AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3NOTUSNCT04456673

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

A Phase 3 study testing Dupilumab SAR231893, Inhaled Corticosteroid and Inhaled Long-Acting Beta Agonist in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 334 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Dupilumab SAR231893, Inhaled Corticosteroid and Inhaled Long-Acting Beta Agonist
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
935 participants
Where
334 sitesin 29 countries
Study dates
6 Jul 2020to 27 May 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with a physician diagnosis of COPD who met 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 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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. 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.

Trial locations and contacts

334 sites in 29 countries.

334 sites in 29 countries

United States92 sites

  • Pulmonary Research of Abingdon, LLC Site Number : 8400030

    Abingdon, Virginia, 24210

  • Appalachian Clinical Research Site Number : 8400048

    Adairsville, Georgia, 30103

  • Northlake Medical Group Site Number : 8400099

    Atlanta, Georgia, 30345

  • Kern Research, Inc Site Number : 8400031

    Bakersfield, California, 93301

  • REX Clinical Trials Site Number : 8400143

    Beaumont, Texas, 77701

  • River Birch Research, LLC Site Number : 8400045

    Blue Ridge, Georgia, 30513

  • Helix Biomedics, LLC Site Number : 8400035

    Boynton Beach, Florida, 33435

  • Pioneer Clinical Research Site Number : 8400043

    Boynton Beach, Florida, 33437

  • Renaissance Research and Medical Group, Inc Site Number : 8400092

    Cape Coral, Florida, 33991

  • Clinrx Research Site Number : 8400059

    Carrollton, Texas, 75007

  • Onsite Clinical Solutions LLC Site Number : 8400042

    Charlotte, North Carolina, 28277

  • St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020

    Clearwater, Florida, 33765

  • Carolina Medical Research, LLC Site Number : 8400026

    Clinton, South Carolina, 29325

  • Optimed Research, LTD Site Number : 8400082

    Columbus, Ohio, 43235

  • Medical Centre of Conyers Site Number : 8400064

    Conyers, Georgia, 30094

  • David Kavtaradze MD, Inc. Site Number : 8400135

    Cordele, Georgia, 31015

  • Avant Research Associates LLC Site Number : 8400118

    Crowley, Louisiana, 70526

  • Cullman Research Center, LLC Site Number : 8400095

    Cullman, Alabama, 35055

  • Beautiful Minds Clinical Research Center Site Number : 8400081

    Cutler Bay, Florida, 33157

  • Houston Pulmonary and Sleep Associates Site Number : 8400011

    Cypress, Texas, 77429

  • Omega Research Consultants, LLC Site Number : 8400021

    DeBary, Florida, 32713

  • Henry Ford Health System Site Number : 8400053

    Detroit, Michigan, 48202

  • Pulmonary & Sleep Specialists Site Number : 8400136

    Dickson, Tennessee, 37055

  • Sciences Connections, LLC Site Number : 8400133

    Doral, Florida, 33178

  • Clinical Research of Central PA Site Number : 8400009

    DuBois, Pennsylvania, 15801

  • WellNow Urgent Care Site Number : 8400132

    East Amherst, New York, 14051

  • Genesis Clinical Research & Consulting Site Number : 8400050

    Fall River, Massachusetts, 02723

  • InvesClinic, LLC Site Number : 8400039

    Fort Lauderdale, Florida, 33308

  • Clinical Trials Center of Middle Tennessee Site Number : 8400066

    Franklin, Tennessee, 37067

  • Clinical Research of Gastonia Site Number : 8400010

    Gastonia, North Carolina, 28054

  • Finlay Medical Research Site Number : 8400071

    Greenacres City, Florida, 33467

  • Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088

    Greenfield, Wisconsin, 53228

  • Direct Helpers Medical Center Inc Site Number : 8400079

    Hialeah, Florida, 33012

  • Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055

    Houston, Texas, 77043-2742

