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Pivotal undersøgelse for at vurdere effektiviteten, sikkerheden og tolerabiliteten af Dupilumab hos patienter med moderat til svær KOL med type 2-betændelse (BOREAS)

30. januar 2024 opdateret af: Sanofi

Et randomiseret, dobbeltblindt, placebokontrolleret, parallelgruppe, 52-ugers pivotalt studie for at vurdere effektiviteten, sikkerheden og tolerabiliteten af Dupilumab hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL) med type 2-betændelse

Primært mål:

For at evaluere effektiviteten af dupilumab administreret hver 2. uge hos patienter med moderat eller svær kronisk obstruktiv lungesygdom (KOL) målt ved

Årlig rate af akut moderat og svær KOL-eksacerbation (AECOPD)

Sekundære mål:

For at evaluere effekten af dupilumab administreret hver anden uge

Præbronkodilatator tvunget ekspiratorisk volumen på 1 sekund (FEV1) over 12 uger sammenlignet med placebo
Sundhedsrelateret livskvalitet, vurderet ved ændringen fra baseline til uge 52 i St. George's Respiratory Questionnaire (SGRQ)
Præbronkodilatator FEV1 over 52 uger sammenlignet med placebo
Lungefunktionsvurderinger
Moderate og svære KOL-eksacerbationer
At evaluere sikkerhed og tolerabilitet
For at evaluere dupilumab systemisk eksponering og forekomst af anti-lægemiddelantistoffer (ADA)

Studieoversigt

Status

Afsluttet

Betingelser

Kronisk obstruktiv lungesygdom

Intervention / Behandling

Detaljeret beskrivelse

Cirka 68 uger inklusive en 4-ugers screeningsperiode, en 52-ugers behandlingsperiode og 12 ugers opfølgning.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

