AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3BOREASNCT03930732

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 275 sites in 24 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 and severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab… Read more about this study

Who is it for?
Ages 40 to 80 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
939 participants
Where
275 sitesin 24 countries
Study dates
15 Apr 2019to 2 May 2023
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 80 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 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 were recorded by the investigator and defined as acute exacerbation of COPD (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 was contraindicated.
  • Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.

Who cannot join

  • COPD diagnosis for less than 12 months prior to randomization.
  • A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
  • Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
  • Cor pulmonale, evidence of right cardiac failure.
  • Treatment with oxygen of more than 12 hours per day.
  • Hypercapnia requiring Bi-level ventilation.
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. Patients who were 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 could be included).
  • Diagnosis of α-1 anti-trypsin deficiency.
  • The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

275 sites in 24 countries.

275 sites in 24 countries

United States51 sites

  • SEC Clinical Research, LLC-Site Number:8400030

    Andalusia, Alabama, 36420

  • Michigan Medicine (University of Michigan)-Site Number:8400050

    Ann Arbor, Michigan, 48109

  • Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012

    Baltimore, Maryland, 21224

  • Clinical Research Center of Alabama, LLC-Site Number:8400041

    Birmingham, Alabama, 35209-6802

  • UAB Lung Health Center-Site Number:8400013

    Birmingham, Alabama, 35294

  • Va Western New York Healthcare-Site Number:8400067

    Buffalo, New York, 14215

  • The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019

    Chapel Hill, North Carolina, 27514

  • American Health Research-Site Number:8400061

    Charlotte, North Carolina, 28277

  • Jefferson Associates in Internal Medicine-Site Number:8400037

    Clairton, Pennsylvania, 15025

  • Clinical Research Of West Florida Inc-Site Number:8400010

    Clearwater, Florida, 33765

  • Asthma and Allergy Associates, PC-Site Number:8400034

    Colorado Springs, Colorado, 80907

  • VitaLink research-Hamilton Mill-Site Number:8400055

    Dacula, Georgia, 30019

  • Midwest Pulmonary and Sleep Research Center-Site Number:8400040

    Dayton, Ohio, 45459

  • SEC Clinical Research, LLC-Site Number:8400059

    Dothan, Alabama, 36303

  • Aventiv Research, Inc-Site Number:8400024

    Dublin, Ohio, 43016

  • Duke Asthma, Allergy and Airway Center-Site Number:8400064

    Durham, North Carolina, 27705

  • VitaLink Research-Easley-Site Number:8400022

    Easley, South Carolina, 29640

  • OK Clinical Research-Site Number:8400005

    Edmond, Oklahoma, 73034

  • Clinical Trials Center of Middle Tennessee-Site Number:8400073

    Franklin, Tennessee, 37067

  • VitaLink Research- Gaffney-Site Number:8400047

    Gaffney, South Carolina, 29340

  • Finlay Medical Research-Site Number:8400014

    Greenacres City, Florida, 33467

  • Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008

    Greenfield, Wisconsin, 53228

  • VitaLink Research-Greenville-Site Number:8400007

    Greenville, South Carolina, 29615

  • Bayer College of Medicine-Site Number:8400018

    Houston, Texas, 77030

  • Sierra Clinical Research-Site Number:8400035

    Las Vegas, Nevada, 89106

  • DC Research Works-Site Number:8400016

    Marietta, Georgia, 30060

  • Metroplex Pulmonary and Sleep Center-Site Number:8400021

    McKinney, Texas, 75069

  • Velocity Clinical Research, Medford-Site Number:8400001

    Medford, Oregon, 97504

  • Project 4 research, Inc.-Site Number:8400023

    Miami, Florida, 33125

  • Finlay Medical Research-Site Number:8400062

    Miami, Florida, 33126

  • Pulmonary Associates of Mobile, P.C.-Site Number:8400057

    Mobile, Alabama, 36608

  • Clinical Research of Charleston-Site Number:8400044

    Mt. Pleasant, South Carolina, 29464

  • IMA Clinical Research, LLC-Site Number:8400070

    New York, New York, 10036

  • Renstar Medical Research-Site Number:8400051

    Ocala, Florida, 34470

  • Florida Institute for Clinical Research, LLC-Site Number:8400029

    Orlando, Florida, 32825

  • Emerald Coast Research Associates-Site Number:8400032

    Panama City, Florida, 32405

  • Temple University Hospital-Site Number:8400009

    Philadelphia, Pennsylvania, 19140

  • Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic Lanmark Center 2-46-Site Number:8400065