  • Prolato Clinical Research Center Site Number : 8400128

    Houston, Texas, 77054

  • Pioneer Research Solutions, Inc. Site Number : 8400070

    Houston, Texas, 77099

  • Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090

    Jasper, Alabama, 35501

  • Jersey City Breathing Center Site Number : 8400137

    Jersey City, New Jersey, 07304

  • MultiSpecialty Clinical Research Site Number : 8400110

    Johnson City, Tennessee, 37601

  • Innovative Clinical Research Site Number : 8400018

    Lafayette, Colorado, 80026

  • Radiance Clinical Research Site Number : 8400029

    Lampasas, Texas, 76550-1820

  • MD First Research Site Number : 8400105

    Lancaster, South Carolina, 29720

  • Revive Research Institute Site Number : 8400120

    Lathrup Village, Michigan, 48076

  • Gwinnett Biomedical Research Site Number : 8400052

    Lawrenceville, Georgia, 30046

  • Somnos Clinical Research Site Number : 8400016

    Lincoln, Nebraska, 68510

  • Asthma and Allergy Institute Site Number : 8400022

    Little Rock, Arkansas, 72209

  • DCOL Center for Clinical Research Site Number : 8400028

    Longview, Texas, 75605

  • Metroplex Pulmonary and Sleep Center Site Number : 8400131

    McKinney, Texas, 75069

  • DL Research Solutions Inc Site Number : 8400089

    Miami, Florida, 33155

  • Phoenix Medical Research, LLC Site Number : 8400012

    Miami, Florida, 33165

  • Columbus Clinical Services Site Number : 8400062

    Miami, Florida, 33174

  • Reed Medical Research Site Number : 8400123

    Miami, Florida, 33176

  • De La Cruz Research Center, LLC Site Number : 8400075

    Miami, Florida, 33184

  • Montana Medical Research Site Number : 8400019

    Missoula, Montana, 59808

  • Monroe Biomedical Research Site Number : 8400087

    Monroe, North Carolina, 28112

  • Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006

    Mooresville, North Carolina, 28117

  • Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117

    Mooresville, North Carolina, 28117

  • LLM Research Site Number : 8400125

    Myrtle Beach, South Carolina, 29577

  • Coastal Carolina Health Care, P.A. Site Number : 8400025

    New Bern, North Carolina, 28562

  • Northwell Health Site Number : 8400054

    New Hyde Park, New York, 11040

  • Mid Hudson Medical Research PLLC Site Number : 8400037

    New Windsor, New York, 12553-7754

  • NewportNativeMD, Inc Site Number : 8400032

    Newport Beach, California, 92663

  • Allergy, Asthma and Clinical Research Center Site Number : 8400127

    Oklahoma City, Oklahoma, 73120

  • Quality Clinical Research, Inc. Site Number : 8400073

    Omaha, Nebraska, 68114

  • Florida Institute for Clinical Research Site Number : 8400129

    Orlando, Florida, 32825-4454

  • Central Florida Pulmonary Group, PA Site Number : 8400101

    Orlando, Florida, 32825

  • Innovation Medical Research Center Site Number : 8400114

    Palmetto Bay, Florida, 33157

  • Phoenix Medical Group Site Number : 8400061

    Peoria, Arizona, 85381

  • Clinrx Research, LLC Site Number : 8400069

    Plano, Texas, 75024

  • Family Medical Specialists of Florida, PA Site Number : 8400077

    Plant City, Florida, 33563

  • Prospective Research Innovations, Inc. Site Number : 8400063

    Rancho Cucamonga, California, 91730

  • Health Concepts Site Number : 8400027

    Rapid City, South Dakota, 57702

  • Clinical Research Partners Site Number : 8400040

    Richmond, Virginia, 23236

  • Southeast Lung Associates Site Number : 8400003

    Rincon, Georgia, 31326

  • Romedica, LLC Site Number : 8400034

    Rochester, Michigan, 48307

  • Covenant Healthcare Site Number : 8400057

    Saginaw, Michigan, 48638

  • Diagnostics Research Group Site Number : 8400038

    San Antonio, Texas, 78229

  • ACRC Studies Site Number : 8400094

    San Diego, California, 92119

  • Institute of HealthCare Assessment, Inc. Site Number : 8400015

    San Diego, California, 92120

  • Frontier Clinical Research, LLC Site Number : 8400049

