En 52-ugers, placebo- og aktiv-kontrolleret (Roflumilast, Daliresp® 500 µg) undersøgelse for at evaluere effektiviteten og sikkerheden af to doser CHF6001 DPI (Tanimilast) som tilføjelse til vedligeholdelses-tripleterapi hos personer med KOL og kronisk bronkitis. (SØJLE) (PILLAR)
30. januar 2026 opdateret af: Chiesi Farmaceutici S.p.A.
En 52-ugers, randomiseret, dobbelt-blind, dobbelt-dummy, placebo- og aktiv-kontrolleret (Roflumilast, Daliresp® 500 µg), parallel gruppe, undersøgelse til evaluering af effektiviteten og sikkerheden af to doser CHF6001 DPI-tillæg til vedligeholdelse Tredobbelt terapi hos personer med kronisk obstruktiv lungesygdom (KOL) og kronisk bronkitis.
Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af to doser CHF6001 (Tanimilast) som tilføjelse til vedligeholdelsestripelbehandling i målpatientpopulationen.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
3973
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina
- Chiesi Clinical Trial - Site 32502
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Buenos Aires, Argentina
- Chiesi Clinical Trial - Site 32510
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Buenos Aires, Argentina
- Chiesi Clinical Trial - Site 32515
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Buenos Aires, Argentina
- Chiesi Clinical Trial - Site 32565
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Ciudad Autonoma Buenos Aires, Argentina
- Chiesi Clinical Trial - Site 32514
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Ciudad Autonoma Buenos Aires, Argentina
- Chiesi Clinical Trial - Site 32567
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Ciudad Autónoma de Buenos Aire, Argentina
- Chiesi Clinical Trial - Site 32507
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Concepción del Uruguay, Argentina
- Chiesi Clinical Trial - Site 32563
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Córdoba, Argentina
- Chiesi Clinical Trial - Site 32503
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Córdoba, Argentina
- Chiesi Clinical Trial - Site 32509
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Florida, Argentina
- Chiesi Clinical Trial - Site 32501
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Mar del Plata, Argentina
- Chiesi Clinical Trial - Site 32562
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Mendoza, Argentina
- Chiesi Clinical Trial - Site 32505
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Mendoza, Argentina
- Chiesi Clinical Trial - Site 32511
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Mendoza, Argentina
- Chiesi Clinical Trial - Site 32513
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Quilmes, Argentina
- Chiesi Clinical Trial - Site 32506
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Rosario, Argentina
- Chiesi Clinical Trial - Site 32553
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San Juan Bautista, Argentina
- Chiesi Clinical Trial - Site 32508
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San Miguel de Tucumán, Argentina
- Chiesi Clinical Trial - Site 32512
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San Miguel de Tucumán, Argentina
- Chiesi Clinical Trial - Site 32551
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San Miguel de Tucumán, Argentina
- Chiesi Clinical Trial - Site 32561
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San Miguel de Tucumán, Argentina
- Chiesi Clinical Trial - Site 32564
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San Rafael, Argentina
- Chiesi Clinical Trial - Site 32566
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Santa Fe, Argentina
- Chiesi Clinical Trial - Site 32556
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Banja Luka, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70553
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Bihać, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70555
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Bijeljina, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70554
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Foča, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70557
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Gradiška, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70556
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Mostar, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70560
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Mostar, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70562
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Sarajevo, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70559