939

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Argentina
- - Buenos Aires, Argentina, C1121ABE
    - Investigational Site Number :0320001
  - Buenos Aires, Argentina
    - Investigational Site Number :0320005
  - Mar Del Plata, Argentina, B7600
    - Investigational Site Number :0320008
  - Mendoza, Argentina, 5500
    - Investigational Site Number :0320010
- Buenos Aires
  - Caba, Buenos Aires, Argentina, 1430
    - Investigational Site Number :0320011
  - Caba, Buenos Aires, Argentina, C1414AIF
    - Investigational Site Number :0320002
  - Caba, Buenos Aires, Argentina, C1425BEN
    - Investigational Site Number :0320003
  - Caba, Buenos Aires, Argentina, C1425FVH
    - Investigational Site Number :0320004
  - La Plata, Buenos Aires, Argentina, B1900BNN
    - Investigational Site Number :0320012
- Ciudad De Buenos Aires
  - Quilmes, Ciudad De Buenos Aires, Argentina, B1878FNR
    - Investigational Site Number :0320007
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DBS
    - Investigational Site Number :0320006
- Tucumán
  - San Miguel de Tucumán, Tucumán, Argentina, T4000IAR
    - Investigational Site Number :0320009
Bulgarien
- - Haskovo, Bulgarien, 6305
    - Investigational Site Number :1001004
  - Montana, Bulgarien, 3400
    - Investigational Site Number :1001003
  - Ruse, Bulgarien, 7002
    - Investigational Site Number :1001006
  - Sofia, Bulgarien, 1202
    - Investigational Site Number :1001009
  - Sofia, Bulgarien, 1233
    - Investigational Site Number :1001002
  - Sofia, Bulgarien, 1680
    - Investigational Site Number :1001001
  - Stara Zagora, Bulgarien, 6001
    - Investigational Site Number :1001005
  - Troyan, Bulgarien, 5600
    - Investigational Site Number :1001010
Canada
- - Quebec, Canada, G1V 4W2
    - Investigational Site Number :1240004
  - Quebec, Canada, G1V 4G5
    - Investigational Site Number :1240005
  - Quebec, Canada, G3K 2P8
    - Investigational Site Number :1240019
  - Quebec, Canada, GIS 2L6
    - Investigational Site Number :1240018
- Alberta
  - Edmonton, Alberta, Canada, T5H4B9
    - Investigational Site Number :1240021
  - Edmonton, Alberta, Canada, T6G 2G3
    - Investigational Site Number :1240015
  - Sherwood Park, Alberta, Canada, T8H 0N2
    - Investigational Site Number :1240016
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Investigational Site Number :1240017
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Investigational Site Number :1240007
- Ontario
  - Burlington, Ontario, Canada, L7N 3V2
    - Investigational Site Number :1240002
  - Toronto, Ontario, Canada, M5T 3A9
    - Investigational Site Number :1240012
  - Windsor, Ontario, Canada, N8X 5A6
    - Investigational Site Number :1240013
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Investigational Site Number :1240001
  - Montreal, Quebec, Canada, H1M 1B1
    - Investigational Site Number :1240009
  - Montreal, Quebec, Canada, H1T 1C8
    - Investigational Site Number :1240003
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Investigational Site Number :1240010
  - Sherbrooke, Quebec, Canada, J1L 0H8
    - Investigational Site Number :1240011
  - St-charles Borrommee, Quebec, Canada, J6E 2B4
    - Investigational Site Number :1240006
  - Trois-Rivieres, Quebec, Canada, G8T 7A1
    - Investigational Site Number :1240008
  - Victoriaville, Quebec, Canada, G6P 6P6
    - Investigational Site Number :1240020
Chile
- Maule
  - Curicó, Maule, Chile, 3341643
    - Investigational Site Number :1520006
  - Talca, Maule, Chile
    - Investigational Site Number :1520001
- Reg Metropolitana De Santiago
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500587
    - Investigational Site Number :1520009
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500692
    - Investigational Site Number :1520003
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500698
    - Investigational Site Number :1520005
  - Santiago, Reg Metropolitana De Santiago, Chile, 8380453
    - Investigational Site Number :1520008
  - Santiago, Reg Metropolitana De Santiago, Chile, 8910131
    - Investigational Site Number :1520002
- Valparaíso
  - Quillota, Valparaíso, Chile, 2260877
    - Investigational Site Number :1520004
Danmark
- - Copenhagen Nv, Danmark, 2400
    - Investigational Site Number :2080001
  - Hvidovre, Danmark, 2650
    - Investigational Site Number :2080002
  - Naestved, Danmark, 4700
    - Investigational Site Number :2080006
  - Odense C, Danmark, 5000
    - Investigational Site Number :2080005
  - Roskilde, Danmark, 4000
    - Investigational Site Number :2080004
  - Vejle, Danmark, 7100
    - Investigational Site Number :2080007
  - Ålborg, Danmark, 9100
    - Investigational Site Number :2080003
Den Russiske Føderation