    Scottdale, Pennsylvania, 15683

  • Scottsboro Quick Care Clinic Site Number : 8400116

    Scottsboro, Alabama, 35768

  • Infinity Medical Research Site Number : 8400004

    South Dartmouth, Massachusetts, 02747

  • Great Lakes Research Institute Site Number : 8400096

    Southfield, Michigan, 48075-5400

  • Coastal Pulmonary And Critical Care Site Number : 8400013

    St. Petersburg, Florida, 33704

  • Mt. Olympus Medical Research Site Number : 8400115

    Sugar Land, Texas, 77479

  • Herman Clinical Research LLC Site Number : 8400078

    Suwanee, Georgia, 30024

  • Medical Advancement Center of Arizona Site Number : 8400107

    Tempe, Arizona, 85283

  • Toledo Institute of Clinical Research Site Number : 8400024

    Toledo, Ohio, 43617

  • Great Lakes Medical Research Site Number : 8400044

    Westfield, New York, 14787

  • Allianz Research Institute Site Number : 8400007

    Westminster, California, 92683

  • Southeastern Research Center Site Number : 8400068

    Winston-Salem, North Carolina, 27103

  • Florida Pulmonary Research Center Site Number : 8400001

    Winter Park, Florida, 32789

Other trials in United States

Bulgaria19 sites

  • Investigational Site Number : 1005025

    Burgas, 8000

  • Investigational Site Number : 1005021

    Dupnitsa, 2600

  • Investigational Site Number : 1005012

    Haskovo, 6305

  • Investigational Site Number : 1005011

    Montana, 3403

  • Investigational Site Number : 1005008

    Plovdiv, 4002

  • Investigational Site Number : 1005015

    Rousse, 70000

  • Investigational Site Number : 1005013

    Rousse, 7002

  • Investigational Site Number : 1005018

    Sofia, 1000

  • Investigational Site Number : 1005003

    Sofia, 1142

  • Investigational Site Number : 1005001

    Sofia, 1233

  • Investigational Site Number : 1005006

    Sofia, 1233

  • Investigational Site Number : 1005002

    Sofia, 1407

  • Investigational Site Number : 1005026

    Sofia, 1618

  • Investigational Site Number : 1005024

    Stara Zagora, 6000

  • Investigational Site Number : 1005004

    Stara Zagora, 6001

  • Investigational Site Number : 1005023

    Veliko Tarnovo, 5000

  • Investigational Site Number : 1005027

    Veliko Tarnovo, 5000

  • Investigational Site Number : 1005019

    Vidin, 3700

  • Investigational Site Number : 1005020

    Vratsa, 3000

Other trials in Bulgaria

Germany15 sites

  • Investigational Site Number : 2760024

    Berlin, 10961

  • Investigational Site Number : 2760025

    Berlin, 12159

  • Investigational Site Number : 2760017

    Darmstadt, 64283

  • Investigational Site Number : 2760009

    Frankfurt am Main, 60596

  • Investigational Site Number : 2760002

    Hamburg, 20354

  • Investigational Site Number : 2760003

    Hanover, 30173

  • Investigational Site Number : 2760007

    Koblenz, 56068

  • Investigational Site Number : 2760023

    Leipzig, 04299

  • Investigational Site Number : 2760011

    Leipzig, 04347

  • Investigational Site Number : 2760010

    Lübeck, 23552

  • Investigational Site Number : 2760012

    Mainz, 55128

  • Investigational Site Number : 2760008

    Marburg, 35043

  • Investigational Site Number : 2760020

    Peine, 31224

  • Investigational Site Number : 2760016

    Rosenheim, 83022

  • Investigational Site Number : 2760018

    Wiesbaden, 65183

Other trials in Germany

Brazil14 sites

  • HOSPITAL DIA DO PULMAO Site Number : 0760006

    Blumenau, Santa Catarina, 89030-100

  • PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760015

    Campinas, São Paulo, 13059-900

  • UFSC - Hospital Universitário Site Number : 0760018

    Florianópolis, Santa Catarina, 88040-970

  • Instituto Mederi de Pesquisa e Saude Site Number : 0760008

    Passo Fundo, Rio Grande do Sul, 99010-120

  • Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760017

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Sao Lucas Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90160-090

