105
- Clinical Research of Rock Hill-Site Number:8400138
- Health Concepts-Site Number:8400027
- Pulmonary & Sleep Specialists-Site Number:8400136
- Clinical Trials Center of Middle Tennessee-Site Number:8400066
- MultiSpecialty Clinical Research-Site Number:8400110
- REX Clinical Trials-Site Number:8400143
- Clinrx Research-Site Number:8400059
- Houston Pulmonary and Sleep Associates-Site Number:8400011
- Biopharma Informatic - Cardiff Avenue - PPDS-Site Number:8400055
- Prolato Clinical Research Center-Site Number:8400128
- Pioneer Research Solutions, Inc.-Site Number:8400070
- Vytalus Medical Group-Site Number:8400139
- FMC Science, LLC-Site Number:8400029
- DCOL Center for Clinical Research-Site Number:8400028
- Metroplex Pulmonary and Sleep Center-Site Number:8400131
- Clinrx Research, LLC-Site Number:8400069
- Diagnostics Research Group-Site Number:8400038
- Pulmonary & Sleep Institute, PA - San Antonio-Site Number:8400080
- Mt. Olympus Medical Research-Site Number:8400115
- Pulmonary Research of Abingdon, LLC-Site Number:8400030
- Clinical Research Partners-Site Number:8400040
- Allergy, Asthma & Sinus Center, S.C.-Site Number:8400088
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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
NCT ID
NCT04456673
First Posted
June 30, 2020
Last Updated
June 2, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04456673
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
NOTUS
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
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
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 or 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 antidrug 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
935 (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 through week 64
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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:
Exclusion criteria:
COPD diagnosis for less than 12 months prior to randomization.
Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.
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.
Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88%
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
Cullman Research Center, LLC-Site Number:8400095
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
Pulmonary & Sleep Associates of Jasper PC-Site Number:8400090
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Scottsboro Quick Care Clinic-Site Number:8400116
City
Scottsboro
State/Province
Alabama
ZIP/Postal Code
35768
Country
United States
Facility Name
Phoenix Medical Group-Site Number:8400061
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Medical Advancement Center of Arizona-Site Number:8400107
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Asthma and Allergy Institute-Site Number:8400022
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Kern Research, Inc-Site Number:8400031
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
NewportNativeMD, Inc-Site Number:8400032
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Prospective Research Innovations, Inc.-Site Number:8400063
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
ACRC Studies-Site Number:8400094
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Institute of HealthCare Assessment, Inc.-Site Number:8400015
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Allianz Research Institute-Site Number:8400007
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Innovative Clinical Research-Site Number:8400018
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Central Florida Pulmonary Group, PA-Site Number:8400102
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Helix Biomedics, LLC-Site Number:8400035
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Pioneer Clinical Research-Site Number:8400043
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Synergy Healthcare-Site Number:8400111
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Renaissance Research and Medical Group, Inc-Site Number:8400092
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33991
Country
United States
Facility Name
St. Francis Sleep, Allergy and Lung Institute-Site Number:8400020
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Beautiful Minds Clinical Research Center-Site Number:8400081
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Omega Research Consultants, LLC-Site Number:8400021
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Sciences Connections, LLC-Site Number:8400133
City
Doral
State/Province
Florida
ZIP/Postal Code
33178
Country
United States
Facility Name
InvesClinic, LLC-Site Number:8400039
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Vanguard Clinical Research-Site Number:8400047
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Finlay Medical Research-Site Number:8400071
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
Direct Helpers Medical Center Inc-Site Number:8400079
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
DL Research Solutions Inc-Site Number:8400089
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Phoenix Medical Research, LLC-Site Number:8400012
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Columbus Clinical Services-Site Number:8400062
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Reed Medical Research-Site Number:8400123
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
De La Cruz Research Center, LLC-Site Number:8400075
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
Florida Institute for Clinical Research-Site Number:8400129
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825-4454
Country
United States
Facility Name
Central Florida Pulmonary Group, PA-Site Number:8400101
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Innovation Medical Research Center-Site Number:8400114
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Family Medical Specialists of Florida, PA-Site Number:8400077
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
Facility Name
Coastal Pulmonary And Critical Care-Site Number:8400013
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33704
