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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 (NOTUS)

21. marts 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 anden uge hos patienter med moderat eller svær kronisk obstruktiv lungesygdom (KOL) målt ved

Årlig frekvens af akut moderat eller 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 antistof antistoffer (ADA)

Studieoversigt

Status

Aktiv, ikke rekrutterende

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)

935

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 : 0320002
  - Launs Este, Argentina, B1824KAJ
    - Investigational Site Number : 0320012
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, CP 1884
    - Investigational Site Number : 0320007
  - Caba, Buenos Aires, Argentina, C1425BEN
    - Investigational Site Number : 0320001
  - Caba, Buenos Aires, Argentina, C1122AAK
    - Investigational Site Number : 0320006
  - Caba, Buenos Aires, Argentina, C1425FVH
    - Investigational Site Number : 0320003
  - Caba, Buenos Aires, Argentina, C1414AIF
    - Investigational Site Number : 0320004
  - La Plata, Buenos Aires, Argentina, B1900BNN
    - Investigational Site Number : 0320010
  - Lobos, Buenos Aires, Argentina, 7240
    - Investigational Site Number : 0320013
- Ciudad De Buenos Aires
  - Quilmes, Ciudad De Buenos Aires, Argentina, B1878FNR
    - Investigational Site Number : 0320005
- Córdoba
  - Cordoba, Córdoba, Argentina, X5003DCE
    - Investigational Site Number : 0320011
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DEJ
    - Investigational Site Number : 0320008
  - Rosario, Santa Fe, Argentina, S2002OJP
    - Investigational Site Number : 0320009
Australien
- South Australia
  - Kent Town, South Australia, Australien, 5067
    - Investigational Site Number : 0360008
- Victoria
  - Clayton, Victoria, Australien, 3168
    - Investigational Site Number : 0360005
- Western Australia
  - Spearwood, Western Australia, Australien, 6163
    - Investigational Site Number : 0360001
Belgien
- - Edegem, Belgien, 2650
    - Investigational Site Number : 0560002
  - Leuven, Belgien, 3000
    - Investigational Site Number : 0560001
  - Liege, Belgien, 4000
    - Investigational Site Number : 0560003
  - Mechelen, Belgien, 2800
    - Investigational Site Number : 0560004
Brasilien
- Bahia
  - Salvador, Bahia, Brasilien, 40150-150
    - SER da Bahia Site Number : 0760019
- Espírito Santo
  - Vitoria, Espírito Santo, Brasilien, 29055 450
    - CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760020
- Rio Grande Do Sul
  - Passo Fundo, Rio Grande Do Sul, Brasilien, 99010-120
    - Instituto Mederi de Pesquisa e Saude Site Number : 0760008
  - Porto Alegre, Rio Grande Do Sul, Brasilien, 90020-090
    - Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760017
  - Porto Alegre, Rio Grande Do Sul, Brasilien, 90160-090
    - Hospital Sao Lucas Site Number : 0760001
- Santa Catarina
  - Blumenau, Santa Catarina, Brasilien, 89030-100
    - HOSPITAL DIA DO PULMAO Site Number : 0760006
  - Florianópolis, Santa Catarina, Brasilien, 88040-970
    - UFSC - Hospital Universitário Site Number : 0760018
- São Paulo
  - Campinas, São Paulo, Brasilien, 13059-900
    - PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760015
  - Santo Andre, São Paulo, Brasilien, 09060-870
    - FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760007
  - Sao Paulo, São Paulo, Brasilien, 01228-000
    - CPQuali Pesquisa Clinica Site Number : 0760003
  - Sao Paulo, São Paulo, Brasilien, 01229-010
    - Instituto de Pesquisa Grupo NotreDame Intermedica Site Number : 0760012
  - Sao Paulo, São Paulo, Brasilien, 04014-002
    - Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760021
  - Sao Paulo, São Paulo, Brasilien, 05403-900
    - InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002
  - Sorocaba, São Paulo, Brasilien, 18040-425