  • SER da Bahia Site Number : 0760019

    Salvador, Estado de Bahia, 40150-150

  • FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760007

    Santo André, São Paulo, 09060-870

  • CPQuali Pesquisa Clinica Site Number : 0760003

    São Paulo, São Paulo, 01228-000

  • Instituto de Pesquisa Grupo NotreDame Intermedica Site Number : 0760012

    São Paulo, São Paulo, 01229-010

  • Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760021

    São Paulo, São Paulo, 04014-002

  • InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002

    São Paulo, São Paulo, 05403-900

  • Clinica de Alergia Martti Antila Site Number : 0760009

    Sorocaba, São Paulo, 18040-425

  • CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760020

    Vitória, Espírito Santo, 29055 450

Other trials in Brazil

South Africa14 sites

  • Investigational Site Number : 7100015

    Benoni, 1500

  • Investigational Site Number : 7100004

    Cape Town, 7500

  • Investigational Site Number : 7100014

    Chatsworth, 4091

  • Investigational Site Number : 7100001

    Durban, 4001

  • Investigational Site Number : 7100013

    Durban, 4001

  • Investigational Site Number : 7100003

    Durban, 4071

  • Investigational Site Number : 7100010

    Durban, 4302

  • Investigational Site Number : 7100002

    Gatesville, 7764

  • Investigational Site Number : 7100011

    Gauteng, 1935

  • Investigational Site Number : 7100009

    Johannesburg, 0157

  • Investigational Site Number : 7100012

    Middelburg, 1050

  • Investigational Site Number : 7100006

    Parow, 7500

  • Investigational Site Number : 7100005

    Pretoria, 0157

  • Investigational Site Number : 7100008

    Somerset West, 7130

Other trials in South Africa

Argentina13 sites

  • Investigational Site Number : 0320007

    Berazategui, Buenos Aires, CP 1884

  • Investigational Site Number : 0320002

    Buenos Aires, C1121ABE

  • Investigational Site Number : 0320006

    CABA, Buenos Aires, C1122AAK

  • Investigational Site Number : 0320004

    CABA, Buenos Aires, C1414AIF

  • Investigational Site Number : 0320001

    CABA, Buenos Aires, C1425BEN

  • Investigational Site Number : 0320003

    CABA, Buenos Aires, C1425FVH

  • Investigational Site Number : 0320011

    Córdoba, Córdoba Province, X5003DCE

  • Investigational Site Number : 0320010

    La Plata, Buenos Aires, B1900BNN

  • Investigational Site Number : 0320012

    Launs Este, B1824KAJ

  • Investigational Site Number : 0320013

    Lobos, Buenos Aires, 7240

  • Investigational Site Number : 0320005

    Quilmes, Buenos Aires F.D., B1878FNR

  • Investigational Site Number : 0320008

    Rosario, Santa Fe Province, S2000DEJ

  • Investigational Site Number : 0320009

    Rosario, Santa Fe Province, S2002OJP

Other trials in Argentina

Russia12 sites

  • Investigational Site Number : 6430001

    Moscow, 115093

  • Investigational Site Number : 6430003

    Moscow, 115280

  • Investigational Site Number : 6430002

    Moscow, 125284

  • Investigational Site Number : 6430009

    Nizhny Novgorod, 603126

  • Investigational Site Number : 6430010

    Ryazan

  • Investigational Site Number : 6430004

    Saint Petersburg, 194354

  • Investigational Site Number : 6430013

    Saint Petersburg, 198328

  • Investigational Site Number : 6430014

    Saint Petersburg, 928260

  • Investigational Site Number : 6430012

    Stavropol, 355020

  • Investigational Site Number : 6430006

    Tomsk, 634034

  • Investigational Site Number : 6430008

    Ulyanovsk, 432017

  • Investigational Site Number : 6430005

    Voronezh, 394066

Other trials in Russia

Canada11 sites

  • Investigational Site Number : 1240010

    Ajax, Ontario, L1S 2J5

  • Investigational Site Number : 1240015

    Calgary, Alberta, T3L 3E6

  • Investigational Site Number : 1240018

    Kamloops, British Columbia, V2C 5T1

  • Investigational Site Number : 1240017

    Kelowna, British Columbia, V1Y 4N7

  • Investigational Site Number : 1240014

    Moncton, New Brunswick, E1G 5C4

  • Investigational Site Number : 1240004

    Montreal, Quebec, H3T 1E2

  • Investigational Site Number : 1240012

    Québec, Quebec, G1V 4W2

  • Investigational Site Number : 1240001

    Québec, G1G 3Y8

  • Investigational Site Number : 1240005

    Québec, G2J 0C4

  • Investigational Site Number : 1240009

    Sarnia, Ontario, N7T 4X3

  • Investigational Site Number : 1240007

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Mexico11 sites

  • Investigational Site Number : 4840008

    Benito Juárez, Mexico City, 03100

  • Investigational Site Number : 4840010

    Chihuahua City, 31000

  • Investigational Site Number : 4840006

    Durango, 34000

  • Investigational Site Number : 4840002

    Guadalajara, Jalisco, 44100

  • Investigational Site Number : 4840013

    Guadalajara, Jalisco, 44670

  • Investigational Site Number : 4840007

    Mexico City, 14050

  • Investigational Site Number : 4840009

    Mexico City, 67000

  • Investigational Site Number : 4840004

    Monterrey, Nuevo León, 64710

  • Investigational Site Number : 4840003

    Monterrey, Nuevo León, 66465

  • Investigational Site Number : 4840005

    Veracruz, 91910

  • Investigational Site Number : 4840011

    Zapopan, Jalisco, 45070

Other trials in Mexico

Poland11 sites

  • Investigational Site Number : 6160008

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number : 6160014

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Investigational Site Number : 6160015