Country
United States
Facility Name
Florida Pulmonary Research Center-Site Number:8400001
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Appalachian Clinical Research-Site Number:8400048
City
Adairsville
State/Province
Georgia
ZIP/Postal Code
30103
Country
United States
Facility Name
Northlake Medical Group-Site Number:8400099
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
River Birch Research, LLC-Site Number:8400045
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Medical Centre of Conyers-Site Number:8400064
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
David Kavtaradze MD, Inc.-Site Number:8400135
City
Cordele
State/Province
Georgia
ZIP/Postal Code
31015
Country
United States
Facility Name
Gwinnett Biomedical Research-Site Number:8400052
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Southeast Lung Associates-Site Number:8400003
City
Rincon
State/Province
Georgia
ZIP/Postal Code
31326
Country
United States
Facility Name
Herman Clinical Research LLC-Site Number:8400078
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Qualmedica Research, LLC-Site Number:8400119
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Avant Research Associates LLC-Site Number:8400118
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Genesis Clinical Research & Consulting-Site Number:8400050
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02723
Country
United States
Facility Name
Infinity Medical Research-Site Number:8400004
City
South Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Henry Ford Health System-Site Number:8400053
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Revive Research Institute-Site Number:8400120
City
Lathrup Village
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Romedica, LLC-Site Number:8400034
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Covenant Healthcare-Site Number:8400057
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48638
Country
United States
Facility Name
Great Lakes Research Institute-Site Number:8400096
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Montana Medical Research-Site Number:8400019
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Somnos Clinical Research-Site Number:8400016
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Quality Clinical Research, Inc.-Site Number:8400073
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Jersey City Breathing Center-Site Number:8400137
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07304
Country
United States
Facility Name
WellNow Urgent Care-Site Number:8400132
City
E. Amherst
State/Province
New York
ZIP/Postal Code
14051
Country
United States
Facility Name
Northwell Health-Site Number:8400054
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Mid Hudson Medical Research PLLC-Site Number:8400037
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553-7754
Country
United States
Facility Name
Great Lakes Medical Research-Site Number:8400044
City
Westfield
State/Province
New York
ZIP/Postal Code
14787
Country
United States
Facility Name
Onsite Clinical Solutions LLC-Site Number:8400042
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
LLM Research-Site Number:8400125
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
29577
Country
United States
Facility Name
Clinical Research of Gastonia-Site Number:8400010
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Monroe Biomedical Research-Site Number:8400087
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Lake Norman Pulmonary and Sleep Medicine - Mooresville-Site Number:8400006
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Lapis Clinical Research At BlueSkies Family Medicine-Site Number:8400117
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Coastal Carolina Health Care, P.A.-Site Number:8400025
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Southeastern Research Center-Site Number:8400068
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Optimed Research, LTD-Site Number:8400082
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Toledo Institute of Clinical Research-Site Number:8400024
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Allergy, Asthma and Clinical Research Center-Site Number:8400127
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Clinical Research of Central PA-Site Number:8400009
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Facility Name
Frontier Clinical Research, LLC-Site Number:8400049
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Facility Name
Carolina Medical Research, LLC-Site Number:8400026
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
Facility Name
MD First Research-Site Number:8400105
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Facility Name
Clinical Research of Rock Hill-Site Number:8400138
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Health Concepts-Site Number:8400027
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Pulmonary & Sleep Specialists-Site Number:8400136
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Clinical Trials Center of Middle Tennessee-Site Number:8400066
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
MultiSpecialty Clinical Research-Site Number:8400110
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
REX Clinical Trials-Site Number:8400143
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701-3713
Country
United States
Facility Name
Clinrx Research-Site Number:8400059
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Houston Pulmonary and Sleep Associates-Site Number:8400011
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Biopharma Informatic - Cardiff Avenue - PPDS-Site Number:8400055
City
Houston
State/Province
Texas
ZIP/Postal Code
77043-2742
Country
United States
Facility Name
Prolato Clinical Research Center-Site Number:8400128
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Pioneer Research Solutions, Inc.-Site Number:8400070
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Vytalus Medical Group-Site Number:8400139
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
FMC Science, LLC-Site Number:8400029