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Sarajevo, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70561
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Travnik, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70551
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Trebinje, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70558
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Tuzla, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70563
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Zenica, Bosnien-Hercegovina
- Chiesi Clinical Trial - Site 70552
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Blagoevgrad, Bulgarien
- Chiesi Clinical Trial - Site 100535
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Dimitrovgrad, Bulgarien
- Chiesi Clinical Trial - Site 100534
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Gabrovo, Bulgarien
- Chiesi Clinical Trial - Site 100525
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Haskovo, Bulgarien
- Chiesi Clinical Trial - Site 100523
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Kozloduy, Bulgarien
- Chiesi Clinical Trial - Site 100533
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Lovech, Bulgarien
- Chiesi Clinical Trial - Site 100527
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Montana, Bulgarien
- Chiesi Clinical Trial - Site 100515
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Pernik, Bulgarien
- Chiesi Clinical Trial - Site 100532
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Pleven, Bulgarien
- Chiesi Clinical Trial - Site 100522
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Plovdiv, Bulgarien
- Chiesi Clinical Trial - Site 100529
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Razgrad, Bulgarien
- Chiesi Clinical Trial - Site 100537
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Rousse, Bulgarien
- Chiesi Clinical Trial - Site 100512
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Rousse, Bulgarien
- Chiesi Clinical Trial - Site 100516
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Sevlievo, Bulgarien
- Chiesi Clinical Trial - Site 100536
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100501
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100509
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100514
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100517
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100518
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100530
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100531
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Sofia, Bulgarien
- Chiesi Clinical Trial - Site 100538
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Stara Zagora, Bulgarien
- Chiesi Clinical Trial - Site 100524
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Vidin, Bulgarien
- Chiesi Clinical Trial - Site 100519
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Vidin, Bulgarien
- Chiesi Clinical Trial - Site 100557
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-
-
-
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Concepción, Chile
- Chiesi Clinical Trial - Site 152506
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Quillota, Chile
- Chiesi Clinical Trial - Site 152507
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Santiago, Chile
- Chiesi Clinical Trial - Site 152503
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Santiago, Chile
- Chiesi Clinical Trial - Site 152504
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Santiago, Chile
- Chiesi Clinical Trial - Site 152508
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Talca, Chile
- Chiesi Clinical Trial - Site 152509
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Valparaíso, Chile
- Chiesi Clinical Trial - Site 152501
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-
-
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Belfast, Det Forenede Kongerige
- Chiesi Clinical Trial - Site 826510
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Bradford, Det Forenede Kongerige
- Chiesi Clinical Trial - Site 826509
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London, Det Forenede Kongerige
- Chiesi Clinical Trial - Site 826511
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Rochdale, Det Forenede Kongerige
- Chiesi Clinical Trial - Site 826512
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-
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Narva, Estland
- Chiesi Clinical Trial - Site 372553