    - Clinica de Alergia Martti Antila Site Number : 0760009
Bulgarien
- - Burgas, Bulgarien, 8000
    - Investigational Site Number : 1005025
  - Dupnitsa, Bulgarien, 2600
    - Investigational Site Number : 1005021
  - Haskovo, Bulgarien, 6305
    - Investigational Site Number : 1005012
  - Montana, Bulgarien, 3403
    - Investigational Site Number : 1005011
  - Plovdiv, Bulgarien, 4002
    - Investigational Site Number : 1005008
  - Ruse, Bulgarien, 70000
    - Investigational Site Number : 1005015
  - Ruse, Bulgarien, 7002
    - Investigational Site Number : 1005013
  - Sofia, Bulgarien, 1000
    - Investigational Site Number : 1005018
  - Sofia, Bulgarien, 1142
    - Investigational Site Number : 1005003
  - Sofia, Bulgarien, 1233
    - Investigational Site Number : 1005001
  - Sofia, Bulgarien, 1233
    - Investigational Site Number : 1005006
  - Sofia, Bulgarien, 1407
    - Investigational Site Number : 1005002
  - Sofia, Bulgarien, 1618
    - Investigational Site Number : 1005026
  - Stara Zagora, Bulgarien, 6000
    - Investigational Site Number : 1005024
  - Stara Zagora, Bulgarien, 6001
    - Investigational Site Number : 1005004
  - Veliko Tyrnovo, Bulgarien, 5000
    - Investigational Site Number : 1005023
  - Veliko Tyrnovo, Bulgarien, 5000
    - Investigational Site Number : 1005027
  - Vidin, Bulgarien, 3700
    - Investigational Site Number : 1005019
  - Vratsa, Bulgarien, 3000
    - Investigational Site Number : 1005020
Canada
- - Quebec, Canada, G1G 3Y8
    - Investigational Site Number : 1240001
  - Quebec, Canada, G2J 0C4
    - Investigational Site Number : 1240005
- Alberta
  - Calgary, Alberta, Canada, T3L 3E6
    - Investigational Site Number : 1240015
- British Columbia
  - Kamloops, British Columbia, Canada, V2C 5T1
    - Investigational Site Number : 1240018
  - Kelowna, British Columbia, Canada, V1Y 4N7
    - Investigational Site Number : 1240017
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 5C4
    - Investigational Site Number : 1240014
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Investigational Site Number : 1240010
  - Sarnia, Ontario, Canada, N7T 4X3
    - Investigational Site Number : 1240009
  - Windsor, Ontario, Canada, N8X 1T3
    - Investigational Site Number : 1240007
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Investigational Site Number : 1240004
  - Québec, Quebec, Canada, G1V 4W2
    - Investigational Site Number : 1240012
Chile
- Los Ríos
  - Valdivia, Los Ríos, Chile, 5110683
    - Investigational Site Number : 1520009
- 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, 7500571
    - Investigational Site Number : 1520007
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500692
    - Investigational Site Number : 1520003
  - Santiago, Reg Metropolitana De Santiago, Chile, 8910131
    - Investigational Site Number : 1520002
- Valparaíso
  - Quillota, Valparaíso, Chile, 2260877
    - Investigational Site Number : 1520004
Colombia
- - Bogota, Colombia, 11001000
    - Investigational Site Number : 1700002
  - Bucaramanga, Colombia
    - Investigational Site Number : 1700007
  - Manizales, Colombia, 170004
    - Investigational Site Number : 1700005
Den Russiske Føderation
- - Moscow, Den Russiske Føderation, 115093
    - Investigational Site Number : 6430001
  - Moscow, Den Russiske Føderation, 115280
    - Investigational Site Number : 6430003
  - Moscow, Den Russiske Føderation, 125284
    - Investigational Site Number : 6430002
  - Nizhny Novgorod, Den Russiske Føderation, 603126
    - Investigational Site Number : 6430009
  - Ryazan, Den Russiske Føderation
    - Investigational Site Number : 6430010
  - Saint Petersburg, Den Russiske Føderation, 198328
    - Investigational Site Number : 6430013
  - Saint Petersburg, Den Russiske Føderation, 928260
    - Investigational Site Number : 6430014
  - St-Petersburg, Den Russiske Føderation, 194354
    - Investigational Site Number : 6430004