    Rochester, Minnesota, 55905

  • Clinical Research of Rock Hill-Site Number:8400046

    Rock Hill, South Carolina, 29732

  • Midwest Chest Consultants, P.C.-Site Number:8400011

    Saint Charles, Missouri, 63301

  • Sarasota Clinical Research-Site Number:8400026

    Sarasota, Florida, 34239

  • Sherman Clinical Research-Site Number:8400027

    Sherman, Texas, 75092

  • VitaLink Research - Spartanburg-Site Number:8400048

    Spartanburg, South Carolina, 29303

  • Washington University School of Medicine-Site Number:8400004

    St Louis, Missouri, 63104

  • MultiCare Institute for Research and Innovation-Site Number:8400036

    Tacoma, Washington, 98405

  • Asthma Allergy & Sinus Center-Site Number:8400038

    White Marsh, Maryland, 21162

  • Accellacare-Site Number:8400052

    Wilmington, North Carolina, 28401

  • Southeastern Research Center-Site Number:8400060

    Winston-Salem, North Carolina, 27103-4027

  • North Georgia Clinical Research-Site Number:8400025

    Woodstock, Georgia, 30189

  • Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063

    Wyomissing, Pennsylvania, 19610

Other trials in United States

China37 sites

  • Investigational Site Number :1560037

    Baotou, 014010

  • Investigational Site Number :1560006

    Beijing

  • Investigational Site Number :1560003

    Changchun, 130021

  • Investigational Site Number :1560022

    Changsha, 410011

  • Investigational Site Number :1560021

    Changsha, 410013

  • Investigational Site Number :1560001

    Chengdu, 610041

  • Investigational Site Number :1560017

    Chengdu, 611130

  • Investigational Site Number :1560012

    Chongqing, 400037

  • Investigational Site Number :1560005

    Chongqing, 400038

  • Investigational Site Number :1560053

    Fuzhou, 350001

  • Investigational Site Number :1560036

    Guangzhou, 510150

  • Investigational Site Number :1560019

    Guangzhou, 510163

  • Investigational Site Number :1560045

    Haikou, 570216

  • Investigational Site Number :1560018

    Haikou, 570311

  • Investigational Site Number :1560046

    Hangzhou, 310009

  • Investigational Site Number :1560009

    Hefei, 230022

  • Investigational Site Number :1560041

    Hefei

  • Investigational Site Number :1560015

    Hohhot, 010017

  • Investigational Site Number :1560008

    Hohhot, 010050

  • Investigational Site Number :1560027

    Nanchang, 330006

  • Investigational Site Number :1560034

    Nanjing, 210009

  • Investigational Site Number :1560032

    Shanghai, 200025

  • Investigational Site Number :1560013

    Shanghai, 200080

  • Investigational Site Number :1560007

    Shanghai, 200433

  • Investigational Site Number :1560014

    Shenyang, 110001

  • Investigational Site Number :1560004

    Shenyang, 110004

  • Investigational Site Number :1560051

    Shenzhen, 518020

  • Investigational Site Number :1560016

    Shijiazhuang, 050000

  • Investigational Site Number :1560024

    Taiyuan, 030001

  • Investigational Site Number :1560010

    Tianjin, 300052

  • Investigational Site Number :1560028

    Ürümqi, 830054

  • Investigational Site Number :1560052

    Wuhan, 430014

  • Investigational Site Number :1560020

    Xi'an, 710061

  • Investigational Site Number :1560054

    Xuzhou, 221002

  • Investigational Site Number :1560011

    Yangzhou, 225001

  • Investigational Site Number :1560031

    Zhanjiang, 524001

  • Investigational Site Number :1560002

    Zhengzhou, 450003

Other trials in China

Japan22 sites

  • Investigational Site Number :3920008

    Chuo-ku, Tokyo, 103-0022

  • Investigational Site Number :3920030

    Chuo-ku, Tokyo, 103-0028

  • Investigational Site Number :3920005

    Chuo-ku, Tokyo, 104-0031

  • Investigational Site Number :3920021

    Hamamatsu, Shizuoka, 434-8511

  • Investigational Site Number :3920023

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Investigational Site Number :3920011