    Grodzisk Mazowiecki, Masovian Voivodeship, 05-825

  • Investigational Site Number : 6160009

    Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300

  • Investigational Site Number : 6160018

    Katowice, Silesian Voivodeship, 40-611

  • Investigational Site Number : 6160011

    Katowice, Silesian Voivodeship, 40-648

  • Investigational Site Number : 6160007

    Krakow, Lesser Poland Voivodeship, 31-559

  • Investigational Site Number : 6160019

    Krakow, 30-033

  • Investigational Site Number : 6160020

    Nowa Sól, 67-100

  • Investigational Site Number : 6160022

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Investigational Site Number : 6160010

    Rzeszów, Podkarpackie Voivodeship, 35-205

Other trials in Poland

United Kingdom11 sites

  • Investigational Site Number : 8260012

    Aylesbury, HP218AL

  • Investigational Site Number : 8260002

    Blackpool, Lancashire, FY3 7DQ

  • Investigational Site Number : 8260001

    Bradford, BD9 6RJ

  • Investigational Site Number : 8260005

    Bristol, BS10 5NB

  • Investigational Site Number : 8260003

    Cambridge, Cambridgeshire, CB2 2QQ

  • Investigational Site Number : 8260011

    Chippenham, SN15 2SB

  • Investigational Site Number : 8260015

    Derby, DE223NE

  • Investigational Site Number : 8260007

    North Shields, Newcastle Upon Tyne, NE29 8NH

  • Investigational Site Number : 8260013

    Nottingham, Nottinghamshire, NG5 1PB

  • Investigational Site Number : 8260004

    South Shields, Newcastle Upon Tyne, NE34 0PL

  • Investigational Site Number : 8260006

    Swansea, Neath Port Talbot, SA2 8QA

Other trials in United Kingdom

Ukraine10 sites

  • Investigational Site Number : 8040011

    Chernivtsi, 58001

  • Investigational Site Number : 8040002

    Ivano-Frankivsk, 76018

  • Investigational Site Number : 8040003

    Ivano-Frankivsk, 76018

  • Investigational Site Number : 8040001

    Kharkiv, 61124

  • Investigational Site Number : 8040007

    Kyiv, 01033

  • Investigational Site Number : 8040004

    Kyiv, 03049

  • Investigational Site Number : 8040006

    Lviv, 79011

  • Investigational Site Number : 8040010

    Ternopil, 46000

  • Investigational Site Number : 8040008

    Zaporizhzhya, 69076

  • Investigational Site Number : 8040009

    Zaporizhzhya, 69600

Other trials in Ukraine

Netherlands9 sites

  • Investigational Site Number : 5280005

    Arnhem, 6815 AD

  • Investigational Site Number : 5280001

    Breda, 4818 CK

  • Investigational Site Number : 5280010

    Dordrecht, 3318 AT

  • Investigational Site Number : 5280009

    Harderwijk, 3844 DG

  • Investigational Site Number : 5280002

    Leeuwarden, 8934 AD

  • Investigational Site Number : 5280006

    Nijmegen, 6532 SZ

  • Investigational Site Number : 5280011

    Roermond, 6043 CV

  • Investigational Site Number : 5280008

    Zutphen, 7207 AE

  • Investigational Site Number : 5280004

    Zwolle, 8025 AB

Other trials in Netherlands

France8 sites

  • Investigational Site Number : 2500009

    Bayonne, 64100

  • Investigational Site Number : 2500002

    Dijon, 21079

  • Investigational Site Number : 2500005

    Lyon, 69004

  • Investigational Site Number : 2500003

    Montpellier, 34295

  • Investigational Site Number : 2500007

    Paris, 75014

  • Investigational Site Number : 2500008

    Paris, 75015

  • Investigational Site Number : 2500006

    Pessac, 33600

  • Investigational Site Number : 2500001

    Saint-Herblain, 44800

Other trials in France

Spain8 sites

  • Investigational Site Number : 7240009

    Badalona, Catalunya [Cataluña], 08916

  • Investigational Site Number : 7240002

    Barcelona, Barcelona [Barcelona], 08023

  • Investigational Site Number : 7240012

    Cáceres, Cáceres, 10002

  • Investigational Site Number : 7240003

    Madrid, Madrid, Comunidad de, 28046

  • Investigational Site Number : 7240010

    Málaga, 29010

  • Investigational Site Number : 7240007

    Oviedo, Principality of Asturias, 33011

  • Investigational Site Number : 7240008

    Valencia, Valenciana, Comunidad, 46017

  • Investigational Site Number : 7240011

    Zaragoza, 50009

Other trials in Spain

Chile7 sites

  • Investigational Site Number : 1520006

