Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
NCT ID: NCT03930732
Last Updated: 2024-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
939 participants
INTERVENTIONAL
2019-04-15
2023-05-02
Brief Summary
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To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by
* Annualized rate of acute moderate 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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dupilumab
Participants received dupilumab 300 mg 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).
Dupilumab SAR231893
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Placebo
Participants received placebo matched to dupilumab 300 mg 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).
Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Placebo
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Interventions
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Dupilumab SAR231893
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Placebo
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current or former smokers with a smoking history of ≥10 pack-years.
* Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity \[FVC\] ratio \<0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%).
* Medical Research Council (MRC) Dyspnea Scale grade ≥2.
* Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
* Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the 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.
* 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.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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VitaLink Research-Easley-Site Number:8400022
Easley, South Carolina, United States
SEC Clinical Research, LLC-Site Number:8400030
Andalusia, Alabama, United States
Clinical Research Center of Alabama, LLC-Site Number:8400041
Birmingham, Alabama, United States
UAB Lung Health Center-Site Number:8400013
Birmingham, Alabama, United States
SEC Clinical Research, LLC-Site Number:8400059
Dothan, Alabama, United States
Pulmonary Associates of Mobile, P.C.-Site Number:8400057
Mobile, Alabama, United States
Asthma and Allergy Associates, PC-Site Number:8400034
Colorado Springs, Colorado, United States
Clinical Research Of West Florida Inc-Site Number:8400010
Clearwater, Florida, United States
Finlay Medical Research-Site Number:8400014
Greenacres City, Florida, United States
Project 4 research, Inc.-Site Number:8400023
Miami, Florida, United States
Finlay Medical Research-Site Number:8400062
Miami, Florida, United States
Renstar Medical Research-Site Number:8400051
Ocala, Florida, United States
Florida Institute for Clinical Research, LLC-Site Number:8400029
Orlando, Florida, United States
Emerald Coast Research Associates-Site Number:8400032
Panama City, Florida, United States
Sarasota Clinical Research-Site Number:8400026
Sarasota, Florida, United States
VitaLink research-Hamilton Mill-Site Number:8400055
Dacula, Georgia, United States
DC Research Works-Site Number:8400016
Marietta, Georgia, United States
North Georgia Clinical Research-Site Number:8400025
Woodstock, Georgia, United States
Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012
Baltimore, Maryland, United States
Asthma Allergy & Sinus Center-Site Number:8400038
White Marsh, Maryland, United States
Michigan Medicine (University of Michigan)-Site Number:8400050
Ann Arbor, Michigan, United States
Mayo Clinic Lanmark Center 2-46-Site Number:8400065
Rochester, Minnesota, United States
Midwest Chest Consultants, P.C.-Site Number:8400011
Saint Charles, Missouri, United States
Washington University School of Medicine-Site Number:8400004
St Louis, Missouri, United States
Sierra Clinical Research-Site Number:8400035
Las Vegas, Nevada, United States
Va Western New York Healthcare-Site Number:8400067
Buffalo, New York, United States
IMA Clinical Research, LLC-Site Number:8400070
New York, New York, United States
The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019
Chapel Hill, North Carolina, United States
American Health Research-Site Number:8400061