  - Stavropol, Den Russiske Føderation, 355020
    - Investigational Site Number : 6430012
  - Tomsk, Den Russiske Føderation, 634034
    - Investigational Site Number : 6430006
  - Ulyanovsk, Den Russiske Føderation, 432017
    - Investigational Site Number : 6430008
  - Voronezh, Den Russiske Føderation, 394066
    - Investigational Site Number : 6430005
Det Forenede Kongerige
- - Aylesbury, Det Forenede Kongerige, HP218AL
    - Investigational Site Number : 8260012
  - Bradford, Det Forenede Kongerige, BD9 6RJ
    - Investigational Site Number : 8260001
  - Bristol, Det Forenede Kongerige, BS10 5NB
    - Investigational Site Number : 8260005
  - Chippenham, Det Forenede Kongerige, SN15 2SB
    - Investigational Site Number : 8260011
  - Derby, Det Forenede Kongerige, DE223NE
    - Investigational Site Number : 8260015
- Cambridgeshire
  - Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 2QQ
    - Investigational Site Number : 8260003
- Lancashire
  - Blackpool, Lancashire, Det Forenede Kongerige, FY3 7DQ
    - Investigational Site Number : 8260002
- Neath Port Talbot
  - Swansea, Neath Port Talbot, Det Forenede Kongerige, SA2 8QA
    - Investigational Site Number : 8260006
- Newcastle Upon Tyne
  - North Shields, Newcastle Upon Tyne, Det Forenede Kongerige, NE29 8NH
    - Investigational Site Number : 8260007
  - South Shields, Newcastle Upon Tyne, Det Forenede Kongerige, NE34 0PL
    - Investigational Site Number : 8260004
- Nottinghamshire
  - Nottingham, Nottinghamshire, Det Forenede Kongerige, NG5 1PB
    - Investigational Site Number : 8260013
Forenede Stater
- Alabama
  - Cullman, Alabama, Forenede Stater, 35055
    - Cullman Research Center, LLC Site Number : 8400095
  - Jasper, Alabama, Forenede Stater, 35501
    - Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090
  - Scottsboro, Alabama, Forenede Stater, 35768
    - Scottsboro Quick Care Clinic Site Number : 8400116
- Arizona
  - Peoria, Arizona, Forenede Stater, 85381
    - Phoenix Medical Group Site Number : 8400061
  - Tempe, Arizona, Forenede Stater, 85283
    - Medical Advancement Center of Arizona Site Number : 8400107
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72209
    - Asthma and Allergy Institute Site Number : 8400022
- California
  - Bakersfield, California, Forenede Stater, 93301
    - Kern Research, Inc Site Number : 8400031
  - Newport Beach, California, Forenede Stater, 92663
    - NewportNativeMD, Inc Site Number : 8400032
  - Rancho Cucamonga, California, Forenede Stater, 91730
    - Prospective Research Innovations, Inc. Site Number : 8400063
  - San Diego, California, Forenede Stater, 92119
    - ACRC Studies Site Number : 8400094
  - San Diego, California, Forenede Stater, 92120
    - Institute of HealthCare Assessment, Inc. Site Number : 8400015
  - Westminster, California, Forenede Stater, 92683
    - Allianz Research Institute Site Number : 8400007
- Colorado
  - Lafayette, Colorado, Forenede Stater, 80026
    - Innovative Clinical Research Site Number : 8400018
- Florida
  - Boynton Beach, Florida, Forenede Stater, 33435
    - Helix Biomedics, LLC Site Number : 8400035
  - Boynton Beach, Florida, Forenede Stater, 33437
    - Pioneer Clinical Research Site Number : 8400043
  - Cape Coral, Florida, Forenede Stater, 33991
    - Renaissance Research and Medical Group, Inc Site Number : 8400092
  - Clearwater, Florida, Forenede Stater, 33765
    - St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020
  - Cutler Bay, Florida, Forenede Stater, 33157
    - Beautiful Minds Clinical Research Center Site Number : 8400081
  - DeBary, Florida, Forenede Stater, 32713
    - Omega Research Consultants, LLC Site Number : 8400021
  - Doral, Florida, Forenede Stater, 33178
    - Sciences Connections, LLC Site Number : 8400133
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - InvesClinic, LLC Site Number : 8400039
  - Greenacres City, Florida, Forenede Stater, 33467