- - Chelyabinsk, Den Russiske Føderation, 454091
    - Investigational Site Number :6430003
  - Kazan, Den Russiske Føderation, 420008
    - Investigational Site Number :6430004
  - Moscow, Den Russiske Føderation, 105077
    - Investigational Site Number :6430006
  - Moscow, Den Russiske Føderation, 115093
    - Investigational Site Number :6430001
  - Moscow, Den Russiske Føderation, 115280
    - Investigational Site Number :6430005
  - Moscow, Den Russiske Føderation, 115682
    - Investigational Site Number :6430008
  - Moscow, Den Russiske Føderation, 117546
    - Investigational Site Number :6430002
  - Moscow, Den Russiske Føderation, 125284
    - Investigational Site Number :6430009
  - St-Petersburg, Den Russiske Føderation, 193231
    - Investigational Site Number :6430007
Finland
- - Pori, Finland, 28500
    - Investigational Site Number :2460003
  - Turku, Finland, 20520
    - Investigational Site Number :2460001
Forenede Stater
- Alabama
  - Andalusia, Alabama, Forenede Stater, 36420
    - SEC Clinical Research, LLC-Site Number:8400030
  - Birmingham, Alabama, Forenede Stater, 35209-6802
    - Clinical Research Center of Alabama, LLC-Site Number:8400041
  - Birmingham, Alabama, Forenede Stater, 35294
    - UAB Lung Health Center-Site Number:8400013
  - Dothan, Alabama, Forenede Stater, 36303
    - SEC Clinical Research, LLC-Site Number:8400059
  - Mobile, Alabama, Forenede Stater, 36608
    - Pulmonary Associates of Mobile, P.C.-Site Number:8400057
- Colorado
  - Colorado Springs, Colorado, Forenede Stater, 80907
    - Asthma and Allergy Associates, PC-Site Number:8400034
- Florida
  - Clearwater, Florida, Forenede Stater, 33765
    - Clinical Research Of West Florida Inc-Site Number:8400010
  - Greenacres City, Florida, Forenede Stater, 33467
    - Finlay Medical Research-Site Number:8400014
  - Miami, Florida, Forenede Stater, 33125
    - Project 4 research, Inc.-Site Number:8400023
  - Miami, Florida, Forenede Stater, 33126
    - Finlay Medical Research-Site Number:8400062
  - Ocala, Florida, Forenede Stater, 34470
    - Renstar Medical Research-Site Number:8400051
  - Orlando, Florida, Forenede Stater, 32825
    - Florida Institute for Clinical Research, LLC-Site Number:8400029
  - Panama City, Florida, Forenede Stater, 32405
    - Emerald Coast Research Associates-Site Number:8400032
  - Sarasota, Florida, Forenede Stater, 34239
    - Sarasota Clinical Research-Site Number:8400026
- Georgia
  - Dacula, Georgia, Forenede Stater, 30019
    - VitaLink research-Hamilton Mill-Site Number:8400055
  - Marietta, Georgia, Forenede Stater, 30060
    - DC Research Works-Site Number:8400016
  - Woodstock, Georgia, Forenede Stater, 30189
    - North Georgia Clinical Research-Site Number:8400025
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21224
    - Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012
  - White Marsh, Maryland, Forenede Stater, 21162
    - Asthma Allergy & Sinus Center-Site Number:8400038
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109
    - Michigan Medicine (University of Michigan)-Site Number:8400050
- Minnesota
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Lanmark Center 2-46-Site Number:8400065
- Missouri
  - Saint Charles, Missouri, Forenede Stater, 63301
    - Midwest Chest Consultants, P.C.-Site Number:8400011
  - Saint Louis, Missouri, Forenede Stater, 63104
    - Washington University School of Medicine-Site Number:8400004
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89106
    - Sierra Clinical Research-Site Number:8400035
- New York
  - Buffalo, New York, Forenede Stater, 14215
    - Va Western New York Healthcare-Site Number:8400067
  - New York, New York, Forenede Stater, 10036
    - IMA Clinical Research, LLC-Site Number:8400070
- North Carolina
  - Chapel Hill, North Carolina, Forenede Stater, 27514
    - The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019
  - Charlotte, North Carolina, Forenede Stater, 28277
    - American Health Research-Site Number:8400061
  - Durham, North Carolina, Forenede Stater, 27705
    - Duke Asthma, Allergy and Airway Center-Site Number:8400064
  - Wilmington, North Carolina, Forenede Stater, 28401
    - Accellacare-Site Number:8400052
  - Winston-Salem, North Carolina, Forenede Stater, 27103-4027
    - Southeastern Research Center-Site Number:8400060
- Ohio
  - Dayton, Ohio, Forenede Stater, 45459
    - Midwest Pulmonary and Sleep Research Center-Site Number:8400040
  - Dublin, Ohio, Forenede Stater, 43016
    - Aventiv Research, Inc-Site Number:8400024
- Oklahoma
  - Edmond, Oklahoma, Forenede Stater, 73034
    - OK Clinical Research-Site Number:8400005
- Oregon
  - Medford, Oregon, Forenede Stater, 97504
    - Velocity Clinical Research, Medford-Site Number:8400001