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550-1820
Country
United States
Facility Name
DCOL Center for Clinical Research-Site Number:8400028
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Metroplex Pulmonary and Sleep Center-Site Number:8400131
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Clinrx Research, LLC-Site Number:8400069
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Diagnostics Research Group-Site Number:8400038
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pulmonary & Sleep Institute, PA - San Antonio-Site Number:8400080
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Mt. Olympus Medical Research-Site Number:8400115
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Pulmonary Research of Abingdon, LLC-Site Number:8400030
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Clinical Research Partners-Site Number:8400040
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Facility Name
Allergy, Asthma & Sinus Center, S.C.-Site Number:8400088
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Investigational Site Number :0320007
City
Berazategui
State/Province
Buenos Aires
ZIP/Postal Code
CP 1884
Country
Argentina
Facility Name
Investigational Site Number :0320006
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Facility Name
Investigational Site Number :0320004
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Investigational Site Number :0320003
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425FVH
Country
Argentina
Facility Name
Investigational Site Number :0320010
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900BNN
Country
Argentina
Facility Name
Investigational Site Number :0320013
City
Lobos
State/Province
Buenos Aires
ZIP/Postal Code
7240
Country
Argentina
Facility Name
Investigational Site Number :0320005
City
Quilmes
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
B1878FNR
Country
Argentina
Facility Name
Investigational Site Number :0320011
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Investigational Site Number :0320008
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DEJ
Country
Argentina
Facility Name
Investigational Site Number :0320009
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002OJP
Country
Argentina
Facility Name
Investigational Site Number :0320002
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Investigational Site Number :0320012
City
Launs Este
ZIP/Postal Code
B1824KAJ
Country
Argentina
Facility Name
Investigational Site Number :0360003
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Investigational Site Number :0360008
City
Kent Town
State/Province
South Australia
ZIP/Postal Code
5067
Country
Australia
Facility Name
Investigational Site Number :0360006
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Investigational Site Number :0360005
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Investigational Site Number :0360001
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Investigational Site Number :0560002
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Investigational Site Number :0560001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number :0560003
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Investigational Site Number :0560004
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Investigational Site Number :0760019
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150-150
Country
Brazil
Facility Name
Investigational Site Number :0760020
City
Vitoria
State/Province
Espírito Santo
ZIP/Postal Code
29055 450
Country
Brazil
Facility Name
Investigational Site Number :0760011
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Investigational Site Number :0760008
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-120
Country
Brazil
Facility Name
Investigational Site Number :0760017
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Investigational Site Number :0760001
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90160-090
Country
Brazil
Facility Name
Investigational Site Number :0760006
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89030-100
Country
Brazil
Facility Name
Investigational Site Number :0760018
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88040-970
Country
Brazil
Facility Name
Investigational Site Number :0760015
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13059900
Country
Brazil
Facility Name
Investigational Site Number :0760007
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Investigational Site Number :0760003
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Investigational Site Number :0760012
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01229-010
Country
Brazil
Facility Name
Investigational Site Number :0760021
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Investigational Site Number :0760002
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Investigational Site Number :0760009
City
Sorocaba
State/Province
São Paulo
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Investigational Site Number :1005025
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Investigational Site Number :1005021
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Investigational Site Number :1005012
City
Haskovo
ZIP/Postal Code
6305
Country
Bulgaria
Facility Name
Investigational Site Number :1005011
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Investigational Site Number :1005008
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Investigational Site Number :1005015
City
Ruse
ZIP/Postal Code
70000
Country
Bulgaria
Facility Name
Investigational Site Number :1005013
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Investigational Site Number :1005018
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Investigational Site Number :1005003
City
Sofia
ZIP/Postal Code
1142
Country
Bulgaria
Facility Name
Investigational Site Number :1005001
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Investigational Site Number :1005006
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Investigational Site Number :1005002
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Investigational Site Number :1005026