    - Finlay Medical Research Site Number : 8400071
  - Hialeah, Florida, Forenede Stater, 33012
    - Direct Helpers Medical Center Inc Site Number : 8400079
  - Miami, Florida, Forenede Stater, 33155
    - DL Research Solutions Inc Site Number : 8400089
  - Miami, Florida, Forenede Stater, 33165
    - Phoenix Medical Research, LLC Site Number : 8400012
  - Miami, Florida, Forenede Stater, 33174
    - Columbus Clinical Services Site Number : 8400062
  - Miami, Florida, Forenede Stater, 33176
    - Reed Medical Research Site Number : 8400123
  - Miami, Florida, Forenede Stater, 33184
    - De La Cruz Research Center, LLC Site Number : 8400075
  - Orlando, Florida, Forenede Stater, 32825-4454
    - Florida Institute for Clinical Research Site Number : 8400129
  - Orlando, Florida, Forenede Stater, 32825
    - Central Florida Pulmonary Group, PA Site Number : 8400101
  - Palmetto Bay, Florida, Forenede Stater, 33157
    - Innovation Medical Research Center Site Number : 8400114
  - Plant City, Florida, Forenede Stater, 33563
    - Family Medical Specialists of Florida, PA Site Number : 8400077
  - Saint Petersburg, Florida, Forenede Stater, 33704
    - Coastal Pulmonary And Critical Care Site Number : 8400013
  - Winter Park, Florida, Forenede Stater, 32789
    - Florida Pulmonary Research Center Site Number : 8400001
- Georgia
  - Adairsville, Georgia, Forenede Stater, 30103
    - Appalachian Clinical Research Site Number : 8400048
  - Atlanta, Georgia, Forenede Stater, 30345
    - Northlake Medical Group Site Number : 8400099
  - Blue Ridge, Georgia, Forenede Stater, 30513
    - River Birch Research, LLC Site Number : 8400045
  - Conyers, Georgia, Forenede Stater, 30094
    - Medical Centre of Conyers Site Number : 8400064
  - Cordele, Georgia, Forenede Stater, 31015
    - David Kavtaradze MD, Inc. Site Number : 8400135
  - Lawrenceville, Georgia, Forenede Stater, 30046
    - Gwinnett Biomedical Research Site Number : 8400052
  - Rincon, Georgia, Forenede Stater, 31326
    - Southeast Lung Associates Site Number : 8400003
  - Suwanee, Georgia, Forenede Stater, 30024
    - Herman Clinical Research LLC Site Number : 8400078
- Louisiana
  - Crowley, Louisiana, Forenede Stater, 70526
    - Avant Research Associates LLC Site Number : 8400118
- Massachusetts
  - Fall River, Massachusetts, Forenede Stater, 02723
    - Genesis Clinical Research & Consulting Site Number : 8400050
  - South Dartmouth, Massachusetts, Forenede Stater, 02747
    - Infinity Medical Research Site Number : 8400004
- Michigan
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Health System Site Number : 8400053
  - Lathrup Village, Michigan, Forenede Stater, 48076
    - Revive Research Institute Site Number : 8400120
  - Rochester, Michigan, Forenede Stater, 48307
    - Romedica, LLC Site Number : 8400034
  - Saginaw, Michigan, Forenede Stater, 48638
    - Covenant Healthcare Site Number : 8400057
  - Southfield, Michigan, Forenede Stater, 48075-5400
    - Great Lakes Research Institute Site Number : 8400096
- Montana
  - Missoula, Montana, Forenede Stater, 59808
    - Montana Medical Research Site Number : 8400019
- Nebraska
  - Lincoln, Nebraska, Forenede Stater, 68510
    - Somnos Clinical Research Site Number : 8400016
  - Omaha, Nebraska, Forenede Stater, 68114
    - Quality Clinical Research, Inc. Site Number : 8400073
- New Jersey
  - Jersey City, New Jersey, Forenede Stater, 07304
    - Jersey City Breathing Center Site Number : 8400137
- New York
  - E. Amherst, New York, Forenede Stater, 14051
    - WellNow Urgent Care Site Number : 8400132
  - New Hyde Park, New York, Forenede Stater, 11040
    - Northwell Health Site Number : 8400054
  - New Windsor, New York, Forenede Stater, 12553-7754
    - Mid Hudson Medical Research PLLC Site Number : 8400037
  - Westfield, New York, Forenede Stater, 14787
    - Great Lakes Medical Research Site Number : 8400044