- Pennsylvania
  - Clairton, Pennsylvania, Forenede Stater, 15025
    - Jefferson Associates in Internal Medicine-Site Number:8400037
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - Temple University Hospital-Site Number:8400009
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033
  - Wyomissing, Pennsylvania, Forenede Stater, 19610
    - Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063
- South Carolina
  - Easley, South Carolina, Forenede Stater, 29640
    - VitaLink Research-Easley-Site Number:8400022
  - Gaffney, South Carolina, Forenede Stater, 29340
    - VitaLink Research- Gaffney-Site Number:8400047
  - Greenville, South Carolina, Forenede Stater, 29615
    - VitaLink Research-Greenville-Site Number:8400007
  - Mount Pleasant, South Carolina, Forenede Stater, 29464
    - Clinical Research of Charleston-Site Number:8400044
  - Rock Hill, South Carolina, Forenede Stater, 29732
    - Clinical Research of Rock Hill-Site Number:8400046
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - VitaLink Research - Spartanburg-Site Number:8400048
- Tennessee
  - Franklin, Tennessee, Forenede Stater, 37067
    - Clinical Trials Center of Middle Tennessee-Site Number:8400073
- Texas
  - Houston, Texas, Forenede Stater, 77030
    - Bayer College of Medicine-Site Number:8400018
  - McKinney, Texas, Forenede Stater, 75069
    - Metroplex Pulmonary and Sleep Center-Site Number:8400021
  - Sherman, Texas, Forenede Stater, 75092
    - Sherman Clinical Research-Site Number:8400027
- Washington
  - Tacoma, Washington, Forenede Stater, 98405
    - MultiCare Institute for Research and Innovation-Site Number:8400036
- Wisconsin
  - Greenfield, Wisconsin, Forenede Stater, 53228
    - Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008
Israel
- - Ashkelon, Israel, 78278
    - Investigational Site Number :3760006
  - Beer Sheva, Israel, 84101
    - Investigational Site Number :3760007
  - Haifa, Israel, 34362
    - Investigational Site Number :3760003
  - Jerusalem, Israel, 91031
    - Investigational Site Number :3760005
  - Jerusalem, Israel, 91120
    - Investigational Site Number :3760004
  - Petah-Tikva, Israel, 49100
    - Investigational Site Number :3760001
  - Rehovot, Israel, 76100
    - Investigational Site Number :3760002
Italien
- - Pisa, Italien, 56124
    - Investigational Site Number :3800007
  - Reggio Emilia, Italien, 42123
    - Investigational Site Number :3800001
  - Roma, Italien, 00133
    - Investigational Site Number :3800005
- Ferrara
  - Cona, Ferrara, Italien, 44124
    - Investigational Site Number :3800004
- Milano
  - Rozzano, Milano, Italien, 20089
    - Investigational Site Number :3800003
Japan
- Fukuoka
  - Kasuga-shi, Fukuoka, Japan, 816-0813
    - Investigational Site Number :3920013
- Hyogo
  - Himeji-shi, Hyogo, Japan, 670-0849
    - Investigational Site Number :3920011
- Ibaraki
  - Higashiibaraki-gun, Ibaraki, Japan, 311-3193
    - Investigational Site Number :3920023
  - Naka-gun, Ibaraki, Japan, 319-1113
    - Investigational Site Number :3920014
- Kagawa
  - Takamatsu-shi, Kagawa, Japan, 761-8073
    - Investigational Site Number :3920019
- Kanagawa
  - Yokohama-shi, Kanagawa, Japan, 223-0059
    - Investigational Site Number :3920027
- Kyoto
  - Joyo-shi, Kyoto, Japan, 610-0113
    - Investigational Site Number :3920003
  - Kyoto-shi, Kyoto, Japan, 612-8555
    - Investigational Site Number :3920017
- Nagano
  - Ueda-shi, Nagano, Japan
    - Investigational Site Number :3920006
- Okinawa
  - Urasoe-shi, Okinawa, Japan, 901-2121
    - Investigational Site Number :3920029
- Osaka
  - Kawachinagano-shi, Osaka, Japan, 586-8521
    - Investigational Site Number :3920018
  - Kishiwada-shi, Osaka, Japan, 596-8501
    - Investigational Site Number :3920001
  - Osaka-shi, Osaka, Japan, 531-0073
    - Investigational Site Number :3920028
  - Sakai-shi, Osaka, Japan, 591-8555
    - Investigational Site Number :3920012
- Shizuoka
  - Hamamatsu-shi, Shizuoka, Japan, 434-8511
    - Investigational Site Number :3920021
- Tokyo
  - Chuo-ku, Tokyo, Japan, 103-0022
    - Investigational Site Number :3920008
  - Chuo-ku, Tokyo, Japan, 103-0028
    - Investigational Site Number :3920030
  - Chuo-ku, Tokyo, Japan, 104-0031
    - Investigational Site Number :3920005
  - Kokubunji-shi, Tokyo, Japan, 185-0014
    - Investigational Site Number :3920015
  - Shinagawa-ku, Tokyo, Japan, 140-8522
    - Investigational Site Number :3920016
  - Toshima-ku, Tokyo, Japan, 170-0003
    - Investigational Site Number :3920004
  - Toshima-ku, Tokyo, Japan, 1710014
    - Investigational Site Number :3920026
Kalkun
- - Ankara, Kalkun, 06100
    - Investigational Site Number :7920004
  - Istanbul, Kalkun, 34098
    - Investigational Site Number :7920001
  - Izmir, Kalkun, 35040