Charlotte, North Carolina, United States
Duke Asthma, Allergy and Airway Center-Site Number:8400064
Durham, North Carolina, United States
Accellacare-Site Number:8400052
Wilmington, North Carolina, United States
Southeastern Research Center-Site Number:8400060
Winston-Salem, North Carolina, United States
Midwest Pulmonary and Sleep Research Center-Site Number:8400040
Dayton, Ohio, United States
Aventiv Research, Inc-Site Number:8400024
Dublin, Ohio, United States
OK Clinical Research-Site Number:8400005
Edmond, Oklahoma, United States
Velocity Clinical Research, Medford-Site Number:8400001
Medford, Oregon, United States
Jefferson Associates in Internal Medicine-Site Number:8400037
Clairton, Pennsylvania, United States
Temple University Hospital-Site Number:8400009
Philadelphia, Pennsylvania, United States
Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033
Pittsburgh, Pennsylvania, United States
Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063
Wyomissing, Pennsylvania, United States
VitaLink Research- Gaffney-Site Number:8400047
Gaffney, South Carolina, United States
VitaLink Research-Greenville-Site Number:8400007
Greenville, South Carolina, United States
Clinical Research of Charleston-Site Number:8400044
Mt. Pleasant, South Carolina, United States
Clinical Research of Rock Hill-Site Number:8400046
Rock Hill, South Carolina, United States
VitaLink Research - Spartanburg-Site Number:8400048
Spartanburg, South Carolina, United States
Clinical Trials Center of Middle Tennessee-Site Number:8400073
Franklin, Tennessee, United States
Bayer College of Medicine-Site Number:8400018
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center-Site Number:8400021
McKinney, Texas, United States
Sherman Clinical Research-Site Number:8400027
Sherman, Texas, United States
MultiCare Institute for Research and Innovation-Site Number:8400036
Tacoma, Washington, United States
Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008
Greenfield, Wisconsin, United States
Investigational Site Number :0320011
CABA, Buenos Aires, Argentina
Investigational Site Number :0320002
CABA, Buenos Aires, Argentina
Investigational Site Number :0320003
CABA, Buenos Aires, Argentina
Investigational Site Number :0320004
CABA, Buenos Aires, Argentina
Investigational Site Number :0320012
La Plata, Buenos Aires, Argentina
Investigational Site Number :0320007
Quilmes, Buenos Aires F.D., Argentina
Investigational Site Number :0320006
Rosario, Santa Fe Province, Argentina
Investigational Site Number :0320009
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number :0320001
Buenos Aires, , Argentina
Investigational Site Number :0320005
Buenos Aires, , Argentina
Investigational Site Number :0320008
Mar del Plata, , Argentina
Investigational Site Number :0320010
Mendoza, , Argentina
Investigational Site Number :1001004
Haskovo, , Bulgaria
Investigational Site Number :1001003
Montana, , Bulgaria
Investigational Site Number :1001006
Rousse, , Bulgaria
Investigational Site Number :1001009
Sofia, , Bulgaria
Investigational Site Number :1001002
Sofia, , Bulgaria
Investigational Site Number :1001001
Sofia, , Bulgaria
Investigational Site Number :1001005
Stara Zagora, , Bulgaria
Investigational Site Number :1001010
Troyan Municipality, , Bulgaria
Investigational Site Number :1240021
Edmonton, Alberta, Canada
Investigational Site Number :1240015
Edmonton, Alberta, Canada
Investigational Site Number :1240016
Sherwood Park, Alberta, Canada
Investigational Site Number :1240017
Vancouver, British Columbia, Canada
Investigational Site Number :1240007
Vancouver, British Columbia, Canada
Investigational Site Number :1240002
Burlington, Ontario, Canada
Investigational Site Number :1240012
Toronto, Ontario, Canada
Investigational Site Number :1240013
Windsor, Ontario, Canada
Investigational Site Number :1240009
Montreal, Quebec, Canada
Investigational Site Number :1240003
Montreal, Quebec, Canada
Investigational Site Number :1240001
Montreal, Quebec, Canada
Investigational Site Number :1240010
Sherbrooke, Quebec, Canada
Investigational Site Number :1240011