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Tallinn, Estland
- Chiesi Clinical Trial - Site 372551
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Tartu, Estland
- Chiesi Clinical Trial - Site 372552
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Alabama
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Andalusia, Alabama, Forenede Stater, 36420-5310
- Chiesi Clinical Trial - Site 840635
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Foley, Alabama, Forenede Stater, 36535-2248
- Chiesi Clinical Trial - Site 840614
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Guntersville, Alabama, Forenede Stater, 35976-2206
- Chiesi Clinical Trial - Site 840670
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Mobile, Alabama, Forenede Stater, 36608
- Chiesi Clinical Trial - Site 840720
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Saraland, Alabama, Forenede Stater, 36571-3014
- Chiesi Clinical Trial - Site 840643
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Arizona
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Phoenix, Arizona, Forenede Stater, 85018-5434
- Chiesi Clinical Trial - Site 840638
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Arkansas
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Conway, Arkansas, Forenede Stater, 72032
- Chiesi Clinical Trial - Site 840684
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California
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Laguna Hills, California, Forenede Stater, 92653-5509
- Chiesi Clinical Trial - Site 840675
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Los Angeles, California, Forenede Stater, 90017-5649
- Chiesi Clinical Trial - Site 840666
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Newport Beach, California, Forenede Stater, 92663-3661
- Chiesi Clinical Trial - Site 840511
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Northridge, California, Forenede Stater, 91324-6200
- Chiesi Clinical Trial - Site 840680
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Northridge, California, Forenede Stater, 91324
- Chiesi Clinical Trial - Site 840605
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Pomona, California, Forenede Stater, 91768
- Chiesi Clinical Trial - Site 840700
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Westminster, California, Forenede Stater, 92708
- Chiesi Clinical Trial - Site 840531
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Colorado
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Centennial, Colorado, Forenede Stater, 80112-1406
- Chiesi Clinical Trial - Site 840636
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Lakewood, Colorado, Forenede Stater, 80228
- Chiesi Clinical Trial - Site 840688
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Florida
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Brooksville, Florida, Forenede Stater, 34613
- Chiesi Clinical Trial - Site 840735
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Chiefland, Florida, Forenede Stater, 32626
- Chiesi Clinical Trial - Site 840513
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Clearwater, Florida, Forenede Stater, 33756
- Chiesi Clinical Trial - Site 840652
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Clearwater, Florida, Forenede Stater, 33765-2103
- Chiesi Clinical Trial - Site 840569
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Coral Gables, Florida, Forenede Stater, 33135
- Chiesi Clinical Trial - Site 840545
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Cutler Bay, Florida, Forenede Stater, 33144-2566
- Chiesi Clinical Trial - Site 840603
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Cutler Bay, Florida, Forenede Stater, 33189-1230
- Chiesi Clinical Trial - Site 840587
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Cutler Bay, Florida, Forenede Stater, 33189
- Chiesi Clinical Trial - Site 840568
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Daytona Beach, Florida, Forenede Stater, 33470-9216
- Chiesi Clinical Trial - Site840539
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DeBary, Florida, Forenede Stater, 32713-2260
- Chiesi Clinical Trial - Site 840554
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Doral, Florida, Forenede Stater, 33014-2426
- Chiesi Clinical Trial - Site 840625
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Doral, Florida, Forenede Stater, 33122-1902
- Chiesi Clinical Trial - Site 840572
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Hialeah, Florida, Forenede Stater, 33010-4103
- Chiesi Clinical Trial - Site 840685