    - Investigational Site Number :7920006
  - Izmir, Kalkun, 35110
    - Investigational Site Number :7920007
  - Kirikkale, Kalkun, 71450
    - Investigational Site Number :7920008
  - Manisa, Kalkun, 45000
    - Investigational Site Number :7920005
  - Mersin, Kalkun, 33070
    - Investigational Site Number :7920002
Kina
- - Baotou, Kina, 014010
    - Investigational Site Number :1560037
  - Beijing, Kina
    - Investigational Site Number :1560006
  - Changchun, Kina, 130021
    - Investigational Site Number :1560003
  - Changsha, Kina, 410011
    - Investigational Site Number :1560022
  - Changsha, Kina, 410013
    - Investigational Site Number :1560021
  - Chengdu, Kina, 610041
    - Investigational Site Number :1560001
  - Chengdu, Kina, 611130
    - Investigational Site Number :1560017
  - Chongqing, Kina, 400037
    - Investigational Site Number :1560012
  - Chongqing, Kina, 400038
    - Investigational Site Number :1560005
  - Fuzhou, Kina, 350001
    - Investigational Site Number :1560053
  - Guangzhou, Kina, 510150
    - Investigational Site Number :1560036
  - Guangzhou, Kina, 510163
    - Investigational Site Number :1560019
  - Haikou, Kina, 570216
    - Investigational Site Number :1560045
  - Haikou, Kina, 570311
    - Investigational Site Number :1560018
  - Hangzhou, Kina, 310009
    - Investigational Site Number :1560046
  - Hefei, Kina, 230022
    - Investigational Site Number :1560009
  - Hefei, Kina
    - Investigational Site Number :1560041
  - Hohhot, Kina, 010017
    - Investigational Site Number :1560015
  - Hohhot, Kina, 010050
    - Investigational Site Number :1560008
  - Nanchang, Kina, 330006
    - Investigational Site Number :1560027
  - Nanjing, Kina, 210009
    - Investigational Site Number :1560034
  - Shanghai, Kina, 200025
    - Investigational Site Number :1560032
  - Shanghai, Kina, 200080
    - Investigational Site Number :1560013
  - Shanghai, Kina, 200433
    - Investigational Site Number :1560007
  - Shenyang, Kina, 110001
    - Investigational Site Number :1560014
  - Shenyang, Kina, 110004
    - Investigational Site Number :1560004
  - Shenzhen, Kina, 518020
    - Investigational Site Number :1560051
  - Shijiazhuang, Kina, 050000
    - Investigational Site Number :1560016
  - Taiyuan, Kina, 030001
    - Investigational Site Number :1560024
  - Tianjin, Kina, 300052
    - Investigational Site Number :1560010
  - Urumchi, Kina, 830054
    - Investigational Site Number :1560028
  - Wuhan, Kina, 430014
    - Investigational Site Number :1560052
  - Xi'An, Kina, 710061
    - Investigational Site Number :1560020
  - Xuzhou, Kina, 221002
    - Investigational Site Number :1560054
  - Yangzhou, Kina, 225001
    - Investigational Site Number :1560011
  - Zhanjiang, Kina, 524001
    - Investigational Site Number :1560031
  - Zhengzhou, Kina, 450003
    - Investigational Site Number :1560002
Korea, Republikken
- Gangwon-do
  - Wonju, Gangwon-do, Korea, Republikken, 26426
    - Investigational Site Number :4100003
- Gyeonggi-do
  - Seongnam, Gyeonggi-do, Korea, Republikken, 13620
    - Investigational Site Number :4100004
- Incheon-gwangyeoksi
  - Incheon, Incheon-gwangyeoksi, Korea, Republikken, 21431
    - Investigational Site Number :4100008
- Seoul-teukbyeolsi
  - Seoul, Seoul-teukbyeolsi, Korea, Republikken, 03080
    - Investigational Site Number :4100001
  - Seoul, Seoul-teukbyeolsi, Korea, Republikken, 03312
    - Investigational Site Number :4100009
  - Seoul, Seoul-teukbyeolsi, Korea, Republikken, 05505
    - Investigational Site Number :4100007
Mexico
- - Chihuahua, Mexico, 31000
    - Investigational Site Number :4840004
  - Durango, Mexico, 34080
    - Investigational Site Number :4840003
  - Mexico Distrito Federal, Mexico, 06700
    - Investigational Site Number :4840006
  - Oaxaca, Mexico, 68000
    - Investigational Site Number :4840007
  - Veracruz, Mexico, 91910
    - Investigational Site Number :4840005
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - Investigational Site Number :4840002
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Investigational Site Number :4840001
Polen
- Kujawsko-pomorskie
  - Grudziadz, Kujawsko-pomorskie, Polen, 86-300
    - Investigational Site Number :6160009
- Malopolskie
  - Krakow, Malopolskie, Polen, 31-559
    - Investigational Site Number :6160007
- Mazowieckie
  - Grodzisk Mazowiecki, Mazowieckie, Polen, 05-825
    - Investigational Site Number :6160015
  - Warszawa, Mazowieckie, Polen, 01-456
    - Investigational Site Number :6160012
- Podlaskie
  - Bialystok, Podlaskie, Polen, 15-044
    - Investigational Site Number :6160008
- Pomorskie
  - Elblag, Pomorskie, Polen, 82-300
    - Investigational Site Number :6160014
- Slaskie
  - Katowice, Slaskie, Polen, 40-648