- North Carolina
  - Charlotte, North Carolina, Forenede Stater, 28277
    - Onsite Clinical Solutions LLC Site Number : 8400042
  - Gastonia, North Carolina, Forenede Stater, 28054
    - Clinical Research of Gastonia Site Number : 8400010
  - Monroe, North Carolina, Forenede Stater, 28112
    - Monroe Biomedical Research Site Number : 8400087
  - Mooresville, North Carolina, Forenede Stater, 28117
    - Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006
  - Mooresville, North Carolina, Forenede Stater, 28117
    - Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117
  - New Bern, North Carolina, Forenede Stater, 28562
    - Coastal Carolina Health Care, P.A. Site Number : 8400025
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - Southeastern Research Center Site Number : 8400068
- Ohio
  - Columbus, Ohio, Forenede Stater, 43235
    - Optimed Research, LTD Site Number : 8400082
  - Toledo, Ohio, Forenede Stater, 43617
    - Toledo Institute of Clinical Research Site Number : 8400024
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Allergy, Asthma and Clinical Research Center Site Number : 8400127
- Pennsylvania
  - DuBois, Pennsylvania, Forenede Stater, 15801
    - Clinical Research of Central PA Site Number : 8400009
  - Scottdale, Pennsylvania, Forenede Stater, 15683
    - Frontier Clinical Research, LLC Site Number : 8400049
- South Carolina
  - Clinton, South Carolina, Forenede Stater, 29325
    - Carolina Medical Research, LLC Site Number : 8400026
  - Lancaster, South Carolina, Forenede Stater, 29720
    - MD First Research Site Number : 8400105
  - Myrtle Beach, South Carolina, Forenede Stater, 29577
    - LLM Research Site Number : 8400125
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57702
    - Health Concepts Site Number : 8400027
- Tennessee
  - Dickson, Tennessee, Forenede Stater, 37055
    - Pulmonary & Sleep Specialists Site Number : 8400136
  - Franklin, Tennessee, Forenede Stater, 37067
    - Clinical Trials Center of Middle Tennessee Site Number : 8400066
  - Johnson City, Tennessee, Forenede Stater, 37601
    - MultiSpecialty Clinical Research Site Number : 8400110
- Texas
  - Beaumont, Texas, Forenede Stater, 77701
    - REX Clinical Trials Site Number : 8400143
  - Carrollton, Texas, Forenede Stater, 75007
    - Clinrx Research Site Number : 8400059
  - Cypress, Texas, Forenede Stater, 77429
    - Houston Pulmonary and Sleep Associates Site Number : 8400011
  - Houston, Texas, Forenede Stater, 77043-2742
    - Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055
  - Houston, Texas, Forenede Stater, 77054
    - Prolato Clinical Research Center Site Number : 8400128
  - Houston, Texas, Forenede Stater, 77099
    - Pioneer Research Solutions, Inc. Site Number : 8400070
  - Lampasas, Texas, Forenede Stater, 76550-1820
    - Prestige Clinical Research Site Number : 8400029
  - Longview, Texas, Forenede Stater, 75605
    - DCOL Center for Clinical Research Site Number : 8400028
  - McKinney, Texas, Forenede Stater, 75069
    - Metroplex Pulmonary and Sleep Center Site Number : 8400131
  - Plano, Texas, Forenede Stater, 75024
    - Clinrx Research, LLC Site Number : 8400069
  - San Antonio, Texas, Forenede Stater, 78229
    - Diagnostics Research Group Site Number : 8400038
  - Sugar Land, Texas, Forenede Stater, 77479
    - Mt. Olympus Medical Research Site Number : 8400115
- Virginia
  - Abingdon, Virginia, Forenede Stater, 24210
    - Pulmonary Research of Abingdon, LLC Site Number : 8400030
  - Richmond, Virginia, Forenede Stater, 23236
    - Clinical Research Partners Site Number : 8400040
- Wisconsin
  - Greenfield, Wisconsin, Forenede Stater, 53228
    - Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088
Frankrig
- - Bayonne, Frankrig, 64100
    - Investigational Site Number : 2500009
  - Dijon, Frankrig, 21079
    - Investigational Site Number : 2500002
  - Lyon, Frankrig, 69004