    Curicó, Maule Region, 3341643

  • Investigational Site Number : 1520004

    Quillota, Valparaiso, 2260877

  • Investigational Site Number : 1520007

    Santiago, Reg Metropolitana de Santiago, 7500571

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 8910131

  • Investigational Site Number : 1520001

    Talca, Maule Region

  • Investigational Site Number : 1520009

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Czechia7 sites

  • Investigational Site Number : 2030009

    Havlíčkův Brod, 580 01

  • Investigational Site Number : 2030004

    Jihlava, 58633

  • Investigational Site Number : 2030001

    Jindrichuv Hradec III, 37701

  • Investigational Site Number : 2030007

    Kralupy nad Vltavou, 278 01

  • Investigational Site Number : 2030003

    Miroslav, 67172

  • Investigational Site Number : 2030010

    Nymburk, 288 01

  • Investigational Site Number : 2030002

    Strakonice, 38601

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Latvia7 sites

  • Investigational Site Number : 4280008

    Balvi, LV-4501

  • Investigational Site Number : 4280007

    Rēzekne, LV - 4601

  • Investigational Site Number : 4280001

    Riga, LV -1010

  • Investigational Site Number : 4280005

    Riga, LV -1010

  • Investigational Site Number : 4280006

    Riga, LV -1021

  • Investigational Site Number : 4280002

    Riga, LV-1002

  • Investigational Site Number : 4280003

    Riga, LV-1038

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Greece6 sites

  • Investigational Site Number : 3000006

    Athens, 10675

  • Investigational Site Number : 3000001

    Athens, 11527

  • Investigational Site Number : 3000003

    Heraklion, 71500

  • Investigational Site Number : 3000002

    Ioannina, 455 00

  • Investigational Site Number : 3000007

    Palaio Faliro, Athens, 17562

  • Investigational Site Number : 3000004

    Thessaloniki, 57010

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Hungary6 sites

  • Investigational Site Number : 3480003

    Edelény, 3780

  • Investigational Site Number : 3480004

    Gödöllö, 2100

  • Investigational Site Number : 3480002

    Hajdunánás, 4080

  • Investigational Site Number : 3480006

    Mosonmagyaróvár, 9200

  • Investigational Site Number : 3480001

    Százhalombatta, 2440

  • Investigational Site Number : 3480005

    Szombathely, 9700

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Romania6 sites

  • Investigational Site Number : 6425004

    Bacau, 600252

  • Investigational Site Number : 6425003

    Cluj-Napoca, 400275

  • Investigational Site Number : 6425005

    Constanța, 900002

  • Investigational Site Number : 6425002

    Iași, 700732

  • Investigational Site Number : 6425006

    Piteşti, 110117

  • Investigational Site Number : 6425001

    Timișoara, 300134

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Serbia6 sites

  • Investigational Site Number : 6880005

    Belgrade, 11000

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    Belgrade, 11000

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    Belgrade, 11000

  • Investigational Site Number : 6880001

    Kamenitz, 21204

  • Investigational Site Number : 6880003

    Kragujevac, 34000

  • Investigational Site Number : 6880002

    Valjevo, 14000

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    Košice, 040 01

  • Investigational Site Number : 7030003

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    Spišská Nová Ves, 05201

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  • Investigational Site Number : 6200009

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  • Investigational Site Number : 6200012

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About this study

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

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

Read more
  • 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)
Read the detailed description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up

Being tested
Dupilumab SAR231893, Inhaled Corticosteroid, Inhaled Long-Acting Beta Agonist, Inhaled Long-Acting Muscarinic Antagonist, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab SAR231893Drug