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Hialeah, Florida, Forenede Stater, 33012-3618
- Chiesi Clinical Trial - Site 840504
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Hialeah, Florida, Forenede Stater, 33015-2952
- Chiesi Clinical Trial - Site 840639
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Hialeah, Florida, Forenede Stater, 33015-6003
- Chiesi Clinical Trial - Site 840582
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Hialeah, Florida, Forenede Stater, 33016-2753
- Chiesi Clinical Trial - Site 840617
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Hialeah, Florida, Forenede Stater, 33186-5331
- Chiesi Clinical Trial - Site 840514
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Hialeah Gardens, Florida, Forenede Stater, 33016
- Chiesi Clinical Trial - Site 840637
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Hollywood, Florida, Forenede Stater, 33021
- Chiesi Clinical Trial - Site 840509
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Hollywood, Florida, Forenede Stater, 33024
- Chiesi Clinical Trial - Site 840730
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Homestead, Florida, Forenede Stater, 33256
- Chiesi Clinical Trial - Site 840565
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Loxahatchee Groves, Florida, Forenede Stater, 33470
- Chiesi Clinical Trial - Site 840674
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Melbourne, Florida, Forenede Stater, 32934
- Chiesi Clinical Trial - Site 840732
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Miami, Florida, Forenede Stater, 33125-5114
- Chiesi Clinical Trial - Site 840624
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Miami, Florida, Forenede Stater, 33126-1921
- Chiesi Clinical Trial - Site 840596
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Miami, Florida, Forenede Stater, 33126-1926
- Chiesi Clinical Trial - Site 840556
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Miami, Florida, Forenede Stater, 33135-2967
- Chiesi Clinical Trial - Site 840602
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Miami, Florida, Forenede Stater, 33144-2100
- Chiesi Clinical Trial - Site 840507
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Miami, Florida, Forenede Stater, 33144-4273
- Chiesi Clinical Trial - Site 840519
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Miami, Florida, Forenede Stater, 33144-5037
- Chiesi Clinical Trial - Site 840505
-
Miami, Florida, Forenede Stater, 33144
- Chiesi Clinical Trial - Site 840644
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Miami, Florida, Forenede Stater, 33155-1694
- Chiesi Clinical Trial - Site 840557
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Miami, Florida, Forenede Stater, 33155-4630
- Chiesi Clinical Trial - Site 840588
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Miami, Florida, Forenede Stater, 33155-6538
- Chiesi Clinical Trial - Site 840618
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Miami, Florida, Forenede Stater, 33155-6541
- Chiesi Clinical Trial - Site 840525
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Miami, Florida, Forenede Stater, 33155-6542
- Chiesi Clinical Trial - Site 840656
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Miami, Florida, Forenede Stater, 33155
- Chiesi Clinical Trial - Site 840622
-
Miami, Florida, Forenede Stater, 33165-2075
- Chiesi Clinical Trial - Site 840537
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Miami, Florida, Forenede Stater, 33165-2470
- Chiesi Clinical Trial - Site 840691
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Miami, Florida, Forenede Stater, 33175-3598
- Chiesi Clinical Trial - Site 840503
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Miami, Florida, Forenede Stater, 33184-1176
- Chiesi Clinical Trial - Site 840694
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Miami, Florida, Forenede Stater, 33185
- Chiesi Clinical Trial - Site 840630
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Miami Gardens, Florida, Forenede Stater, 33014-6426
- Chiesi Clinical Trial - Site 840506
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Miami Lakes, Florida, Forenede Stater, 33014-2425
- Chiesi Clinical Trial - Site 840608
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Orlando, Florida, Forenede Stater, 32807-3555
- Chiesi Clinical Trial - Site 840524
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Orlando, Florida, Forenede Stater, 32825
- Chiesi Clinical Trial - Site 840563
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Pembroke Pines, Florida, Forenede Stater, 14000