    - Investigational Site Number :6160011
- Wielkopolskie
  - Poznan, Wielkopolskie, Polen, 60-214
    - Investigational Site Number :6160016
  - Poznan, Wielkopolskie, Polen, 61-578
    - Investigational Site Number :6160006
Rumænien
- - Bucharest, Rumænien, 011461
    - Investigational Site Number :6420001
  - Bucuresti, Rumænien, 030303
    - Investigational Site Number :6420009
  - Bucuresti, Rumænien, 050159
    - Investigational Site Number :6420008
  - Cluj-Napoca, Rumænien, 400371
    - Investigational Site Number :6420003
  - Cluj-Napoca, Rumænien, 400371
    - Investigational Site Number :6420004
  - Constanta, Rumænien, 900002
    - Investigational Site Number :6420007
  - Timisoara, Rumænien, 300310
    - Investigational Site Number :6420006
  - Timisoara, Rumænien, 300310
    - Investigational Site Number :6420010
Slovakiet
- - Banska Bystrica, Slovakiet, 97517
    - Investigational Site Number :7030007
  - Humenne, Slovakiet, 066 01
    - Investigational Site Number :7030006
  - Levice, Slovakiet, 93401
    - Investigational Site Number :7030003
  - Poprad, Slovakiet, 058 01
    - Investigational Site Number :7030001
  - Spisska Nova Ves, Slovakiet, 05201
    - Investigational Site Number :7030002
Spanien
- - Madrid, Spanien, 28007
    - Investigational Site Number :7240003
  - Málaga, Spanien, 29010
    - Investigational Site Number :7240001
  - Palma de Mallorca, Spanien, 07120
    - Investigational Site Number :7240010
  - Valencia, Spanien, 46015
    - Investigational Site Number :7240004
- A Coruña [La Coruña]
  - Santiago de Compostela, A Coruña [La Coruña], Spanien, 15706
    - Investigational Site Number :7240096
- Barcelona [Barcelona]
  - Barcelona, Barcelona [Barcelona], Spanien, 08035
    - Investigational Site Number :7240002
  - Sant Boi de Llobregat, Barcelona [Barcelona], Spanien, 08830
    - Investigational Site Number :7240007
- Extremadura
  - Mérida / Badajoz, Extremadura, Spanien, 06800
    - Investigational Site Number :7240005
- Madrid
  - Pozuelo de Alarcón, Madrid, Spanien, 28223
    - Investigational Site Number :7240006
Sverige
- - Lund, Sverige, 221 85
    - Investigational Site Number :7520001
  - Stockholm, Sverige, 114 46
    - Investigational Site Number :7520002
Tjekkiet
- - Jindrichuv Hradec III, Tjekkiet, 37701
    - Investigational Site Number :2030002
  - Karlovy Vary, Tjekkiet, 36017
    - Investigational Site Number :2030005
  - Miroslav, Tjekkiet, 67172
    - Investigational Site Number :2030009
  - Novy Bor, Tjekkiet, 47301
    - Investigational Site Number :2030001
  - Praha 4, Tjekkiet, 14059
    - Investigational Site Number :2030003
  - Praha 6 - Brevnov, Tjekkiet, 16900
    - Investigational Site Number :2030008
  - Rokycany, Tjekkiet, 33722
    - Investigational Site Number :2030004
  - Strakonice, Tjekkiet, 38601
    - Investigational Site Number :2030006
Tyskland
- - Berlin, Tyskland, 10787
    - Investigational Site Number :2760006
  - Frankfurt am Main, Tyskland, 60596
    - Investigational Site Number :2760009
  - Hamburg, Tyskland, 20354
    - Investigational Site Number :2760002
  - Koblenz, Tyskland, 56068
    - Investigational Site Number :2760007
  - Leipzig, Tyskland, 04347
    - Investigational Site Number :2760011
  - Lübeck, Tyskland, 23552
    - Investigational Site Number :2760010
  - Marburg, Tyskland, 35043
    - Investigational Site Number :2760008
Ukraine
- - Chernivtsi, Ukraine, 58001
    - Investigational Site Number :8040003
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number :8040001
  - Kharkiv, Ukraine, 61166
    - Investigational Site Number :8040006
  - Kyiv, Ukraine, 02125
    - Investigational Site Number :8040004
  - Odesa, Ukraine, 65025
    - Investigational Site Number :8040009
  - Ternopil, Ukraine, 46000
    - Investigational Site Number :8040002
  - Vinnytsya, Ukraine, 21001
    - Investigational Site Number :8040005
  - Zhytomyr, Ukraine, 10002
    - Investigational Site Number :8040007
Ungarn
- - Balassagyarmat, Ungarn, 2660
    - Investigational Site Number :3480007
  - Budapest, Ungarn, 1122
    - Investigational Site Number :3480011
  - Edelény, Ungarn, 3780
    - Investigational Site Number :3480008
  - Gödöllö, Ungarn, 2100
    - Investigational Site Number :3480001
  - Hajdunánás, Ungarn, 4080
    - Investigational Site Number :3480010
  - Komarom, Ungarn, 2900
    - Investigational Site Number :3480002
  - Makó, Ungarn, 6900
    - Investigational Site Number :3480003
  - Mohács, Ungarn, 7700
    - Investigational Site Number :3480006
  - Puspokladany, Ungarn, 4150
    - Investigational Site Number :3480012
  - Szombathely, Ungarn, 9700
    - Investigational Site Number :3480005
  - Százhalombatta, Ungarn, 2440
    - Investigational Site Number :3480004