    - Investigational Site Number : 2500005
  - Montpellier, Frankrig, 34295
    - Investigational Site Number : 2500003
  - Paris, Frankrig, 75014
    - Investigational Site Number : 2500007
  - Paris, Frankrig, 75015
    - Investigational Site Number : 2500008
  - Pessac, Frankrig, 33600
    - Investigational Site Number : 2500006
  - Saint Herblain, Frankrig, 44800
    - Investigational Site Number : 2500001
Grækenland
- - Athens, Grækenland, 11527
    - Investigational Site Number : 3000001
  - Athens, Grækenland, 10675
    - Investigational Site Number : 3000006
  - Heraklion, Grækenland, 71500
    - Investigational Site Number : 3000003
  - Ioannina, Grækenland, 455 00
    - Investigational Site Number : 3000002
  - Palaio Faliro, Athens, Grækenland, 17562
    - Investigational Site Number : 3000007
  - Thessaloniki, Grækenland, 57010
    - Investigational Site Number : 3000004
Holland
- - Arnhem, Holland, 6815 AD
    - Investigational Site Number : 5280005
  - Breda, Holland, 4818 CK
    - Investigational Site Number : 5280001
  - Dordrecht, Holland, 3318 AT
    - Investigational Site Number : 5280010
  - Harderwijk, Holland, 3844 DG
    - Investigational Site Number : 5280009
  - Leeuwarden, Holland, 8934 AD
    - Investigational Site Number : 5280002
  - Nijmegen, Holland, 6532 SZ
    - Investigational Site Number : 5280006
  - Roermond, Holland, 6043 CV
    - Investigational Site Number : 5280011
  - Zutphen, Holland, 7207 AE
    - Investigational Site Number : 5280008
  - Zwolle, Holland, 8025 AB
    - Investigational Site Number : 5280004
Letland
- - Balvi, Letland, LV-4501
    - Investigational Site Number : 4280008
  - Rezekne, Letland, LV - 4601
    - Investigational Site Number : 4280007
  - Riga, Letland, LV-1002
    - Investigational Site Number : 4280002
  - Riga, Letland, LV -1010
    - Investigational Site Number : 4280001
  - Riga, Letland, LV -1010
    - Investigational Site Number : 4280005
  - Riga, Letland, LV -1021
    - Investigational Site Number : 4280006
  - Riga, Letland, LV-1038
    - Investigational Site Number : 4280003
Litauen
- - Kaunas, Litauen, 44320
    - Investigational Site Number : 4400001
  - Kaunas, Litauen, 49449
    - Investigational Site Number : 4400003
  - Kaunas, Litauen, 50161
    - Investigational Site Number : 4400008
  - Klaipeda, Litauen, 92231
    - Investigational Site Number : 4400007
  - Vilnius, Litauen, 04130
    - Investigational Site Number : 4400005
Mexico
- - Chihuahua, Mexico, 31000
    - Investigational Site Number : 4840010
  - Durango, Mexico, 34000
    - Investigational Site Number : 4840006
  - Mexico City, Mexico, 14050
    - Investigational Site Number : 4840007
  - Mexico City, Mexico, 67000
    - Investigational Site Number : 4840009
  - Veracruz, Mexico, 91910
    - Investigational Site Number : 4840005
- Ciudad De Mexico
  - Benito Juarez, Ciudad De Mexico, Mexico, 03100
    - Investigational Site Number : 4840008
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - Investigational Site Number : 4840002
  - Guadalajara, Jalisco, Mexico, 44670
    - Investigational Site Number : 4840013
  - Zapopan, Jalisco, Mexico, 45070
    - Investigational Site Number : 4840011
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - Investigational Site Number : 4840004
  - Monterrey, Nuevo León, Mexico, 66465
    - Investigational Site Number : 4840003
Peru
- - Lima, Peru, 021
    - Investigational Site Number : 6040006
  - Lima, Peru, 15004
    - Investigational Site Number : 6040004
  - Lima, Peru, LIMA 31
    - Investigational Site Number : 6040001
  - Lima Lima, Peru, Lima 01
    - Investigational Site Number : 6040002
  - Piura, Peru, 20000
    - Investigational Site Number : 6040005
Polen
- - Krakow, Polen, 30-033
    - Investigational Site Number : 6160019
  - Nowa Sol, Polen, 67-100
    - Investigational Site Number : 6160020
- 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