- Chiesi Clinical Trial - Site 840702
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Pembroke Pines, Florida, Forenede Stater, 33024-3618
- Chiesi Clinical Trial - Site 840502
-
Pembroke Pines, Florida, Forenede Stater, 33024-6442
- Chiesi Clinical Trial - Site 840550
-
Pompano Beach, Florida, Forenede Stater, 33064-3547
- Chiesi Clinical Trial - Site 840527
-
South Miami, Florida, Forenede Stater, 33143-4960
- Chiesi Clinical Trial - Site 840654
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St. Petersburg, Florida, Forenede Stater, 33707-6129
- Chiesi Clinical Trial - Site 840699
-
St. Petersburg, Florida, Forenede Stater, 33713-8900
- Chiesi Clinical Trial - Site 840697
-
Tampa, Florida, Forenede Stater, 33613-3740
- Chiesi Clinical Trial - Site 840567
-
Winter Park, Florida, Forenede Stater, 32789
- Chiesi Clinical Trial - Site 840632
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-
Georgia
-
Adairsville, Georgia, Forenede Stater, 30103-2438
- Chiesi Clinical Trial - Site 840542
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College Park, Georgia, Forenede Stater, 30349
- Chiesi Clinical Trial - Site 840728
-
Columbus, Georgia, Forenede Stater, 31904
- Chiesi Clinical Trial - Site 840717
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Cordele, Georgia, Forenede Stater, 31015
- Chiesi Clinical Trial - Site 840710
-
East Point, Georgia, Forenede Stater, 30344
- Chiesi Clinical Trial - Site 840689
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Stonecrest, Georgia, Forenede Stater, 30038
- Chiesi Clinical Trial - Site 840726
-
Valdosta, Georgia, Forenede Stater, 31605-1096
- Chiesi Clinical Trial - Site 840564
-
-
Indiana
-
Muncie, Indiana, Forenede Stater, 46303
- Chiesi Clinical Trial - Site 840724
-
-
Louisiana
-
Zachary, Louisiana, Forenede Stater, 70791-4010
- Chiesi Clinical Trial - Site 840672
-
-
Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Chiesi Clinical Trial - Site 840645
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Baltimore, Maryland, Forenede Stater, 21224-6821
- Chiesi Clinical Trial - Site 840661
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-
Massachusetts
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North Dartmouth, Massachusetts, Forenede Stater, 02747-1271
- Chiesi Clinical Trial - Site 840707
-
-
Michigan
-
Troy, Michigan, Forenede Stater, 48085
- Chiesi Clinical Trial - Site 840657
-
-
Mississippi
-
Port Gibson, Mississippi, Forenede Stater, 39150
- Chiesi Clinical Trial - Site 840658
-
-
Missouri
-
Saint Charles, Missouri, Forenede Stater, 63301-2835
- Chiesi Clinical Trial - Site 840641
-
St Louis, Missouri, Forenede Stater, 63110
- Chiesi Clinical Trial - Site 840714
-
St Louis, Missouri, Forenede Stater, 63141
- Chiesi Clinical Trial - Site 840541
-
St Louis, Missouri, Forenede Stater, 63141
- Chiesi Clinical Trial - Site 840669
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68178
- Chiesi Clinical Trial - Site 840686
-
-
Nevada
-
Henderson, Nevada, Forenede Stater, 89052
- Chiesi Clinical Trial - Site 840703
-
Las Vegas, Nevada, Forenede Stater, 89106-4159
- Chiesi Clinical Trial - Site 840529
-
North Las Vegas, Nevada, Forenede Stater, 89030-7193
- Chiesi Clinical Trial - Site 840701
-
-
New Jersey
-
Bayonne, New Jersey, Forenede Stater, 07002
- Chiesi Clinical Trial - Site 840722
-
-
New York
-
Buffalo, New York, Forenede Stater, 14203-1070
- Chiesi Clinical Trial - Site 840667
-
New Windsor, New York, Forenede Stater, 12553-7754
- Chiesi Clinical Trial - Site 840678
-
New York, New York, Forenede Stater, 10021-0005
- Chiesi Clinical Trial - Site 840520
-
New York, New York, Forenede Stater, 10029-6500
- Chiesi Clinical Trial - Site 840705
-
The Bronx, New York, Forenede Stater, 10455
- Chiesi Clinical Trial - Site 840626
-
The Bronx, New York, Forenede Stater, 10468-6401
- Chiesi Clinical Trial - Site 840604
-
-
North Carolina
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Charlotte, North Carolina, Forenede Stater, 28210-0106
- Chiesi Clinical Trial - Site 840664
-
Charlotte, North Carolina, Forenede Stater, 28273
- Chiesi Clinical Trial - Site 840721
-
Denver, North Carolina, Forenede Stater, 28037-7930
- Chiesi Clinical Trial - Site 840610
-
Gastonia, North Carolina, Forenede Stater, 28054-7481
- Chiesi Clinical Trial - Site 840659
-
Huntersville, North Carolina, Forenede Stater, 28078-5082
- Chiesi Clinical Trial - Site 840540
-
New Bern, North Carolina, Forenede Stater, 28562-5238
- Chiesi Clinical Trial - Site 840523
-
Shelby, North Carolina, Forenede Stater, 28150
- Chiesi Clinical Trial - Site 840708