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Investigational Site Number :1005024
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Investigational Site Number :1005004
City
Stara Zagora
ZIP/Postal Code
6001
Country
Bulgaria
Facility Name
Investigational Site Number :1005023
City
Veliko Tyrnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Investigational Site Number :1005027
City
Veliko Tyrnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Investigational Site Number :1005019
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
Investigational Site Number :1005020
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Investigational Site Number :1240015
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3L 3E6
Country
Canada
Facility Name
Investigational Site Number :1240018
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 5T1
Country
Canada
Facility Name
Investigational Site Number :1240017
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
Investigational Site Number :1240014
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 5C4
Country
Canada
Facility Name
Investigational Site Number :1240010
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
Investigational Site Number :1240009
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Investigational Site Number :1240007
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Investigational Site Number :1240004
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Investigational Site Number :1240012
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Investigational Site Number :1240001
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Facility Name
Investigational Site Number :1240005
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
Investigational Site Number :1520009
City
Valdivia
State/Province
Los Ríos
ZIP/Postal Code
5110683
Country
Chile
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 :1520007
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500571
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 :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 :1700002
City
Bogota
ZIP/Postal Code
11001000
Country
Colombia
Facility Name
Investigational Site Number :1700007
City
Bucaramanga
Country
Colombia
Facility Name
Investigational Site Number :1700005
City
Manizales
ZIP/Postal Code
170004
Country
Colombia
Facility Name
Investigational Site Number :2030009
City
Havlickuv Brod
ZIP/Postal Code
580 01
Country
Czechia
Facility Name
Investigational Site Number :2030004
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Investigational Site Number :2030001
City
Jindrichuv Hradec III
ZIP/Postal Code
37701
Country
Czechia
Facility Name
Investigational Site Number :2030007
City
Kralupy nad Vltavou
ZIP/Postal Code
278 01
Country
Czechia
Facility Name
Investigational Site Number :2030003
City
Miroslav
ZIP/Postal Code
67172
Country
Czechia
Facility Name
Investigational Site Number :2030010
City
Nymburk
ZIP/Postal Code
288 01
Country
Czechia
Facility Name
Investigational Site Number :2030002
City
Strakonice
ZIP/Postal Code
38601
Country
Czechia
Facility Name
Investigational Site Number :2030008
City
Trutnov
ZIP/Postal Code
541 01
Country
Czechia
Facility Name
Investigational Site Number :2500009
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Investigational Site Number :2500010
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Investigational Site Number :2500002
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Investigational Site Number :2500005
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Investigational Site Number :2500013
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Investigational Site Number :2500004
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Investigational Site Number :2500003
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number :2500001
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :2500007
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Investigational Site Number :2500008
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Investigational Site Number :2500006
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Investigational Site Number :2760024
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Investigational Site Number :2760025
City
Berlin
ZIP/Postal Code
12159
Country
Germany
Facility Name
Investigational Site Number :2760017
City
Darmstadt
ZIP/Postal Code
64283
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 :2760003
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Investigational Site Number :2760007
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Investigational Site Number :2760023
City
Leipzig
ZIP/Postal Code
04299
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 :2760012
City
Mainz
ZIP/Postal Code
55128
Country
Germany
Facility Name
Investigational Site Number :2760008
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Investigational Site Number :2760020
City
Peine
ZIP/Postal Code
31224
Country
Germany
Facility Name
Investigational Site Number :2760016
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Investigational Site Number :2760018
City
Wiesbaden
ZIP/Postal Code
65183
Country
Germany
Facility Name
Investigational Site Number :3000001
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Investigational Site Number :3000005
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Investigational Site Number :3000006
City
Athens
Country
Greece
Facility Name
Investigational Site Number :3000003
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Investigational Site Number :3000002
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
Investigational Site Number :3000007
City
Palaio Faliro, Athens
ZIP/Postal Code
17562
Country
Greece
Facility Name
Investigational Site Number :3000004
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Investigational Site Number :3480003
City
Edelény
ZIP/Postal Code
3780
Country
Hungary
Facility Name
Investigational Site Number :3480004
City
Gödöllö
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Investigational Site Number :3480002
City