Sherbrooke, Quebec, Canada
Investigational Site Number :1240006
St-charles Borrommee, Quebec, Canada
Investigational Site Number :1240008
Trois-Rivières, Quebec, Canada
Investigational Site Number :1240020
Victoriaville, Quebec, Canada
Investigational Site Number :1240005
Québec, , Canada
Investigational Site Number :1240004
Québec, , Canada
Investigational Site Number :1240019
Québec, , Canada
Investigational Site Number :1240018
Québec, , Canada
Investigational Site Number :1520006
Curicó, Maule Region, Chile
Investigational Site Number :1520001
Talca, Maule Region, Chile
Investigational Site Number :1520009
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number :1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number :1520005
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number :1520008
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number :1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number :1520004
Quillota, Región de Valparaíso, Chile
Investigational Site Number :1560037
Baotou, , China
Investigational Site Number :1560006
Beijing, , China
Investigational Site Number :1560003
Changchun, , China
Investigational Site Number :1560022
Changsha, , China
Investigational Site Number :1560021
Changsha, , China
Investigational Site Number :1560001
Chengdu, , China
Investigational Site Number :1560017
Chengdu, , China
Investigational Site Number :1560012
Chongqing, , China
Investigational Site Number :1560005
Chongqing, , China
Investigational Site Number :1560053
Fuzhou, , China
Investigational Site Number :1560036
Guangzhou, , China
Investigational Site Number :1560019
Guangzhou, , China
Investigational Site Number :1560045
Haikou, , China
Investigational Site Number :1560018
Haikou, , China
Investigational Site Number :1560046
Hangzhou, , China
Investigational Site Number :1560009
Hefei, , China
Investigational Site Number :1560041
Hefei, , China
Investigational Site Number :1560015
Hohhot, , China
Investigational Site Number :1560008
Hohhot, , China
Investigational Site Number :1560027
Nanchang, , China
Investigational Site Number :1560034
Nanjing, , China
Investigational Site Number :1560032
Shanghai, , China
Investigational Site Number :1560013
Shanghai, , China
Investigational Site Number :1560007
Shanghai, , China
Investigational Site Number :1560014
Shenyang, , China
Investigational Site Number :1560004
Shenyang, , China
Investigational Site Number :1560051
Shenzhen, , China
Investigational Site Number :1560016
Shijiazhuang, , China
Investigational Site Number :1560024
Taiyuan, , China
Investigational Site Number :1560010
Tianjin, , China
Investigational Site Number :1560028
Ürümqi, , China
Investigational Site Number :1560052
Wuhan, , China
Investigational Site Number :1560020
Xi'an, , China
Investigational Site Number :1560054
Xuzhou, , China
Investigational Site Number :1560011
Yangzhou, , China
Investigational Site Number :1560031
Zhanjiang, , China
Investigational Site Number :1560002
Zhengzhou, , China
Investigational Site Number :2030002
Jindrichuv Hradec III, , Czechia
Investigational Site Number :2030005
Karlovy Vary, , Czechia
Investigational Site Number :2030009
Miroslav, , Czechia
Investigational Site Number :2030001
Nový Bor, , Czechia
Investigational Site Number :2030003
Prague, , Czechia
Investigational Site Number :2030008
Praha 6 - Brevnov, , Czechia
Investigational Site Number :2030004
Rokycany, , Czechia
Investigational Site Number :2030006
Strakonice, , Czechia
Investigational Site Number :2080003
Aalborg, , Denmark
Investigational Site Number :2080001
Copenhagen Nv, , Denmark
Investigational Site Number :2080002
Hvidovre, , Denmark
Investigational Site Number :2080006
Næstved, , Denmark
Investigational Site Number :2080005
Odense C, , Denmark
Investigational Site Number :2080004
Roskilde, , Denmark
Investigational Site Number :2080007
Vejle, , Denmark
Investigational Site Number :2460003
Pori, , Finland
Investigational Site Number :2460001
Turku, , Finland
Investigational Site Number :2760006
Berlin, , Germany
Investigational Site Number :2760009