-
Winston-Salem, North Carolina, Forenede Stater, 27103
- Chiesi Clinical Trial - Site 840621
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45236
- Chiesi Clinical Trial - Site 840627
-
Columbus, Ohio, Forenede Stater, 43228
- Chiesi Clinical Trial - Site 840713
-
Dayton, Ohio, Forenede Stater, 45419-4336
- Chiesi Clinical Trial - Site 840647
-
Toledo, Ohio, Forenede Stater, 43617-1178
- Chiesi Clinical Trial - Site 840646
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- Chiesi Clinical Trial - Site 840668
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Tulsa, Oklahoma, Forenede Stater, 74133-5829
- Chiesi Clinical Trial - Site 840692
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107-5109
- Chiesi Clinical Trial - Site 840671
-
Philadelphia, Pennsylvania, Forenede Stater, 19140
- Chiesi Clinical Trial - Site 840683
-
-
South Carolina
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Anderson, South Carolina, Forenede Stater, 29621-4822
- Chiesi Clinical Trial - Site 840578
-
Charleston, South Carolina, Forenede Stater, 29412-2625
- Chiesi Clinical Trial - Site 840592
-
Fort Mill, South Carolina, Forenede Stater, 29701
- Chiesi Clinical Trial - Site 840528
-
North Charleston, South Carolina, Forenede Stater, 29420
- Chiesi Clinical Trial - Site 840598
-
Rock Hill, South Carolina, Forenede Stater, 29732-1160
- Chiesi Clinical Trial - Site 840696
-
-
Tennessee
-
Franklin, Tennessee, Forenede Stater, 37067
- Chiesi Clinical Trial - Site 840660
-
Franklin, Tennessee, Forenede Stater, 38305
- Chiesi Clinical Trial - Site 840546
-
Knoxville, Tennessee, Forenede Stater, 37909-1161
- Chiesi Clinical Trial - Site 840553
-
-
Texas
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Baytown, Texas, Forenede Stater, 77521-2416
- Chiesi Clinical Trial - Site 840535
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Boerne, Texas, Forenede Stater, 78006-1993
- Chiesi Clinical Trial - Site 840634
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Carrollton, Texas, Forenede Stater, 14000
- Chiesi Clinical Trial - Site 840704
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Cypress, Texas, Forenede Stater, 77429-4696
- Chiesi Clinical Trial - Site 840566
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Dallas, Texas, Forenede Stater, 75246
- Chiesi Clinical Trial - Site 840706
-
Houston, Texas, Forenede Stater, 77008
- Chiesi Clinical Trial - Site 840716
-
Houston, Texas, Forenede Stater, 77030
- Chiesi Clinical Trial - Site 840698
-
Kerrville, Texas, Forenede Stater, 78028-9640
- Chiesi Clinical Trial - Site 840574
-
McKinney, Texas, Forenede Stater, 75069
- Chiesi Clinical Trial - Site 840551
-
Mesquite, Texas, Forenede Stater, 75149-2438
- Chiesi Clinical Trial - Site 840575
-
North Richland Hills, Texas, Forenede Stater, 76180-7319
- Chiesi Clinical Trial - Site 840741
-
Pearland, Texas, Forenede Stater, 77584-7401
- Chiesi Clinical Trial - Site 840663
-
Plano, Texas, Forenede Stater, 75025
- Chiesi Clinical Trial - Site 840609
-
San Antonio, Texas, Forenede Stater, 78215-1528
- Chiesi Clinical Trial - Site 840673
-
San Antonio, Texas, Forenede Stater, 78229
- Chiesi Clinical Trial - Site 840681
-
San Antonio, Texas, Forenede Stater, 78229
- Chiesi Clinical Trial - Site 840711
-
San Antonio, Texas, Forenede Stater, 78229
- Chiesi Clinical Trial - Site 840729
-
San Antonio, Texas, Forenede Stater, 78258
- Chiesi Clinical Trial - Site 840597
-
Sherman, Texas, Forenede Stater, 75092-7351
- Chiesi Clinical Trial - Site 840600
-
Sugar Land, Texas, Forenede Stater, 77479-3481
- Chiesi Clinical Trial - Site 840552
-
Tomball, Texas, Forenede Stater, 77373
- Chiesi Clinical Trial - Site 840526
-
-
Virginia
-
Portsmouth, Virginia, Forenede Stater, 23703
- Chiesi Clinical Trial - Site 840693
-
-
Washington
-
Everett, Washington, Forenede Stater, 98208
- Chiesi Clinical Trial - Site 840709
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26505-0423
- Chiesi Clinical Trial - Site 840562
-
-
Wisconsin
-
Greenfield, Wisconsin, Forenede Stater, 53228-3467
- Chiesi Clinical Trial - Site 840532
-
-
-
-
-
Athens, Grækenland
- Chiesi Clinical Trial - Site 300506
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Chortiatis, Grækenland
- Chiesi Clinical Trial - Site 300504
-
Heraklion, Grækenland
- Chiesi Clinical Trial - Site 300501
-
Ioannina, Grækenland
- Chiesi Clinical Trial - Site 300503
-
Thessaloniki, Grækenland
- Chiesi Clinical Trial - Site 300505
-
Volos, Grækenland
- Chiesi Clinical Trial - Site 300507
-
-
-
-
-
Beek, Holland
- Chiesi Clinical Trial - Site 528501
-
