Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
NCT ID: NCT04456673
Last Updated: 2025-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
935 participants
INTERVENTIONAL
2020-07-06
2024-05-27
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dupilumab
Participants received dupilumab 300 mg subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks
Dupilumab SAR231893
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Placebo
Participants received placebo matched to dupilumab 300 mg SC injection q2w up to 52 weeks
Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Placebo
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Interventions
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Dupilumab SAR231893
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Placebo
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 participant was taking inhaled corticosteroid (ICS)/long-acting beta agonist (LABA)/long-acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations were recorded by the investigator and defined as AECOPD that required either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations had to require the use of systemic corticosteroids. Severe exacerbations were 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: Participants with blood eosinophils ≥300 cells/microliter at Visit 1.
* Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
* History of, or planned pneumonectomy or lung volume reduction surgery. Participants who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation \<4 weeks prior to screening (Note: participants 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.
Exclusion Criteria
* 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.
40 Years
85 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Cullman Research Center, LLC Site Number : 8400095
Cullman, Alabama, United States
Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090
Jasper, Alabama, United States
Scottsboro Quick Care Clinic Site Number : 8400116
Scottsboro, Alabama, United States
Phoenix Medical Group Site Number : 8400061
Peoria, Arizona, United States
Medical Advancement Center of Arizona Site Number : 8400107
Tempe, Arizona, United States
Asthma and Allergy Institute Site Number : 8400022
Little Rock, Arkansas, United States
Kern Research, Inc Site Number : 8400031
Bakersfield, California, United States
NewportNativeMD, Inc Site Number : 8400032
Newport Beach, California, United States
Prospective Research Innovations, Inc. Site Number : 8400063
Rancho Cucamonga, California, United States
ACRC Studies Site Number : 8400094
San Diego, California, United States
Institute of HealthCare Assessment, Inc. Site Number : 8400015
San Diego, California, United States
Allianz Research Institute Site Number : 8400007
Westminster, California, United States
Innovative Clinical Research Site Number : 8400018
Lafayette, Colorado, United States
Helix Biomedics, LLC Site Number : 8400035
Boynton Beach, Florida, United States
Pioneer Clinical Research Site Number : 8400043
Boynton Beach, Florida, United States
Renaissance Research and Medical Group, Inc Site Number : 8400092
Cape Coral, Florida, United States
St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020
Clearwater, Florida, United States
Beautiful Minds Clinical Research Center Site Number : 8400081
Cutler Bay, Florida, United States
Omega Research Consultants, LLC Site Number : 8400021
DeBary, Florida, United States
Sciences Connections, LLC Site Number : 8400133
Doral, Florida, United States
InvesClinic, LLC Site Number : 8400039
Fort Lauderdale, Florida, United States
Finlay Medical Research Site Number : 8400071
Greenacres City, Florida, United States
Direct Helpers Medical Center Inc Site Number : 8400079
Hialeah, Florida, United States
DL Research Solutions Inc Site Number : 8400089
Miami, Florida, United States
Phoenix Medical Research, LLC Site Number : 8400012
Miami, Florida, United States
Columbus Clinical Services Site Number : 8400062
Miami, Florida, United States
Reed Medical Research Site Number : 8400123
Miami, Florida, United States
De La Cruz Research Center, LLC Site Number : 8400075
Miami, Florida, United States
Florida Institute for Clinical Research Site Number : 8400129
Orlando, Florida, United States