- Podkarpackie
  - Rzeszow, Podkarpackie, Polen, 35-205
    - Investigational Site Number : 6160010
- Podlaskie
  - Bialystok, Podlaskie, Polen, 15-044
    - Investigational Site Number : 6160008
- Slaskie
  - Katowice, Slaskie, Polen, 40-611
    - Investigational Site Number : 6160018
  - Katowice, Slaskie, Polen, 40-648
    - Investigational Site Number : 6160011
- Swietokrzyskie
  - Ostrowiec Swietokrzyski, Swietokrzyskie, Polen, 27-400
    - Investigational Site Number : 6160022
- Warminsko-mazurskie
  - Elblag, Warminsko-mazurskie, Polen, 82-300
    - Investigational Site Number : 6160014
Portugal
- - Almada, Portugal, 2801-951
    - Investigational Site Number : 6200007
  - Aveiro, Portugal, 3810-501
    - Investigational Site Number : 6200006
  - Guimarães, Portugal, 4810-061
    - Investigational Site Number : 6200002
  - Lisboa, Portugal, 1769
    - Investigational Site Number : 6200009
  - Matosinhos, Portugal, 4464-513
    - Investigational Site Number : 6200012
Rumænien
- - Bacau, Rumænien, 600252
    - Investigational Site Number : 6425004
  - Cluj-Napoca, Rumænien, 400275
    - Investigational Site Number : 6425003
  - Constanta, Rumænien, 900002
    - Investigational Site Number : 6425005
  - Iasi, Rumænien, 700732
    - Investigational Site Number : 6425002
  - Pitesti, Rumænien, 110117
    - Investigational Site Number : 6425006
  - Timisoara, Rumænien, 300134
    - Investigational Site Number : 6425001
Serbien
- - Belgrade, Serbien, 11000
    - Investigational Site Number : 6880005
  - Belgrade, Serbien, 11000
    - Investigational Site Number : 6880006
  - Belgrade, Serbien, 11000
    - Investigational Site Number : 6880007
  - Kragujevac, Serbien, 34000
    - Investigational Site Number : 6880003
  - Sremska Kamenica, Serbien, 21204
    - Investigational Site Number : 6880001
  - Valjevo, Serbien, 14000
    - Investigational Site Number : 6880002
Slovakiet
- - Banska Bystrica, Slovakiet, 97401
    - Investigational Site Number : 7030007
  - Humenne, Slovakiet, 066 01
    - Investigational Site Number : 7030006
  - Kosice, Slovakiet, 040 01
    - Investigational Site Number : 7030005
  - 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
- - Málaga, Spanien, 29010
    - Investigational Site Number : 7240010
  - Zaragoza, Spanien, 50009
    - Investigational Site Number : 7240011
- Asturias
  - Oviedo, Asturias, Spanien, 33011
    - Investigational Site Number : 7240007
- Barcelona [Barcelona]
  - Barcelona, Barcelona [Barcelona], Spanien, 08023
    - Investigational Site Number : 7240002
- Catalunya [Cataluña]
  - Badalona, Catalunya [Cataluña], Spanien, 08916
    - Investigational Site Number : 7240009
- Cáceres
  - Caceres, Cáceres, Spanien, 10002
    - Investigational Site Number : 7240012
- Madrid, Comunidad De
  - Madrid, Madrid, Comunidad De, Spanien, 28046
    - Investigational Site Number : 7240003
- Valenciana, Comunidad
  - Valencia, Valenciana, Comunidad, Spanien, 46017
    - Investigational Site Number : 7240008
Sydafrika
- - Benoni, Sydafrika, 1500
    - Investigational Site Number : 7100015
  - Cape Town, Sydafrika, 7500
    - Investigational Site Number : 7100004
  - Chatsworth, Sydafrika, 4091
    - Investigational Site Number : 7100014
  - Durban, Sydafrika, 4071
    - Investigational Site Number : 7100003
  - Durban, Sydafrika, 4001
    - Investigational Site Number : 7100001
  - Durban, Sydafrika, 4001
    - Investigational Site Number : 7100013
  - Durban, Sydafrika, 4302
    - Investigational Site Number : 7100010
  - Gatesville, Sydafrika, 7764
    - Investigational Site Number : 7100002
  - Gauteng, Sydafrika, 1935
    - Investigational Site Number : 7100011
  - Johannesburg, Sydafrika, 0157
    - Investigational Site Number : 7100009
  - Middelburg, Sydafrika, 1050
    - Investigational Site Number : 7100012
  - Parow, Sydafrika, 7500
    - Investigational Site Number : 7100006