    Himeji-shi, Hyōgo, 670-0849

  • Investigational Site Number :3920003

    Joyo-shi, Kyoto, 610-0113

  • Investigational Site Number :3920013

    Kasuga-shi, Fukuoka, 816-0813

  • Investigational Site Number :3920018

    Kawachinagano-shi, Osaka, 586-8521

  • Investigational Site Number :3920001

    Kishiwada-shi, Osaka, 596-8501

  • Investigational Site Number :3920015

    Kokubunji-shi, Tokyo, 185-0014

  • Investigational Site Number :3920017

    Kyoto, Kyoto, 612-8555

  • Investigational Site Number :3920014

    Naka-gun, Ibaraki, 319-1113

  • Investigational Site Number :3920028

    Osaka, Osaka, 531-0073

  • Investigational Site Number :3920012

    Sakai-shi, Osaka, 591-8555

  • Investigational Site Number :3920016

    Shinagawa-ku, Tokyo, 140-8522

  • Investigational Site Number :3920019

    Takamatsu, Kagawa-ken, 761-8073

  • Investigational Site Number :3920004

    Toshima-ku, Tokyo, 170-0003

  • Investigational Site Number :3920026

    Toshima-ku, Tokyo, 1710014

  • Investigational Site Number :3920006

    Ueda-shi, Nagano

  • Investigational Site Number :3920029

    Urasoe-shi, Okinawa, 901-2121

  • Investigational Site Number :3920027

    Yokohama, Kanagawa, 223-0059

Other trials in Japan

Canada20 sites

  • Investigational Site Number :1240002

    Burlington, Ontario, L7N 3V2

  • Investigational Site Number :1240021

    Edmonton, Alberta, T5H4B9

  • Investigational Site Number :1240015

    Edmonton, Alberta, T6G 2G3

  • Investigational Site Number :1240009

    Montreal, Quebec, H1M 1B1

  • Investigational Site Number :1240003

    Montreal, Quebec, H1T 1C8

  • Investigational Site Number :1240001

    Montreal, Quebec, H4A 3J1

  • Investigational Site Number :1240005

    Québec, G1V 4G5

  • Investigational Site Number :1240004

    Québec, G1V 4W2

  • Investigational Site Number :1240019

    Québec, G3K 2P8

  • Investigational Site Number :1240018

    Québec, GIS 2L6

  • Investigational Site Number :1240010

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number :1240011

    Sherbrooke, Quebec, J1L 0H8

  • Investigational Site Number :1240016

    Sherwood Park, Alberta, T8H 0N2

  • Investigational Site Number :1240006

    St-charles Borrommee, Quebec, J6E 2B4

  • Investigational Site Number :1240012

    Toronto, Ontario, M5T 3A9

  • Investigational Site Number :1240008

    Trois-Rivières, Quebec, G8T 7A1

  • Investigational Site Number :1240017

    Vancouver, British Columbia, V5Z 1M9

  • Investigational Site Number :1240007

    Vancouver, British Columbia, V6Z 1Y6

  • Investigational Site Number :1240020

    Victoriaville, Quebec, G6P 6P6

  • Investigational Site Number :1240013

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Argentina12 sites

  • Investigational Site Number :0320001

    Buenos Aires, C1121ABE

  • Investigational Site Number :0320005

    Buenos Aires

  • Investigational Site Number :0320011

    CABA, Buenos Aires, 1430

  • Investigational Site Number :0320002

    CABA, Buenos Aires, C1414AIF

  • Investigational Site Number :0320003

    CABA, Buenos Aires, C1425BEN

  • Investigational Site Number :0320004

    CABA, Buenos Aires, C1425FVH

  • Investigational Site Number :0320012

    La Plata, Buenos Aires, B1900BNN

  • Investigational Site Number :0320008

    Mar del Plata, B7600

  • Investigational Site Number :0320010

    Mendoza, 5500

  • Investigational Site Number :0320007

    Quilmes, Buenos Aires F.D., B1878FNR

  • Investigational Site Number :0320006

    Rosario, Santa Fe Province, S2000DBS

  • Investigational Site Number :0320009

    San Miguel de Tucumán, Tucumán Province, T4000IAR

Other trials in Argentina

Hungary11 sites

  • Investigational Site Number :3480007

    Balassagyarmat, 2660

  • Investigational Site Number :3480011

    Budapest, 1122

  • Investigational Site Number :3480008

    Edelény, 3780

  • Investigational Site Number :3480001

    Gödöllö, 2100

  • Investigational Site Number :3480010

    Hajdunánás, 4080

  • Investigational Site Number :3480002

    Komárom, 2900

  • Investigational Site Number :3480003

    Makó, 6900

  • Investigational Site Number :3480006

    Mohács, 7700

  • Investigational Site Number :3480012

    Püspökladány, 4150

  • Investigational Site Number :3480004

    Százhalombatta, 2440

  • Investigational Site Number :3480005

    Szombathely, 9700

Other trials in Hungary

Poland9 sites

  • Investigational Site Number :6160008

    Bialystok, Podlaskie Voivodeship, 15-044

  • Investigational Site Number :6160014

    Elblag, Pomeranian 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 :6160011