    Also called Dupixent

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

  • Inhaled CorticosteroidDrug

    Pharmaceutical form: Inhaled Powder

    Route of administration: Oral inhalation

  • Inhaled Long-Acting Beta AgonistDrug

    Pharmaceutical form: Inhaled Powder

    Route of administration: Oral inhalation

  • Inhaled Long-Acting Muscarinic AntagonistDrug

    Pharmaceutical form: Inhaled Powder

    Route of administration: Oral inhalation

  • PlaceboDrug

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

Study groups in NCT04456673
Study groupRoleWhat they receive
DupilumabExperimentalParticipants received dupilumab 300 mg subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks
Receives: Drug: Dupilumab SAR231893; Drug: Inhaled Corticosteroid; Drug: Inhaled Long-Acting Beta Agonist; Drug: Inhaled Long-Acting Muscarinic Antagonist
PlaceboPlacebo comparatorParticipants received placebo matched to dupilumab 300 mg SC injection q2w up to 52 weeks
Receives: Drug: Inhaled Corticosteroid; Drug: Inhaled Long-Acting Beta Agonist; Drug: Inhaled Long-Acting Muscarinic Antagonist; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period

    Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for >24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.

    Measured: Baseline (Day 1) to Week 52

Secondary outcomes (14)

  1. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) to Week 12

    The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.

    Measured: Baseline (Day 1) and Week 12

  2. Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score to Week 52

    The SGRQ is a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation and rated on electronic diary. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had a unique empirically derived weight where lowest possible weight was 0 and the highest was 100. Total score was obtained by summing all positive responses in the questionnaire. The total score and domain score was derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating worse health status/health related quality of life. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.

    Measured: Baseline (Day 1) and Week 52

  3. Percentage of Participants With Saint George's Respiratory Questionnaire Improvement ≥4 Points at Week 52

    A responder was defined as a participant with improvement from baseline in SGRQ total score at Week 52 by ≥4 points. Percentage of participants who achieved a clinically meaningful response in SGRQ total score (improvement by ≥4 points)/responders are reported. SGRQ is a 50-item self-administered questionnaire. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had unique empirically derived weight where lowest possible weight was 0 and highest was 100. Total score was obtained by summing all positive responses in questionnaire. Total score and domain score was derived from relevant items and converted to a score of 0 to 100; higher score indicating worse health status/health related quality of life.

    Measured: Baseline (Day 1) and Week 52

  4. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Week 52

    The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.

    Measured: Baseline (Day 1) and Week 52

  5. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 24, 36, and 44

    The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.

    Measured: Baseline (Day 1) and Weeks 2, 4, 8, 24, 36 and 44

  6. Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 12, 24, 36, and 52

    The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 referred to the spirometry performed consistent with the mechanism of action of reliever (30 minutes for albuterol or another short-acting beta agonists). Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.

    Measured: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36 and 52

  7. Change From Baseline in Forced Expiratory Flow (FEF) 25 to 75 Percent (%) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52

    FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the FEF at 25% to 75% of forced vital capacity (FVC), where FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.

    Measured: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 44 and 52

  8. Annualized Rate of Severe Chronic Obstructive Pulmonary Disease Exacerbations Over the 52-week Treatment Period

    Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for >24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.

    Measured: Baseline (Day 1) to Week 52

  9. Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease Exacerbation Event During the 52-week Treatment Period

    The time to first moderate or severe exacerbation was defined as date of the first event minus randomization date +1. Moderate exacerbations were recorded by the Investigator and defined as AECOPD event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for >24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Median time as well as 95% confidence interval was calculated using Kaplan-Meier estimates.

    Measured: Baseline (Day 1) and up to Weeks 12, 24, 36 and 52

  10. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed or worsened or became serious during TE period (between the first administration of study treatment to the last administration of the study treatment + 98 days).

    Measured: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days

  11. Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology

    Blood samples were collected to determine PCSA in hematology. PCSA values were defined as abnormal values considered medically important by the Sponsor according to pre-defined criteria/thresholds based on literature review and defined by the Sponsor for clinical laboratory tests. Criteria for PCSA: Hemoglobin (Hb): ≤115 grams per liter (g/L) (Male[M]); ≤95 g/L (Female[F]), ≥185 g/L (M); ≥165 g/L (F), Decrease from baseline ≥20 g/L; Hematocrit: ≤0.37 volume per volume (v/v) (M); ≤0.32 v/v (F), ≥0.55 v/v (M); ≥0.5 v/v (F); Erythrocyte Count: ≥6 Tera/L; Platelet count: <100 Giga/L, ≥700 Giga/L; Leukocytes: <3 Giga/L (Non-Black [NB]); <2 Giga/L (Black [B]), ≥16 Giga/L; Neutrophils: <1.5 Giga/L (NB); <1 Giga/L (B); Lymphocytes: >4 Giga/L; Monocytes: >0.7 Giga/L; Basophils: >0.1 Giga/L; Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN ≥0.5 Giga/L).