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Deltagere med en lægediagnose af KOL, som opfylder følgende kriterier ved screening:
- Nuværende eller tidligere rygere med en rygehistorie på ≥10 pakkeår.
- Moderat til svær KOL (post-bronkodilatator FEV1/ forceret vitalkapacitet [FVC] ratio 30% og ≤70%).
- Medical Research Council (MRC) Dyspnø-skala grad ≥2.
- Patientrapporteret historie med tegn og symptomer på kronisk bronkitis (kronisk produktiv hoste) i 3 måneder om året indtil screening i fravær af andre kendte årsager til kronisk hoste.
- Dokumenteret anamnese med høj eksacerbationsrisiko defineret som eksacerbationshistorie på ≥2 moderat eller ≥1 svær inden for året før inklusion. Mindst én eksacerbation skulle være opstået, mens patienten tog inhaleret kortikosteroid (ICS)/langtidsvirkende beta-agonist (LABA)/langtidsvirkende muskarinantagonist (LAMA) (eller LABA/LAMA, hvis ICS er kontraindiceret). Moderate eksacerbationer registreres af investigator og defineres som akut eksacerbation af KOL (AECOPD), der kræver enten systemiske kortikosteroider (intramuskulært, intravenøst eller oralt) og/eller antibiotika. En af de to nødvendige moderate eksacerbationer skal kræve brug af systemiske kortikosteroider. Alvorlige eksacerbationer registreres af investigator og defineres som AECOPD, der kræver hospitalsindlæggelse eller observation >24 timer i akutmodtagelse/akutklinik.
- Tredobbelt baggrundsterapi (ICS + LABA + LAMA) i 3 måneder før randomisering med en stabil dosis af medicin i ≥1 måned før besøg 1; Dobbeltbehandling (LABA + LAMA) tilladt, hvis ICS er kontraindiceret.
Bevis for type 2-betændelse: Patienter med eosinofiler i blodet ≥300 celler/mikroliter ved besøg 1.