Central Florida Pulmonary Group, PA Site Number : 8400101
Orlando, Florida, United States
Innovation Medical Research Center Site Number : 8400114
Palmetto Bay, Florida, United States
Family Medical Specialists of Florida, PA Site Number : 8400077
Plant City, Florida, United States
Coastal Pulmonary And Critical Care Site Number : 8400013
St. Petersburg, Florida, United States
Florida Pulmonary Research Center Site Number : 8400001
Winter Park, Florida, United States
Appalachian Clinical Research Site Number : 8400048
Adairsville, Georgia, United States
Northlake Medical Group Site Number : 8400099
Atlanta, Georgia, United States
River Birch Research, LLC Site Number : 8400045
Blue Ridge, Georgia, United States
Medical Centre of Conyers Site Number : 8400064
Conyers, Georgia, United States
David Kavtaradze MD, Inc. Site Number : 8400135
Cordele, Georgia, United States
Gwinnett Biomedical Research Site Number : 8400052
Lawrenceville, Georgia, United States
Southeast Lung Associates Site Number : 8400003
Rincon, Georgia, United States
Herman Clinical Research LLC Site Number : 8400078
Suwanee, Georgia, United States
Avant Research Associates LLC Site Number : 8400118
Crowley, Louisiana, United States
Genesis Clinical Research & Consulting Site Number : 8400050
Fall River, Massachusetts, United States
Infinity Medical Research Site Number : 8400004
South Dartmouth, Massachusetts, United States
Henry Ford Health System Site Number : 8400053
Detroit, Michigan, United States
Revive Research Institute Site Number : 8400120
Lathrup Village, Michigan, United States
Romedica, LLC Site Number : 8400034
Rochester, Michigan, United States
Covenant Healthcare Site Number : 8400057
Saginaw, Michigan, United States
Great Lakes Research Institute Site Number : 8400096
Southfield, Michigan, United States
Montana Medical Research Site Number : 8400019
Missoula, Montana, United States
Somnos Clinical Research Site Number : 8400016
Lincoln, Nebraska, United States
Quality Clinical Research, Inc. Site Number : 8400073
Omaha, Nebraska, United States
Jersey City Breathing Center Site Number : 8400137
Jersey City, New Jersey, United States
WellNow Urgent Care Site Number : 8400132
East Amherst, New York, United States
Northwell Health Site Number : 8400054
New Hyde Park, New York, United States
Mid Hudson Medical Research PLLC Site Number : 8400037
New Windsor, New York, United States
Great Lakes Medical Research Site Number : 8400044
Westfield, New York, United States
Onsite Clinical Solutions LLC Site Number : 8400042
Charlotte, North Carolina, United States
Clinical Research of Gastonia Site Number : 8400010
Gastonia, North Carolina, United States
Monroe Biomedical Research Site Number : 8400087
Monroe, North Carolina, United States
Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006
Mooresville, North Carolina, United States
Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117
Mooresville, North Carolina, United States
Coastal Carolina Health Care, P.A. Site Number : 8400025
New Bern, North Carolina, United States
Southeastern Research Center Site Number : 8400068
Winston-Salem, North Carolina, United States
Optimed Research, LTD Site Number : 8400082
Columbus, Ohio, United States
Toledo Institute of Clinical Research Site Number : 8400024
Toledo, Ohio, United States
Allergy, Asthma and Clinical Research Center Site Number : 8400127
Oklahoma City, Oklahoma, United States
Clinical Research of Central PA Site Number : 8400009
DuBois, Pennsylvania, United States
Frontier Clinical Research, LLC Site Number : 8400049
Scottdale, Pennsylvania, United States
Carolina Medical Research, LLC Site Number : 8400026
Clinton, South Carolina, United States
MD First Research Site Number : 8400105
Lancaster, South Carolina, United States
LLM Research Site Number : 8400125
Myrtle Beach, South Carolina, United States
Health Concepts Site Number : 8400027
Rapid City, South Dakota, United States
Pulmonary & Sleep Specialists Site Number : 8400136
Dickson, Tennessee, United States
Clinical Trials Center of Middle Tennessee Site Number : 8400066
Franklin, Tennessee, United States
MultiSpecialty Clinical Research Site Number : 8400110
Johnson City, Tennessee, United States
REX Clinical Trials Site Number : 8400143
Beaumont, Texas, United States