    Katowice, Silesian Voivodeship, 40-648

  • Investigational Site Number :6160007

    Krakow, Lesser Poland Voivodeship, 31-559

  • Investigational Site Number :6160016

    Poznan, Greater Poland Voivodeship, 60-214

  • Investigational Site Number :6160006

    Poznan, Greater Poland Voivodeship, 61-578

  • Investigational Site Number :6160012

    Warsaw, Masovian Voivodeship, 01-456

Other trials in Poland

Russia9 sites

  • Investigational Site Number :6430003

    Chelyabinsk, 454091

  • Investigational Site Number :6430004

    Kazan', 420008

  • Investigational Site Number :6430006

    Moscow, 105077

  • Investigational Site Number :6430001

    Moscow, 115093

  • Investigational Site Number :6430005

    Moscow, 115280

  • Investigational Site Number :6430008

    Moscow, 115682

  • Investigational Site Number :6430002

    Moscow, 117546

  • Investigational Site Number :6430009

    Moscow, 125284

  • Investigational Site Number :6430007

    Saint Petersburg, 193231

Other trials in Russia

Spain9 sites

  • Investigational Site Number :7240002

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number :7240003

    Madrid, 28007

  • Investigational Site Number :7240001

    Málaga, 29010

  • Investigational Site Number :7240005

    Mérida / Badajoz, Extremadura, 06800

  • Investigational Site Number :7240010

    Palma de Mallorca, 07120

  • Investigational Site Number :7240006

    Pozuelo de Alarcón, Madrid, 28223

  • Investigational Site Number :7240007

    Sant Boi de Llobregat, Barcelona [Barcelona], 08830

  • Investigational Site Number :7240096

    Santiago de Compostela, A Coruña [La Coruña], 15706

  • Investigational Site Number :7240004

    Valencia, 46015

Other trials in Spain

Bulgaria8 sites

  • Investigational Site Number :1001004

    Haskovo, 6305

  • Investigational Site Number :1001003

    Montana, 3400

  • Investigational Site Number :1001006

    Rousse, 7002

  • Investigational Site Number :1001009

    Sofia, 1202

  • Investigational Site Number :1001002

    Sofia, 1233

  • Investigational Site Number :1001001

    Sofia, 1680

  • Investigational Site Number :1001005

    Stara Zagora, 6001

  • Investigational Site Number :1001010

    Troyan Municipality, 5600

Other trials in Bulgaria

Chile8 sites

  • Investigational Site Number :1520006

    Curicó, Maule Region, 3341643

  • Investigational Site Number :1520004

    Quillota, Valparaiso, 2260877

  • Investigational Site Number :1520009

    Santiago, Reg Metropolitana de Santiago, 7500587

  • Investigational Site Number :1520003

    Santiago, Reg Metropolitana de Santiago, 7500692

  • Investigational Site Number :1520005

    Santiago, Reg Metropolitana de Santiago, 7500698

  • Investigational Site Number :1520008

    Santiago, Reg Metropolitana de Santiago, 8380453

  • Investigational Site Number :1520002

    Santiago, Reg Metropolitana de Santiago, 8910131

  • Investigational Site Number :1520001

    Talca, Maule Region

Other trials in Chile

Czechia8 sites

  • Investigational Site Number :2030002

    Jindrichuv Hradec III, 37701

  • Investigational Site Number :2030005

    Karlovy Vary, 36017

  • Investigational Site Number :2030009

    Miroslav, 67172

  • Investigational Site Number :2030001

    Nový Bor, 47301

  • Investigational Site Number :2030003

    Prague, 14059

  • Investigational Site Number :2030008

    Praha 6 - Brevnov, 16900

  • Investigational Site Number :2030004

    Rokycany, 33722

  • Investigational Site Number :2030006

    Strakonice, 38601