Hajdunánás
ZIP/Postal Code
4080
Country
Hungary
Facility Name
Investigational Site Number :3480006
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Investigational Site Number :3480005
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Investigational Site Number :3480001
City
Százhalombatta
ZIP/Postal Code
2440
Country
Hungary
Facility Name
Investigational Site Number :4280008
City
Balvi
ZIP/Postal Code
LV-4501
Country
Latvia
Facility Name
Investigational Site Number :4280007
City
Rezekne
ZIP/Postal Code
LV - 4601
Country
Latvia
Facility Name
Investigational Site Number :4280001
City
Riga
ZIP/Postal Code
LV -1010
Country
Latvia
Facility Name
Investigational Site Number :4280005
City
Riga
ZIP/Postal Code
LV -1010
Country
Latvia
Facility Name
Investigational Site Number :4280006
City
Riga
ZIP/Postal Code
LV -1021
Country
Latvia
Facility Name
Investigational Site Number :4280002
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Investigational Site Number :4280003
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Investigational Site Number :4400001
City
Kaunas
ZIP/Postal Code
44320
Country
Lithuania
Facility Name
Investigational Site Number :4400003
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Facility Name
Investigational Site Number :4400008
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Investigational Site Number :4400007
City
Klaipeda
ZIP/Postal Code
92231
Country
Lithuania
Facility Name
Investigational Site Number :4400005
City
Vilnius
ZIP/Postal Code
04130
Country
Lithuania
Facility Name
Investigational Site Number :4840008
City
Benito Juarez
State/Province
Ciudad De Mexico
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Investigational Site Number :4840002
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Investigational Site Number :4840013
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Investigational Site Number :4840011
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Investigational Site Number :4840004
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Investigational Site Number :4840003
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Investigational Site Number :4840010
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Investigational Site Number :4840006
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Investigational Site Number :4840007
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Investigational Site Number :4840009
City
Mexico
ZIP/Postal Code
67000
Country
Mexico
Facility Name
Investigational Site Number :4840005
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Investigational Site Number :5280005
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Investigational Site Number :5280001
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Investigational Site Number :5280010
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Investigational Site Number :5280009
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Investigational Site Number :5280007
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Investigational Site Number :5280002
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Investigational Site Number :5280006
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Investigational Site Number :5280011
City
Roermond
ZIP/Postal Code
6043 CV
Country
Netherlands
Facility Name
Investigational Site Number :5280008
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Facility Name
Investigational Site Number :5280004
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Investigational Site Number :6040003
City
Chancay
Country
Peru
Facility Name
Investigational Site Number :6040002
City
Lima Lima
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Investigational Site Number :6040006
City
Lima
ZIP/Postal Code
021
Country
Peru
Facility Name
Investigational Site Number :6040004
City
Lima
ZIP/Postal Code
15004
Country
Peru
Facility Name
Investigational Site Number :6040001
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Investigational Site Number :6040005
City
Piura
ZIP/Postal Code
20000
Country
Peru
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 :6160010
City
Rzeszow
State/Province
Podkarpackie
ZIP/Postal Code
35-205
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 :6160018
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-611
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 :6160022
City
Ostrowiec Swietokrzyski
State/Province
Swietokrzyskie
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Investigational Site Number :6160014
City
Elblag
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Investigational Site Number :6160019
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Investigational Site Number :6160020
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Investigational Site Number :6200007
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Investigational Site Number :6200006
City
Aveiro
ZIP/Postal Code
3810-501
Country
Portugal
Facility Name
Investigational Site Number :6200008
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Investigational Site Number :6200011
City
Covilhã
ZIP/Postal Code
6200-251
Country
Portugal
Facility Name
Investigational Site Number :6200002
City
Guimarães
ZIP/Postal Code
4810-061
Country
Portugal
Facility Name
Investigational Site Number :6200005
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Facility Name
Investigational Site Number :6200009
City
Lisboa
ZIP/Postal Code
1769
Country
Portugal
Facility Name
Investigational Site Number :6200012
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Investigational Site Number :6200003
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Investigational Site Number :6200004
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Investigational Site Number :6425004
City
Bacau
ZIP/Postal Code
600252
Country
Romania
Facility Name
Investigational Site Number :6425003
City
Cluj-Napoca
ZIP/Postal Code
400275
Country
Romania
Facility Name
Investigational Site Number :6425005
City
Constanta
ZIP/Postal Code
900002
Country
Romania
Facility Name
Investigational Site Number :6425002
City
Iasi
ZIP/Postal Code