Clinrx Research Site Number : 8400059
Carrollton, Texas, United States
Houston Pulmonary and Sleep Associates Site Number : 8400011
Cypress, Texas, United States
Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055
Houston, Texas, United States
Prolato Clinical Research Center Site Number : 8400128
Houston, Texas, United States
Pioneer Research Solutions, Inc. Site Number : 8400070
Houston, Texas, United States
Radiance Clinical Research Site Number : 8400029
Lampasas, Texas, United States
DCOL Center for Clinical Research Site Number : 8400028
Longview, Texas, United States
Metroplex Pulmonary and Sleep Center Site Number : 8400131
McKinney, Texas, United States
Clinrx Research, LLC Site Number : 8400069
Plano, Texas, United States
Diagnostics Research Group Site Number : 8400038
San Antonio, Texas, United States
Mt. Olympus Medical Research Site Number : 8400115
Sugar Land, Texas, United States
Pulmonary Research of Abingdon, LLC Site Number : 8400030
Abingdon, Virginia, United States
Clinical Research Partners Site Number : 8400040
Richmond, Virginia, United States
Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088
Greenfield, Wisconsin, United States
Investigational Site Number : 0320007
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320006
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320004
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320001
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320003
CABA, Buenos Aires, Argentina
Investigational Site Number : 0320010
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320013
Lobos, Buenos Aires, Argentina
Investigational Site Number : 0320005
Quilmes, Buenos Aires F.D., Argentina
Investigational Site Number : 0320011
Córdoba, Córdoba Province, Argentina
Investigational Site Number : 0320008
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320009
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320002
Buenos Aires, , Argentina
Investigational Site Number : 0320012
Launs Este, , Argentina
Investigational Site Number : 0360008
Kent Town, South Australia, Australia
Investigational Site Number : 0360005
Clayton, Victoria, Australia
Investigational Site Number : 0360001
Spearwood, Western Australia, Australia
Investigational Site Number : 0560002
Edegem, , Belgium
Investigational Site Number : 0560001
Leuven, , Belgium
Investigational Site Number : 0560003
Liège, , Belgium
Investigational Site Number : 0560004
Mechelen, , Belgium
CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760020
Vitória, Espírito Santo, Brazil
SER da Bahia Site Number : 0760019
Salvador, Estado de Bahia, Brazil
Instituto Mederi de Pesquisa e Saude Site Number : 0760008
Passo Fundo, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760017
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
HOSPITAL DIA DO PULMAO Site Number : 0760006
Blumenau, Santa Catarina, Brazil
UFSC - Hospital Universitário Site Number : 0760018
Florianópolis, Santa Catarina, Brazil
PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760015
Campinas, São Paulo, Brazil
FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760007
Santo André, São Paulo, Brazil
CPQuali Pesquisa Clinica Site Number : 0760003
São Paulo, São Paulo, Brazil
Instituto de Pesquisa Grupo NotreDame Intermedica Site Number : 0760012
São Paulo, São Paulo, Brazil
Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760021
São Paulo, São Paulo, Brazil
InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002
São Paulo, São Paulo, Brazil
Clinica de Alergia Martti Antila Site Number : 0760009
Sorocaba, São Paulo, Brazil
Investigational Site Number : 1005025
Burgas, , Bulgaria
Investigational Site Number : 1005021
Dupnitsa, , Bulgaria
Investigational Site Number : 1005012
Haskovo, , Bulgaria
Investigational Site Number : 1005011
Montana, , Bulgaria
Investigational Site Number : 1005008
Plovdiv, , Bulgaria
Investigational Site Number : 1005015
Rousse, , Bulgaria
Investigational Site Number : 1005013
Rousse, , Bulgaria
Investigational Site Number : 1005018
Sofia, , Bulgaria
Investigational Site Number : 1005003
Sofia, , Bulgaria
Investigational Site Number : 1005001
Sofia, , Bulgaria
Investigational Site Number : 1005006
Sofia, , Bulgaria
Investigational Site Number : 1005002
Sofia, , Bulgaria