Frankfurt am Main, , Germany
Investigational Site Number :2760002
Hamburg, , Germany
Investigational Site Number :2760007
Koblenz, , Germany
Investigational Site Number :2760011
Leipzig, , Germany
Investigational Site Number :2760010
Lübeck, , Germany
Investigational Site Number :2760008
Marburg, , Germany
Investigational Site Number :3480007
Balassagyarmat, , Hungary
Investigational Site Number :3480011
Budapest, , Hungary
Investigational Site Number :3480008
Edelény, , Hungary
Investigational Site Number :3480001
Gödöllö, , Hungary
Investigational Site Number :3480010
Hajdunánás, , Hungary
Investigational Site Number :3480002
Komárom, , Hungary
Investigational Site Number :3480003
Makó, , Hungary
Investigational Site Number :3480006
Mohács, , Hungary
Investigational Site Number :3480012
Püspökladány, , Hungary
Investigational Site Number :3480004
Százhalombatta, , Hungary
Investigational Site Number :3480005
Szombathely, , Hungary
Investigational Site Number :3760006
Ashkelon, , Israel
Investigational Site Number :3760007
Beersheba, , Israel
Investigational Site Number :3760003
Haifa, , Israel
Investigational Site Number :3760005
Jerusalem, , Israel
Investigational Site Number :3760004
Jerusalem, , Israel
Investigational Site Number :3760001
Petah Tikva, , Israel
Investigational Site Number :3760002
Rehovot, , Israel
Investigational Site Number :3800004
Cona, Ferrara, Italy
Investigational Site Number :3800003
Rozzano, Milano, Italy
Investigational Site Number :3800007
Pisa, , Italy
Investigational Site Number :3800001
Reggio Emilia, , Italy
Investigational Site Number :3800005
Roma, , Italy
Investigational Site Number :3920013
Kasuga-shi, Fukuoka, Japan
Investigational Site Number :3920011
Himeji-shi, Hyōgo, Japan
Investigational Site Number :3920023
Higashiibaraki-gun, Ibaraki, Japan
Investigational Site Number :3920014
Naka-gun, Ibaraki, Japan
Investigational Site Number :3920019
Takamatsu, Kagawa-ken, Japan
Investigational Site Number :3920027
Yokohama, Kanagawa, Japan
Investigational Site Number :3920003
Joyo-shi, Kyoto, Japan
Investigational Site Number :3920017
Kyoto, Kyoto, Japan
Investigational Site Number :3920006
Ueda-shi, Nagano, Japan
Investigational Site Number :3920029
Urasoe-shi, Okinawa, Japan
Investigational Site Number :3920018
Kawachinagano-shi, Osaka, Japan
Investigational Site Number :3920001
Kishiwada-shi, Osaka, Japan
Investigational Site Number :3920028
Osaka, Osaka, Japan
Investigational Site Number :3920012
Sakai-shi, Osaka, Japan
Investigational Site Number :3920021
Hamamatsu, Shizuoka, Japan
Investigational Site Number :3920008
Chuo-ku, Tokyo, Japan
Investigational Site Number :3920030
Chuo-ku, Tokyo, Japan
Investigational Site Number :3920005
Chuo-ku, Tokyo, Japan
Investigational Site Number :3920015
Kokubunji-shi, Tokyo, Japan
Investigational Site Number :3920016
Shinagawa-ku, Tokyo, Japan
Investigational Site Number :3920004
Toshima-ku, Tokyo, Japan
Investigational Site Number :3920026
Toshima-ku, Tokyo, Japan
Investigational Site Number :4840002
Guadalajara, Jalisco, Mexico
Investigational Site Number :4840001
Monterrey, Nuevo León, Mexico
Investigational Site Number :4840004
Chihuahua City, , Mexico
Investigational Site Number :4840003
Durango, , Mexico
Investigational Site Number :4840006
Mexico City, , Mexico
Investigational Site Number :4840007
Oaxaca City, , Mexico
Investigational Site Number :4840005
Veracruz, , Mexico
Investigational Site Number :6160016
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number :6160006
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number :6160009
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
Investigational Site Number :6160007
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number :6160015
Grodzisk Mazowiecki, Masovian Voivodeship, Poland
Investigational Site Number :6160012
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number :6160008
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number :6160014
Elblag, Pomeranian Voivodeship, Poland
Investigational Site Number :6160011
Katowice, Silesian Voivodeship, Poland