    Measured: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days

  12. Percentage of Participants With Potentially Clinically Significant Abnormalities in Clinical Chemistry

    Blood samples were collected to determine PCSA in chemistry. PCSA criteria: Sodium: ≤129 millimoles (mmol)/L, ≥160 mmol/L; Potassium: <3 mmol/L, ≥5.5 mmol/L; Chloride: <80 mmol/L, >115 mmol/L; Glucose: ≤3.9 mmol/L and <lower limit of normal (LLN), ≥11.1 mmol/L (unfasted); ≥7 mmol/L (fasted);Total cholesterol: ≥7.74 mmol/L; Creatinine kinase: >3 ULN, >10 ULN; Creatinine: ≥150 micromoles (µmol)/L (adults), ≥30% change from baseline, ≥100% change from baseline, Creatinine Clearance (CG): ≥60 - <90 milliliter per minute (mL/min), ≥30 - <60 mL/min, ≥15 - <30 mL/min, <15 mL/min; Urea nitrogen: ≥17 mmol/L; Uric acid: <120 μmol/L, >408 μmol/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST): >3 ULN, >5 ULN, >10 ULN; Alkaline phosphatase (ALP): >1.5 ULN; Total bilirubin (TB): >1.5 ULN, >2 ULN; ALT and TB: ALT >3 ULN and Bilirubin > 2 ULN; Direct bilirubin (DB) and TB: DB >35% Bilirubin and Bilirubin >1.5 ULN; Albumin: ≤25 g/L.

    Measured: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days

  13. Percentage of Participants With Abnormal Results for Urine Protein in Urinalysis

    Urine dipstick samples were collected to determine the significant abnormalities in urine protein.

    Measured: Baseline (Day 1), Weeks 4, 8, 12, 24, 36, 52 and 64

  14. Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab

    Plasma samples were collected to evaluate antibodies to dupilumab. Pre-existing immunoreactivity is defined as an ADA positive response in the assay at baseline with all post-treatment ADA results negative, or an ADA positive response at baseline with all post-treatment ADA responses less than 4-fold over baseline titer levels. Treatment-emergent response is defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. Treatment-boosted response is defined as an ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2020
  2. Study start6 Jul 2020
  3. Primary completion28 Feb 2024
  4. Study completion27 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
935 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04456673
Sponsor's protocol ID
EFC15805
Other IDs
U1111-1211-8837, 2018-001954-91, 2018
Acronym
NOTUS
Status last verified
May 2025
First submitted
30 Jun 2020
Last updated
29 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Walsh L, Winders T, Bansal A, Robinson LB. Summary of Research: Dupilumab for Chronic Obstructive Pulmonary Disease with Type 2 Inflammation: A Pooled Analysis of Two Phase 3, Randomised, Double-Blind, Placebo-Controlled Trials. Pulm Ther. 2026 Jun 23. doi: 10.1007/s41030-026-00361-2. Online ahead of print.

    PubMed 42337097

  • Bhatt SP, Martinez FJ, Satia I, Anzueto A, Bourbeau J, Papi A, Korn S, Deslee G, Xia C, Heble J, Soliman M, Bafadhel M. Dupilumab in chronic obstructive pulmonary disease: a pooled analysis of emergency department visits, hospital admissions, and systemic corticosteroid use. Am J Respir Crit Care Med. 2026 Sep 1;212(9):2011-2021. doi: 10.1093/ajrccm/aamag227.

    PubMed 42153327

  • Ramakrishnan S, Petousi N, Bon J, Pavord ID, Bhatt SP, Rabe KF, Deng W, Xia C, Heble J, Soliman M, Couillard S. Win Ratio Analysis to Clarify Clinical Benefits: A Post Hoc Analysis of Phase 3 BOREAS and NOTUS (Two Pivotal Studies to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-Severe COPD With Type 2 Inflammation). Chest. 2026 Jul;170(1):76-87. doi: 10.1016/j.chest.2026.02.005. Epub 2026 Mar 5.

    PubMed 41794122

  • 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.

    PubMed 39894389

  • 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.

    PubMed 38767614

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab SAR231893, Inhaled Corticosteroid and Inhaled Long-Acting Beta Agonist in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 334 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 334 sites in United States, Bulgaria, Germany, Brazil, South Africa and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period (time frame: Baseline (Day 1) to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04456673, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.

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