Investigational Site Number : 1005026
Sofia, , Bulgaria
Investigational Site Number : 1005024
Stara Zagora, , Bulgaria
Investigational Site Number : 1005004
Stara Zagora, , Bulgaria
Investigational Site Number : 1005023
Veliko Tyrnovo, , Bulgaria
Investigational Site Number : 1005027
Veliko Tyrnovo, , Bulgaria
Investigational Site Number : 1005019
Vidin, , Bulgaria
Investigational Site Number : 1005020
Vratsa, , Bulgaria
Investigational Site Number : 1240015
Calgary, Alberta, Canada
Investigational Site Number : 1240018
Kamloops, British Columbia, Canada
Investigational Site Number : 1240017
Kelowna, British Columbia, Canada
Investigational Site Number : 1240014
Moncton, New Brunswick, Canada
Investigational Site Number : 1240010
Ajax, Ontario, Canada
Investigational Site Number : 1240009
Sarnia, Ontario, Canada
Investigational Site Number : 1240007
Windsor, Ontario, Canada
Investigational Site Number : 1240004
Montreal, Quebec, Canada
Investigational Site Number : 1240012
Québec, Quebec, Canada
Investigational Site Number : 1240001
Québec, , Canada
Investigational Site Number : 1240005
Québec, , Canada
Investigational Site Number : 1520009
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520006
Curicó, Maule Region, Chile
Investigational Site Number : 1520001
Talca, Maule Region, Chile
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Quillota, Región de Valparaíso, Chile
Investigational Site Number : 1700002
Bogotá, , Colombia
Investigational Site Number : 1700007
Bucaramanga, , Colombia
Investigational Site Number : 1700005
Manizales, , Colombia
Investigational Site Number : 2030009
Havlíčkův Brod, , Czechia
Investigational Site Number : 2030004
Jihlava, , Czechia
Investigational Site Number : 2030001
Jindrichuv Hradec III, , Czechia
Investigational Site Number : 2030007
Kralupy nad Vltavou, , Czechia
Investigational Site Number : 2030003
Miroslav, , Czechia
Investigational Site Number : 2030010
Nymburk, , Czechia
Investigational Site Number : 2030002
Strakonice, , Czechia
Investigational Site Number : 2500009
Bayonne, , France
Investigational Site Number : 2500002
Dijon, , France
Investigational Site Number : 2500005
Lyon, , France
Investigational Site Number : 2500003
Montpellier, , France
Investigational Site Number : 2500007
Paris, , France
Investigational Site Number : 2500008
Paris, , France
Investigational Site Number : 2500006
Pessac, , France
Investigational Site Number : 2500001
Saint-Herblain, , France
Investigational Site Number : 2760024
Berlin, , Germany
Investigational Site Number : 2760025
Berlin, , Germany
Investigational Site Number : 2760017
Darmstadt, , Germany
Investigational Site Number : 2760009
Frankfurt am Main, , Germany
Investigational Site Number : 2760002
Hamburg, , Germany
Investigational Site Number : 2760003
Hanover, , Germany
Investigational Site Number : 2760007
Koblenz, , Germany
Investigational Site Number : 2760023
Leipzig, , Germany
Investigational Site Number : 2760011
Leipzig, , Germany
Investigational Site Number : 2760010
Lübeck, , Germany
Investigational Site Number : 2760012
Mainz, , Germany
Investigational Site Number : 2760008
Marburg, , Germany
Investigational Site Number : 2760020
Peine, , Germany
Investigational Site Number : 2760016
Rosenheim, , Germany
Investigational Site Number : 2760018
Wiesbaden, , Germany
Investigational Site Number : 3000006
Athens, , Greece
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000003
Heraklion, , Greece
Investigational Site Number : 3000002
Ioannina, , Greece
Investigational Site Number : 3000007
Palaio Faliro, Athens, , Greece
Investigational Site Number : 3000004
Thessaloniki, , Greece
Investigational Site Number : 3480003
Edelény, , Hungary
Investigational Site Number : 3480004
Gödöllö, , Hungary
Investigational Site Number : 3480002
Hajdunánás, , Hungary
Investigational Site Number : 3480006
Mosonmagyaróvár, , Hungary
Investigational Site Number : 3480001
Százhalombatta, , Hungary
Investigational Site Number : 3480005
Szombathely, , Hungary
Investigational Site Number : 4280008
Balvi, , Latvia
Investigational Site Number : 4280007
Rēzekne, , Latvia
Investigational Site Number : 4280001
Riga, , Latvia
Investigational Site Number : 4280005
Riga, , Latvia
Investigational Site Number : 4280006
Riga, , Latvia