  - Pretoria, Sydafrika, 0157
    - Investigational Site Number : 7100005
  - Somerset West, Sydafrika, 7130
    - Investigational Site Number : 7100008
Tjekkiet
- - Havlickuv Brod, Tjekkiet, 580 01
    - Investigational Site Number : 2030009
  - Jihlava, Tjekkiet, 58633
    - Investigational Site Number : 2030004
  - Jindrichuv Hradec III, Tjekkiet, 37701
    - Investigational Site Number : 2030001
  - Kralupy nad Vltavou, Tjekkiet, 278 01
    - Investigational Site Number : 2030007
  - Miroslav, Tjekkiet, 67172
    - Investigational Site Number : 2030003
  - Nymburk, Tjekkiet, 288 01
    - Investigational Site Number : 2030010
  - Strakonice, Tjekkiet, 38601
    - Investigational Site Number : 2030002
Tyskland
- - Berlin, Tyskland, 10961
    - Investigational Site Number : 2760024
  - Berlin, Tyskland, 12159
    - Investigational Site Number : 2760025
  - Darmstadt, Tyskland, 64283
    - Investigational Site Number : 2760017
  - Frankfurt am Main, Tyskland, 60596
    - Investigational Site Number : 2760009
  - Hamburg, Tyskland, 20354
    - Investigational Site Number : 2760002
  - Hannover, Tyskland, 30173
    - Investigational Site Number : 2760003
  - Koblenz, Tyskland, 56068
    - Investigational Site Number : 2760007
  - Leipzig, Tyskland, 04299
    - Investigational Site Number : 2760023
  - Leipzig, Tyskland, 04347
    - Investigational Site Number : 2760011
  - Lübeck, Tyskland, 23552
    - Investigational Site Number : 2760010
  - Mainz, Tyskland, 55128
    - Investigational Site Number : 2760012
  - Marburg, Tyskland, 35043
    - Investigational Site Number : 2760008
  - Peine, Tyskland, 31224
    - Investigational Site Number : 2760020
  - Rosenheim, Tyskland, 83022
    - Investigational Site Number : 2760016
  - Wiesbaden, Tyskland, 65183
    - Investigational Site Number : 2760018
Ukraine
- - Chernivtsi, Ukraine, 58001
    - Investigational Site Number : 8040011
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number : 8040002
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number : 8040003
  - Kharkiv, Ukraine, 61124
    - Investigational Site Number : 8040001
  - Kyiv, Ukraine, 01033
    - Investigational Site Number : 8040007
  - Kyiv, Ukraine, 03049
    - Investigational Site Number : 8040004
  - Lviv, Ukraine, 79011
    - Investigational Site Number : 8040006
  - Ternopil, Ukraine, 46000
    - Investigational Site Number : 8040010
  - Zaporizhzhia, Ukraine, 69076
    - Investigational Site Number : 8040008
  - Zaporizhzhya, Ukraine, 69600
    - Investigational Site Number : 8040009
Ungarn
- - Edelény, Ungarn, 3780
    - Investigational Site Number : 3480003
  - Gödöllö, Ungarn, 2100
    - Investigational Site Number : 3480004
  - Hajdunánás, Ungarn, 4080
    - Investigational Site Number : 3480002
  - Mosonmagyaróvár, Ungarn, 9200
    - Investigational Site Number : 3480006
  - Szombathely, Ungarn, 9700
    - Investigational Site Number : 3480005
  - Százhalombatta, Ungarn, 2440
    - Investigational Site Number : 3480001

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 85 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 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.
Deltagere med aktuel diagnose af astma i henhold til Global Initiative for Astma (GINA) retningslinjer eller dokumenteret astmahistorie.
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.
Langtidsbehandling med ilt >4,0 l/min ELLER hvis en deltager kræver mere end 2,0 l/min for at opretholde iltmætning >88 %
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 Dupilumab administreret hver anden uge	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 Placebo dosis indgivet hver 2. uge	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

Dupilumab administreret hver anden uge

Medicin: Dupilumab SAR231893

Lægemiddelform: Injektionsvæske, opløsning

Administrationsvej: Subkutan

Andre navne:

Dupixent

Medicin: Inhaleret kortikosteroid