700732
Country
Romania
Facility Name
Investigational Site Number :6425006
City
Pitesti
ZIP/Postal Code
110117
Country
Romania
Facility Name
Investigational Site Number :6425001
City
Timisoara
ZIP/Postal Code
300134
Country
Romania
Facility Name
Investigational Site Number :6430011
City
Chelyabinsk
ZIP/Postal Code
454091
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Investigational Site Number :6430009
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Investigational Site Number :6430010
City
Ryazan
Country
Russian Federation
Facility Name
Investigational Site Number :6430013
City
Saint Petersburg
ZIP/Postal Code
198328
Country
Russian Federation
Facility Name
Investigational Site Number :6430014
City
Saint Petersburg
ZIP/Postal Code
928260
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number :6430012
City
Stavropol
ZIP/Postal Code
355020
Country
Russian Federation
Facility Name
Investigational Site Number :6430006
City
Tomsk
ZIP/Postal Code
634034
Country
Russian Federation
Facility Name
Investigational Site Number :6430008
City
Ulyanovsk
ZIP/Postal Code
432017
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
Investigational Site Number :6880005
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number :6880006
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number :6880007
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Investigational Site Number :6880003
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Investigational Site Number :6880001
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Investigational Site Number :6880002
City
Valjevo
ZIP/Postal Code
14000
Country
Serbia
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 :7030005
City
Kosice
ZIP/Postal Code
040 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 :7100015
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Investigational Site Number :7100004
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number :7100014
City
Chatsworth
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Investigational Site Number :7100001
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Investigational Site Number :7100013
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Investigational Site Number :7100003
City
Durban
ZIP/Postal Code
4071
Country
South Africa
Facility Name
Investigational Site Number :7100010
City
Durban
ZIP/Postal Code
4302
Country
South Africa
Facility Name
Investigational Site Number :7100002
City
Gatesville
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Investigational Site Number :7100009
City
Johannesburg
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Investigational Site Number :7100012
City
Middelburg
ZIP/Postal Code
1050
Country
South Africa
Facility Name
Investigational Site Number :7100006
City
Parow
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number :7100005
City
Pretoria
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Investigational Site Number :7100008
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site Number :7100011
City
Vereeniging
ZIP/Postal Code
1935
Country
South Africa
Facility Name
Investigational Site Number :7240007
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08003
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08023
Country
Spain
Facility Name
Investigational Site Number :7240009
City
Badalona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Investigational Site Number :7240012
City
Caceres
State/Province
Cáceres
ZIP/Postal Code
10002
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number :7240008
City
Valencia
State/Province
Valenciana, Comunidad
ZIP/Postal Code
46017
Country
Spain
Facility Name
Investigational Site Number :7240010
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number :7240011
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Investigational Site Number :8040011
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site Number :8040003
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Investigational Site Number :8040001
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Investigational Site Number :8040007
City
Kyiv
ZIP/Postal Code
01033
Country
Ukraine
Facility Name
Investigational Site Number :8040004
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Investigational Site Number :8040006
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
Investigational Site Number :8040010
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
Investigational Site Number :8040008
City
Zaporizhzhia
ZIP/Postal Code
69076
Country
Ukraine
Facility Name
Investigational Site Number :8040009
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Investigational Site Number :8260003
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Investigational Site Number :8260002
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY3 7DQ
Country
United Kingdom
Facility Name
Investigational Site Number :8260006
City
Swansea
State/Province
Neath Port Talbot
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Investigational Site Number :8260007
City
North Shields
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Investigational Site Number :8260004
City
South Shields
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE34 0PL
Country
United Kingdom
Facility Name
Investigational Site Number :8260013
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Investigational Site Number :8260012
City
Aylesbury
ZIP/Postal Code
HP218AL
Country
United Kingdom
Facility Name
Investigational Site Number :8260001
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Investigational Site Number :8260005
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Investigational Site Number :8260011
City
Chippenham
ZIP/Postal Code
SN15 2SB
Country
United Kingdom
Facility Name
Investigational Site Number :8260015
City
Derby
ZIP/Postal Code
DE223NE
Country
United Kingdom
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
Links:
URL
http://www.copdclinicalstudies.com/?utm_source=ctgov
Description
COPD Clinical Studies
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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