Other trials in Czechia

Romania8 sites

  • Investigational Site Number :6420001

    Bucharest, 011461

  • Investigational Site Number :6420009

    Bucharest, 030303

  • Investigational Site Number :6420008

    Bucharest, 050159

  • Investigational Site Number :6420003

    Cluj-Napoca, 400371

  • Investigational Site Number :6420004

    Cluj-Napoca, 400371

  • Investigational Site Number :6420007

    Constanța, 900002

  • Investigational Site Number :6420006

    Timișoara, 300310

  • Investigational Site Number :6420010

    Timișoara, 300310

Other trials in Romania

Ukraine8 sites

  • Investigational Site Number :8040003

    Chernivtsi, 58001

  • Investigational Site Number :8040001

    Ivano-Frankivsk, 76018

  • Investigational Site Number :8040006

    Kharkiv, 61166

  • Investigational Site Number :8040004

    Kyiv, 02125

  • Investigational Site Number :8040009

    Odesa, 65025

  • Investigational Site Number :8040002

    Ternopil, 46000

  • Investigational Site Number :8040005

    Vinnytsia, 21001

  • Investigational Site Number :8040007

    Zhytomyr, 10002

Other trials in Ukraine

Denmark7 sites

  • Investigational Site Number :2080003

    Aalborg, 9100

  • Investigational Site Number :2080001

    Copenhagen Nv, 2400

  • Investigational Site Number :2080002

    Hvidovre, 2650

  • Investigational Site Number :2080006

    Næstved, 4700

  • Investigational Site Number :2080005

    Odense C, 5000

  • Investigational Site Number :2080004

    Roskilde, 4000

  • Investigational Site Number :2080007

    Vejle, 7100

Other trials in Denmark

Germany7 sites

  • Investigational Site Number :2760006

    Berlin, 10787

  • Investigational Site Number :2760009

    Frankfurt am Main, 60596

  • Investigational Site Number :2760002

    Hamburg, 20354

  • Investigational Site Number :2760007

    Koblenz, 56068

  • Investigational Site Number :2760011

    Leipzig, 04347

  • Investigational Site Number :2760010

    Lübeck, 23552

  • Investigational Site Number :2760008

    Marburg, 35043

Other trials in Germany

Israel7 sites

  • Investigational Site Number :3760006

    Ashkelon, 78278

  • Investigational Site Number :3760007

    Beersheba, 84101

  • Investigational Site Number :3760003

    Haifa, 34362

  • Investigational Site Number :3760005

    Jerusalem, 91031

  • Investigational Site Number :3760004

    Jerusalem, 91120

  • Investigational Site Number :3760001

    Petah Tikva, 49100

  • Investigational Site Number :3760002

    Rehovot, 76100

Other trials in Israel

Mexico7 sites

  • Investigational Site Number :4840004

    Chihuahua City, 31000

  • Investigational Site Number :4840003

    Durango, 34080

  • Investigational Site Number :4840002

    Guadalajara, Jalisco, 44100

  • Investigational Site Number :4840006

    Mexico City, 06700

  • Investigational Site Number :4840001

    Monterrey, Nuevo León, 64460

  • Investigational Site Number :4840007

    Oaxaca City, 68000

  • Investigational Site Number :4840005

    Veracruz, 91910

Other trials in Mexico

Turkey (Türkiye)7 sites

  • Investigational Site Number :7920004

    Ankara, 06100

  • Investigational Site Number :7920001

    Istanbul, 34098

  • Investigational Site Number :7920006

    Izmir, 35040

  • Investigational Site Number :7920007

    Izmir, 35110

  • Investigational Site Number :7920008

    Kirikkale, 71450

  • Investigational Site Number :7920005

    Manisa, 45000

  • Investigational Site Number :7920002

    Mersin, 33070

Other trials in Turkey (Türkiye)