Ekskluderingskriterier:

KOL-diagnose i mindre end 12 måneder før randomisering.
En aktuel astmadiagnose eller astmahistorie i henhold til 2018 Global Initiative for Asthma (GINA) retningslinjer eller andre accepterede retningslinjer.
Betydende lungesygdom bortset fra KOL (f.eks. lungefibrose, sarkoidose, interstitiel lungesygdom, pulmonal hypertension, bronkiektasi, Churg-Strauss syndrom osv.) eller en anden diagnosticeret lunge- eller systemisk sygdom forbundet med forhøjede perifere eosinofiltal.
Cor pulmonale, tegn på højre hjertesvigt.
Behandling med ilt på mere end 12 timer pr.
Hyperkapni, der kræver to-niveau ventilation.
AECOPD som defineret i inklusionskriterier inden for 4 uger før screening eller under screeningsperioden.
Luftvejsinfektion inden for 4 uger før screening eller under screeningsperioden.
Anamnese med eller planlagt pneumonektomi eller lungevolumenreduktionskirurgi. Patienter, der deltager i den akutte fase af et lungerehabiliteringsprogram, dvs. som startede rehabilitering
Diagnose af α-1 anti-trypsin mangel.

Ovenstående information er ikke beregnet til at indeholde alle overvejelser, der er relevante for en patients potentielle deltagelse i et klinisk forsøg.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Dupilumab Deltagerne modtog dupilumab 300 mg indgivet som subkutane injektioner q2w op til maksimalt 52 uger (sidste dosis administreret i uge 50, EOT-besøg fandt sted 2 uger efter sidste administration af behandling, dvs. i uge 52).	Medicin: Dupilumab SAR231893 Lægemiddelform: Injektionsvæske, opløsning Administrationsvej: Subkutan Andre navne: Dupixent Medicin: Inhaleret kortikosteroid Lægemiddelform: Inhalationspulver Indgivelsesvej: Oral inhalation Medicin: Inhaleret langtidsvirkende beta-agonist Lægemiddelform: Inhalationspulver Indgivelsesvej: Oral inhalation Medicin: Inhaleret langtidsvirkende muskarin antagonist Lægemiddelform: Inhalationspulver Indgivelsesvej: Oral inhalation
Placebo komparator: Placebo Deltagerne modtog placebo matchet med dupilumab 300 mg som subkutane (SC) injektioner q2w op til maksimalt 52 uger (sidste dosis administreret ved uge 50, behandlingsslutbesøg [EOT] fandt sted 2 uger efter sidste administration af behandling, dvs. ved uge 52 ).	Medicin: Inhaleret kortikosteroid Lægemiddelform: Inhalationspulver Indgivelsesvej: Oral inhalation Medicin: Inhaleret langtidsvirkende beta-agonist Lægemiddelform: Inhalationspulver Indgivelsesvej: Oral inhalation Medicin: Inhaleret langtidsvirkende muskarin antagonist Lægemiddelform: Inhalationspulver Indgivelsesvej: Oral inhalation Medicin: Placebo Lægemiddelform: Injektionsvæske, opløsning Administrationsvej: Subkutan

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Dupilumab

Deltagerne modtog dupilumab 300 mg indgivet som subkutane injektioner q2w op til maksimalt 52 uger (sidste dosis administreret i uge 50, EOT-besøg fandt sted 2 uger efter sidste administration af behandling, dvs. i uge 52).

Medicin: Dupilumab SAR231893

Lægemiddelform: Injektionsvæske, opløsning

Administrationsvej: Subkutan

Andre navne:

Dupixent

Medicin: Inhaleret kortikosteroid