Breda, Holland
- Chiesi Clinical Trial - Site 528504
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Heerlen, Holland
- Chiesi Clinical Trial - Site 528502
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Leeuwarden, Holland
- Chiesi Clinical Trial - Site 528505
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-
-
-
-
Ashkelon, Israel
- Chiesi Clinical Trial - Site 376502
-
Beersheba, Israel
- Chiesi Clinical Trial - Site 376501
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Hadera, Israel
- Chiesi Clinical Trial - Site 376511
-
Haifa, Israel
- Chiesi Clinical Trial - Site 376508
-
Haifa, Israel
- Chiesi Clinical Trial - Site 376510
-
Jerusalem, Israel
- Chiesi Clinical Trial - Site 376503
-
Jerusalem, Israel
- Chiesi Clinical Trial - Site 376506
-
Kfar Saba, Israel
- Chiesi Clinical Trial - Site 376507
-
Ramat Gan, Israel
- Chiesi Clinical Trial - Site 376504
-
Tel Aviv, Israel
- Chiesi Clinical Trial - Site 376509
-
-
-
-
-
Dubrovnik, Kroatien
- Chiesi Clinical Trial - Site 191562
-
Karlovac, Kroatien
- Chiesi Clinical Trial - Site 191552
-
Osijek, Kroatien
- Chiesi Clinical Trial - Site 191557
-
Rijeka, Kroatien
- Chiesi Clinical Trial - Site 191561
-
Rijeka, Kroatien
- Chiesi Clinical Trial - Site 191563
-
Sisak, Kroatien
- Chiesi Clinical Trial - Site 191553
-
Split, Kroatien
- Chiesi Clinical Trial - Site 191558
-
Zadar, Kroatien
- Chiesi Clinical Trial - Site 191555
-
Zagreb, Kroatien
- Chiesi Clinical Trial - Site 191551
-
Zagreb, Kroatien
- Chiesi Clinical Trial - Site 191554
-
Zagreb, Kroatien
- Chiesi Clinical Trial - Site 191556
-
Zagreb, Kroatien
- Chiesi Clinical Trial - Site 191559
-
Zagreb, Kroatien
- Chiesi Clinical Trial - Site 191560
-
-
-
-
-
Balvi, Letland
- Chiesi Clinical Trial - Site 371557
-
Daugavpils, Letland
- Chiesi Clinical Trial - Site 371553
-
Daugavpils, Letland
- Chiesi Clinical Trial - Site 371554
-
Jūrmala, Letland
- Chiesi Clinical Trial - Site 371555
-
Riga, Letland
- Chiesi Clinical Trial - Site 371551
-
Riga, Letland
- Chiesi Clinical Trial - Site 371552
-
Riga, Letland
- Chiesi Clinical Trial - Site 371556
-
Rēzekne, Letland
- Chiesi Clinical Trial - Site 371558
-
-
-
-
-
Chihuahua City, Mexico
- Chiesi Clinical Trial - Site 484502
-
Chihuahua City, Mexico
- Chiesi Clinical Trial - Site 484510
-
Cuauhtémoc, Mexico
- Chiesi Clinical Trial - Site 484506
-
Córdoba, Mexico
- Chiesi Clinical Trial - Site 484505
-
Guadalajara, Mexico
- Chiesi Clinical Trial - Site 484501
-
Guadalajara, Mexico
- Chiesi Clinical Trial - Site 484507
-
Guadalajara, Mexico
- Chiesi Clinical Trial - Site 484509
-
Monterrey, Mexico
- Chiesi Clinical Trial - Site 484503
-
Monterrey, Mexico
- Chiesi Clinical Trial - Site 484511
-
Veracruz, Mexico
- Chiesi Clinical Trial - Site 484504
-
-
-
-
-
Christchurch, New Zealand
- Chiesi Clinical Trial - Site 554504
-
Hamilton, New Zealand
- Chiesi Clinical Trial - Site 554502
-
Tauranga, New Zealand
- Chiesi Clinical Trial - Site 554503
-
-
-
-
-
Bitola, Nordmakedonien
- Chiesi Clinical Trial - Site 807555
-
Gevgelija, Nordmakedonien
- Chiesi Clinical Trial - Site 807559
-
Ohrid, Nordmakedonien
- Chiesi Clinical Trial - Site 807557
-
Shtip, Nordmakedonien
- Chiesi Clinical Trial - Site 807553
-
Skopje, Nordmakedonien
- Chiesi Clinical Trial - Site 807552
-
Skopje, Nordmakedonien
- Chiesi Clinical Trial - Site 807554
-
Skopje, Nordmakedonien
- Chiesi Clinical Trial - Site 807556
-
-
-
-
-
Bialystok, Polen
- Chiesi Clinical Trial - Site 616518
-
Giżycko, Polen
- Chiesi Clinical Trial - Site 616504
-
Katowice, Polen
- Chiesi Clinical Trial - Site 616515
-
Katowice, Polen
- Chiesi Clinical Trial - Site 616522
-
Krakow, Polen
- Chiesi Clinical Trial - Site 616509
-
Krakow, Polen
- Chiesi Clinical Trial - Site 616511
-
Krakow, Polen
- Chiesi Clinical Trial - Site 616514
-
Lodz, Polen
- Chiesi Clinical Trial - Site 616503
-
Lodz, Polen
- Chiesi Clinical Trial - Site 616523
-
Ostrowiec Świętokrzyski, Polen
- Chiesi Clinical Trial - Site 616519
-
Poznan, Polen
- Chiesi Clinical Trial - Site 616506
-
Poznan, Polen
- Chiesi Clinical Trial - Site 616508
-
Sosnowiec, Polen
- Chiesi Clinical Trial - Site 616501
-
Torun, Polen
- Chiesi Clinical Trial - Site 616502
-
Wroclaw, Polen
- Chiesi Clinical Trial - Site 616554
-
-
-
-
-
Bacau, Rumænien
- Chiesi Clinical Trial - Site 642510
-
Brasov, Rumænien
- Chiesi Clinical Trial - Site 642551
-
Cluj-Napoca, Rumænien
- Chiesi Clinical Trial - Site 642502
-
Cluj-Napoca, Rumænien
- Chiesi Clinical Trial - Site 642504
-
Cluj-Napoca, Rumænien
- Chiesi Clinical Trial - Site 642512
-
Cluj-Napoca, Rumænien