Investigational Site Number :6420001
Bucharest, , Romania
Investigational Site Number :6420009
Bucharest, , Romania
Investigational Site Number :6420008
Bucharest, , Romania
Investigational Site Number :6420003
Cluj-Napoca, , Romania
Investigational Site Number :6420004
Cluj-Napoca, , Romania
Investigational Site Number :6420007
Constanța, , Romania
Investigational Site Number :6420006
Timișoara, , Romania
Investigational Site Number :6420010
Timișoara, , Romania
Investigational Site Number :6430003
Chelyabinsk, , Russia
Investigational Site Number :6430004
Kazan', , Russia
Investigational Site Number :6430006
Moscow, , Russia
Investigational Site Number :6430001
Moscow, , Russia
Investigational Site Number :6430005
Moscow, , Russia
Investigational Site Number :6430008
Moscow, , Russia
Investigational Site Number :6430002
Moscow, , Russia
Investigational Site Number :6430009
Moscow, , Russia
Investigational Site Number :6430007
Saint Petersburg, , Russia
Investigational Site Number :7030007
Banská Bystrica, , Slovakia
Investigational Site Number :7030006
Humenné, , Slovakia
Investigational Site Number :7030003
Levice, , Slovakia
Investigational Site Number :7030001
Poprad, , Slovakia
Investigational Site Number :7030002
Spišská Nová Ves, , Slovakia
Investigational Site Number :4100003
Wŏnju, Gangwon-do, South Korea
Investigational Site Number :4100004
Seongnam-si, Gyeonggi-do, South Korea
Investigational Site Number :4100008
Incheon, Incheon-gwangyeoksi, South Korea
Investigational Site Number :4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number :4100009
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number :4100007
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number :7240096
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number :7240002
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240007
Sant Boi de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number :7240005
Mérida / Badajoz, Extremadura, Spain
Investigational Site Number :7240006
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number :7240003
Madrid, , Spain
Investigational Site Number :7240001
Málaga, , Spain
Investigational Site Number :7240010
Palma de Mallorca, , Spain
Investigational Site Number :7240004
Valencia, , Spain
Investigational Site Number :7520001
Lund, , Sweden
Investigational Site Number :7520002
Stockholm, , Sweden
Investigational Site Number :7920004
Ankara, , Turkey (Türkiye)
Investigational Site Number :7920001
Istanbul, , Turkey (Türkiye)
Investigational Site Number :7920006
Izmir, , Turkey (Türkiye)
Investigational Site Number :7920007
Izmir, , Turkey (Türkiye)
Investigational Site Number :7920008
Kırıkkale, , Turkey (Türkiye)
Investigational Site Number :7920005
Manisa, , Turkey (Türkiye)
Investigational Site Number :7920002
Mersin, , Turkey (Türkiye)
Investigational Site Number :8040003
Chernivtsi, , Ukraine
Investigational Site Number :8040001
Ivano-Frankivsk, , Ukraine
Investigational Site Number :8040006
Kharkiv, , Ukraine
Investigational Site Number :8040004
Kyiv, , Ukraine
Investigational Site Number :8040009
Odesa, , Ukraine
Investigational Site Number :8040002
Ternopil, , Ukraine
Investigational Site Number :8040005
Vinnytsia, , Ukraine
Investigational Site Number :8040007
Zhytomyr, , Ukraine
Countries
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References
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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.
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.
Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB. Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS. Chest. 2025 Jul;168(1):56-66. doi: 10.1016/j.chest.2025.01.029. Epub 2025 Jan 31.
Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, 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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001953-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1211-8804
Identifier Type: OTHER
Identifier Source: secondary_id
EFC15804
Identifier Type: -
Identifier Source: org_study_id
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