Investigational Site Number : 4280002
Riga, , Latvia
Investigational Site Number : 4280003
Riga, , Latvia
Investigational Site Number : 4400001
Kaunas, , Lithuania
Investigational Site Number : 4400003
Kaunas, , Lithuania
Investigational Site Number : 4400008
Kaunas, , Lithuania
Investigational Site Number : 4400007
Klaipėda, , Lithuania
Investigational Site Number : 4400005
Vilnius, , Lithuania
Investigational Site Number : 4840002
Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840013
Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840011
Zapopan, Jalisco, Mexico
Investigational Site Number : 4840008
Benito Juárez, Mexico City, Mexico
Investigational Site Number : 4840004
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840003
Monterrey, Nuevo León, Mexico
Investigational Site Number : 4840010
Chihuahua City, , Mexico
Investigational Site Number : 4840006
Durango, , Mexico
Investigational Site Number : 4840007
Mexico City, , Mexico
Investigational Site Number : 4840009
Mexico City, , Mexico
Investigational Site Number : 4840005
Veracruz, , Mexico
Investigational Site Number : 5280005
Arnhem, , Netherlands
Investigational Site Number : 5280001
Breda, , Netherlands
Investigational Site Number : 5280010
Dordrecht, , Netherlands
Investigational Site Number : 5280009
Harderwijk, , Netherlands
Investigational Site Number : 5280002
Leeuwarden, , Netherlands
Investigational Site Number : 5280006
Nijmegen, , Netherlands
Investigational Site Number : 5280011
Roermond, , Netherlands
Investigational Site Number : 5280008
Zutphen, , Netherlands
Investigational Site Number : 5280004
Zwolle, , Netherlands
Investigational Site Number : 6040006
Lima, , Peru
Investigational Site Number : 6040004
Lima, , Peru
Investigational Site Number : 6040001
Lima, , Peru
Investigational Site Number : 6040002
Lima Lima, , Peru
Investigational Site Number : 6040005
Piura, , Peru
Investigational Site Number : 6160009
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number : 6160007
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160015
Grodzisk Mazowiecki, Masovian Voivodeship, Poland
Investigational Site Number : 6160010
Rzeszów, Podkarpackie Voivodeship, Poland
Investigational Site Number : 6160008
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160018
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160011
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160014
Elblag, Warmian-Masurian Voivodeship, Poland
Investigational Site Number : 6160019
Krakow, , Poland
Investigational Site Number : 6160020
Nowa Sól, , Poland
Investigational Site Number : 6160022
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 6200007
Almada, , Portugal
Investigational Site Number : 6200006
Aveiro, , Portugal
Investigational Site Number : 6200002
Guimarães, , Portugal
Investigational Site Number : 6200009
Lisbon, , Portugal
Investigational Site Number : 6200012
Matosinhos Municipality, , Portugal
Investigational Site Number : 6425004
Bacau, , Romania
Investigational Site Number : 6425003
Cluj-Napoca, , Romania
Investigational Site Number : 6425005
Constanța, , Romania
Investigational Site Number : 6425002
Iași, , Romania
Investigational Site Number : 6425006
Piteşti, , Romania
Investigational Site Number : 6425001
Timișoara, , Romania
Investigational Site Number : 6430001
Moscow, , Russia
Investigational Site Number : 6430003
Moscow, , Russia
Investigational Site Number : 6430002
Moscow, , Russia
Investigational Site Number : 6430009
Nizhny Novgorod, , Russia
Investigational Site Number : 6430010
Ryazan, , Russia
Investigational Site Number : 6430004
Saint Petersburg, , Russia
Investigational Site Number : 6430013
Saint Petersburg, , Russia
Investigational Site Number : 6430014
Saint Petersburg, , Russia
Investigational Site Number : 6430012
Stavropol, , Russia
Investigational Site Number : 6430006
Tomsk, , Russia
Investigational Site Number : 6430008
Ulyanovsk, , Russia
Investigational Site Number : 6430005
Voronezh, , Russia
Investigational Site Number : 6880005
Belgrade, , Serbia
Investigational Site Number : 6880006
Belgrade, , Serbia
Investigational Site Number : 6880007
Belgrade, , Serbia
Investigational Site Number : 6880001
Kamenitz, , Serbia
Investigational Site Number : 6880003
Kragujevac, , Serbia
Investigational Site Number : 6880002