South Korea6 sites

  • Investigational Site Number :4100008

    Incheon, Incheon-gwangyeoksi, 21431

  • Investigational Site Number :4100004

    Seongnam-si, Gyeonggi-do, 13620

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 03080

  • Investigational Site Number :4100009

    Seoul, Seoul-teukbyeolsi, 03312

  • Investigational Site Number :4100007

    Seoul, Seoul-teukbyeolsi, 05505

  • Investigational Site Number :4100003

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Italy5 sites

  • Investigational Site Number :3800004

    Cona, Ferrara, 44124

  • Investigational Site Number :3800007

    Pisa, 56124

  • Investigational Site Number :3800001

    Reggio Emilia, 42123

  • Investigational Site Number :3800005

    Roma, 00133

  • Investigational Site Number :3800003

    Rozzano, Milano, 20089

Other trials in Italy

Slovakia5 sites

  • Investigational Site Number :7030007

    Banská Bystrica, 97517

  • Investigational Site Number :7030006

    Humenné, 066 01

  • Investigational Site Number :7030003

    Levice, 93401

  • Investigational Site Number :7030001

    Poprad, 058 01

  • Investigational Site Number :7030002

    Spišská Nová Ves, 05201

Other trials in Slovakia

Finland2 sites

  • Investigational Site Number :2460003

    Pori, 28500

  • Investigational Site Number :2460001

    Turku, 20520

Other trials in Finland

Sweden2 sites

  • Investigational Site Number :7520001

    Lund, 221 85

  • Investigational Site Number :7520002

    Stockholm, 114 46

Other trials in Sweden

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

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  • Annualized rate of acute moderate and severe COPD exacerbation (AECOPD)

Secondary Objectives:

To evaluate the effect of dupilumab administered every 2 weeks on

  • Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo
  • Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)
  • Pre-bronchodilator FEV1 over 52 weeks compared to placebo
  • Lung function assessments
  • Moderate and severe COPD exacerbations
  • To evaluate safety and tolerability
  • To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)
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 NCT03930732
Study groupRoleWhat they receive
DupilumabExperimentalParticipants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).
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 as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment [EOT] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).
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) 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.

    Measured: Baseline (Day 1) to Week 52

Secondary outcomes (16)

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

    The FEV1 was 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.

    Measured: Baseline (Day 1) to Week 12

  2. Change From Baseline in Pre-BD FEV1 at Week 52

    The FEV1 was 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.

    Measured: Baseline (Day 1) to Week 52

  3. Change From Baseline in Pre-BD FEV1 at Week 12 in Subgroup of Participants With Baseline Fractional Exhaled Nitric Oxide (FeNO) >=20 Parts Per Billion (Ppb)

    FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second (mL/s) and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour.

    Measured: Baseline (Day 1) to Week 12

  4. Change From Baseline in Pre-BD FEV1 at Week 52 in Subgroup of Participants With Baseline FeNO >=20 Ppb

    FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour.

    Measured: Baseline (Day 1) to Week 52

  5. Change From Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

    The SGRQ was 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, activity and impacts (psycho-social) as well as a total score. Global and domain scores range from 0 to 100, with 100 representing the worst possible health status and 0 indicating the best possible health status. Higher score indicates worse health status/heath related quality of life.

    Measured: Baseline (Day 1) to Week 52

  6. Percentage of Participants With SGRQ 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. Participants with improvement <4 points or with missing values were considered as non-responders. The percentage of participants who achieved a clinically meaningful response in SGRQ total score (reduction [improvement] by >=4 points)/responders are reported.

    Measured: Baseline (Day 1) to Week 52

  7. Change From Baseline in Evaluating Respiratory Symptoms (E-RS) in COPD (E-RS: COPD) RS-Total Score at Week 52

    The E-RS in COPD scale was a part of the exacerbations of chronic pulmonary disease tool (EXACT). It was a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. E-RS: COPD RS-Total Score was derived based on weekly averages of daily assessed 11 respiratory symptom items contained in the 14-item EXACT questionnaire. The RS-Total score represented overall respiratory symptom severity, ranged from 0 to 40. Summation procedure was used to derive the three daily domain scores: 1). RS-Breathlessness (range 0-17), 2) RS-Cough and Sputum (score range 0-11), 3) RS-Chest Symptoms (score range 0-12). The higher the score, more severe were the symptoms.