Valjevo, , Serbia
Investigational Site Number : 7030007
Banská Bystrica, , Slovakia
Investigational Site Number : 7030006
Humenné, , Slovakia
Investigational Site Number : 7030005
Košice, , Slovakia
Investigational Site Number : 7030003
Levice, , Slovakia
Investigational Site Number : 7030001
Poprad, , Slovakia
Investigational Site Number : 7030002
Spišská Nová Ves, , Slovakia
Investigational Site Number : 7100015
Benoni, , South Africa
Investigational Site Number : 7100004
Cape Town, , South Africa
Investigational Site Number : 7100014
Chatsworth, , South Africa
Investigational Site Number : 7100001
Durban, , South Africa
Investigational Site Number : 7100013
Durban, , South Africa
Investigational Site Number : 7100003
Durban, , South Africa
Investigational Site Number : 7100010
Durban, , South Africa
Investigational Site Number : 7100002
Gatesville, , South Africa
Investigational Site Number : 7100011
Gauteng, , South Africa
Investigational Site Number : 7100009
Johannesburg, , South Africa
Investigational Site Number : 7100012
Middelburg, , South Africa
Investigational Site Number : 7100006
Parow, , South Africa
Investigational Site Number : 7100005
Pretoria, , South Africa
Investigational Site Number : 7100008
Somerset West, , South Africa
Investigational Site Number : 7240002
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009
Badalona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240012
Cáceres, Cáceres, Spain
Investigational Site Number : 7240003
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240007
Oviedo, Principality of Asturias, Spain
Investigational Site Number : 7240008
Valencia, Valenciana, Comunidad, Spain
Investigational Site Number : 7240010
Málaga, , Spain
Investigational Site Number : 7240011
Zaragoza, , Spain
Investigational Site Number : 8040011
Chernivtsi, , Ukraine
Investigational Site Number : 8040002
Ivano-Frankivsk, , Ukraine
Investigational Site Number : 8040003
Ivano-Frankivsk, , Ukraine
Investigational Site Number : 8040001
Kharkiv, , Ukraine
Investigational Site Number : 8040007
Kyiv, , Ukraine
Investigational Site Number : 8040004
Kyiv, , Ukraine
Investigational Site Number : 8040006
Lviv, , Ukraine
Investigational Site Number : 8040010
Ternopil, , Ukraine
Investigational Site Number : 8040008
Zaporizhzhia, , Ukraine
Investigational Site Number : 8040009
Zaporizhzhya, , Ukraine
Investigational Site Number : 8260003
Cambridge, Cambridgeshire, United Kingdom
Investigational Site Number : 8260002
Blackpool, Lancashire, United Kingdom
Investigational Site Number : 8260006
Swansea, Neath Port Talbot, United Kingdom
Investigational Site Number : 8260007
North Shields, Newcastle Upon Tyne, United Kingdom
Investigational Site Number : 8260004
South Shields, Newcastle Upon Tyne, United Kingdom
Investigational Site Number : 8260013
Nottingham, Nottinghamshire, United Kingdom
Investigational Site Number : 8260012
Aylesbury, , United Kingdom
Investigational Site Number : 8260001
Bradford, , United Kingdom
Investigational Site Number : 8260005
Bristol, , United Kingdom
Investigational Site Number : 8260011
Chippenham, , United Kingdom
Investigational Site Number : 8260015
Derby, , United Kingdom
Countries
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References
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Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB. Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS. Chest. 2025 Jul;168(1):56-66. doi: 10.1016/j.chest.2025.01.029. Epub 2025 Jan 31.
Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Patel N, Yancopoulos GD, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB; NOTUS Study Investigators. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. N Engl J Med. 2024 Jun 27;390(24):2274-2283. doi: 10.1056/NEJMoa2401304. Epub 2024 May 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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EFC15805 Plain language Results Summary
Other Identifiers
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U1111-1211-8837
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-001954-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC15805
Identifier Type: -
Identifier Source: org_study_id
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