    Measured: Baseline (Day 1) to Week 52

  8. Annualized Rate of Moderate or Severe COPD Exacerbation Over the 52-Week Treatment Period in Subgroup of Participants With Baseline FeNO >=20 Ppb

    Moderate exacerbations were recorded by the Investigator and defined as AECOPD 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 among participants with baseline FeNO >=20 ppb was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.

    Measured: Baseline (Day 1) to Week 52

  9. Change From Baseline in Pre-BD FEV1 to Weeks 2, 4, 8, 24, 36 and 44

    The FEV1 was 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.

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

  10. Change From Baseline in Post-BD FEV1 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-BD FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator.

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

  11. Change From Baseline in Pre-BD Forced Expiratory Flow at 25 Percent (%) to 75% (FEF 25-75%) of Forced Vital Capacity (FVC) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52

    FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) 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.

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

  12. Change From Baseline in Post-BD FEF 25-75% to Weeks 2, 4, 8, 12, 24, 36 and 52

    FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) 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.

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

  13. Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period

    Moderate exacerbations were recorded by the Investigator and defined as AECOPD 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party.

    Measured: Baseline (Day 1) to Week 52

  14. Time to First Moderate or Severe COPD Exacerbation 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. The median time to first severe exacerbation was derived from Cox regression model. Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days.

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

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

    An Adverse Event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TE period which was defined as the period from the time of first dose of study treatment until the last visit in the study. Serious adverse events (SAE) were 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 or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

    Measured: TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days

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

    Number of participants with treatment-emergent response to dupilumab with peak post-baseline titers during the on-treatment period are reported. Treatment-emergent response was defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Categories were based on titer values and included: low (Titer <1000); moderate (1000<=Titer<=10,000); and high (Titer >10,000). On-treatment period was defined as last study treatment administration plus 14 days; that is, Week 52.

    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 posted29 Apr 2019
  2. Study start15 Apr 2019
  3. Primary completion8 Feb 2023
  4. Study completion2 May 2023

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
939 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03930732
Sponsor's protocol ID
EFC15804
Other IDs
2018-001953-28, U1111-1211-8804, 2018
Acronym
BOREAS
Status last verified
Jan 2024
First submitted
26 Apr 2019
Last updated
28 Feb 2024
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

  • Christenson SA, Hanania NA, Bhatt SP, Bafadhel M, Rabe KF, Vogelmeier CF, Papi A, Singh D, Laws E, Dakin P, Bansal A, Lu X, Bauer D, Maloney J, Robinson LB, Abdulai RM. Type 2 inflammation biomarkers and their association with response to dupilumab in COPD (BOREAS): an analysis of a randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2025 Aug;13(8):687-697. doi: 10.1016/S2213-2600(25)00044-X. Epub 2025 Jul 9.

    PubMed 40651490

  • Vogelmeier CF, Rabe KF, Bhatt SP, Hanania NA, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Maloney J, Dakin P, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces acute exacerbations and improves lung function in patients with COPD with type 2 inflammation irrespective of body mass index, airflow obstruction, dyspnea, and exercise capacity index scores. Respir Med. 2025 May;241:108015. doi: 10.1016/j.rmed.2025.108015. Epub 2025 Feb 28.

    PubMed 40024335

  • 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, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema: Phase 3 randomized trial (BOREAS). Respir Med. 2025 Jan;236:107846. doi: 10.1016/j.rmed.2024.107846. Epub 2024 Oct 30.

    PubMed 39481660

  • Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Cole J, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Mannent LP, Patel N, Staudinger HW, Yancopoulos GD, Mortensen ER, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM; BOREAS Investigators. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214. doi: 10.1056/NEJMoa2303951. Epub 2023 May 21.

    PubMed 37272521

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 275 sites in 24 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 275 sites in United States, China, Japan, Canada, Argentina and 19 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 28 Feb 2024). 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 NCT03930732, which also lists 8 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 28 Feb 2024.

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