- Chiesi Clinical Trial - Site 642554
-
Cluj-Napoca Cluj, Rumænien
- Chiesi Clinical Trial - Site 642506
-
Cluj-Napoca Cluj, Rumænien
- Chiesi Clinical Trial - Site 642508
-
Constanța, Rumænien
- Chiesi Clinical Trial - Site 642501
-
Craiova, Rumænien
- Chiesi Clinical Trial - Site 642509
-
Craiova, Rumænien
- Chiesi Clinical Trial - Site 642511
-
Iași, Rumænien
- Chiesi Clinical Trial - Site 642514
-
Oradea, Rumænien
- Chiesi Clinical Trial - Site 642503
-
Reșca, Rumænien
- Chiesi Clinical Trial - Site 642513
-
Timișoara, Rumænien
- Chiesi Clinical Trial - Site 642505
-
Timișoara, Rumænien
- Chiesi Clinical Trial - Site 642507
-
Timișoara, Rumænien
- Chiesi Clinical Trial - Site 642515
-
-
-
-
-
Kazan', Rusland
- Chiesi Clinical Trial - Site 643517
-
Moscow, Rusland
- Chiesi Clinical Trial - Site 643513
-
Moscow, Rusland
- Chiesi Clinical Trial - Site 643528
-
Nizhny Novgorod, Rusland
- Chiesi Clinical Trial - Site 643516
-
Odintsovskiy, Rusland
- Chiesi Clinical Trial - Site 643503
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643504
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643505
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643506
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643508
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643510
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643511
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643512
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643514
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643519
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643520
-
Saint Petersburg, Rusland
- Chiesi Clinical Trial - Site 643531
-
Saratov, Rusland
- Chiesi Clinical Trial - Site 643515
-
Saratov, Rusland
- Chiesi Clinical Trial - Site 643525
-
Ulyanovsk, Rusland
- Chiesi Clinical Trial - Site 643521
-
Voronezh, Rusland
- Chiesi Clinical Trial - Site 643502
-
Vsevolozhsk, Rusland
- Chiesi Clinical Trial - Site 643524
-
Yaroslavl, Rusland
- Chiesi Clinical Trial - Site 643507
-
Yaroslavl, Rusland
- Chiesi Clinical Trial - Site 643518
-
-
-
-
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688552
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688553
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688555
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688557
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688558
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688559
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688561
-
Belgrade, Serbien
- Chiesi Clinical Trial - Site 688569
-
Jagodina, Serbien
- Chiesi Clinical Trial - Site 688570
-
Kamenitz, Serbien
- Chiesi Clinical Trial - Site 688564
-
Kamenitz, Serbien
- Chiesi Clinical Trial - Site 688566
-
Kragujevac, Serbien
- Chiesi Clinical Trial - Site 688556
-
Leskovac, Serbien
- Chiesi Clinical Trial - Site 688562
-
Niš, Serbien
- Chiesi Clinical Trial - Site 688554
-
Niš, Serbien
- Chiesi Clinical Trial - Site 688568
-
Pančevo, Serbien
- Chiesi Clinical Trial - Site 688567
-
Paraćin, Serbien
- Chiesi Clinical Trial - Site 688560
-
Sombor, Serbien
- Chiesi Clinical Trial - Site 688551
-
Sremska Mitrovica, Serbien
- Chiesi Clinical Trial - Site 688571
-
Užice, Serbien
- Chiesi Clinical Trial - Site 688563
-
Valjevo, Serbien
- Chiesi Clinical Trial - Site 688565
-
-
-
-
-
Bardejov, Slovakiet
- Chiesi Clinical Trial - Site 703501
-
Košice, Slovakiet
- Chiesi Clinical Trial - Site 703503
-
Spišská Nová Ves, Slovakiet
- Chiesi Clinical Trial - Site 703502
-
-
-
-
-
Barcelona, Spanien
- Chiesi Clinical Trial - Site 724503
-
Córdoba, Spanien
- Chiesi Clinical Trial - Site 724501
-
Madrid, Spanien
- Chiesi Clinical Trial - Site 724505
-
Madrid, Spanien
- Chiesi Clinical Trial - Site 724551
-
Majadahonda, Spanien
- Chiesi Clinical Trial - Site 724504
-
Zaragoza, Spanien
- Chiesi Clinical Trial - Site 724502
-
-
-
-
-
Anyang-si, Sydkorea
- Chiesi Clinical Trial - Site 408556
-
Daegu, Sydkorea
- Chiesi Clinical Trial - Site 408551
-
Dongjak, Sydkorea
- Chiesi Clinical Trial - Site 408560
-
Gwangju, Sydkorea
- Chiesi Clinical Trial - Site 408554
-
Haeundae, Sydkorea
- Chiesi Clinical Trial - Site 408559
-
Incheon, Sydkorea
- Chiesi Clinical Trial - Site 408557
-
Incheon, Sydkorea
- Chiesi Clinical Trial - Site 408558
-
Jeonju, Sydkorea
- Chiesi Clinical Trial - Site 408555
-
Seoul, Sydkorea
- Chiesi Clinical Trial - Site 408552
-
Seoul, Sydkorea
- Chiesi Clinical Trial - Site 408553
-
Suwon,Gyeonggi-do, Sydkorea
- Chiesi Clinical Trial - Site 408561
-
-
-
-
-
Brandýs nad Labem, Tjekkiet
- Chiesi Clinical Trial - Site 203551
-
Havlíčkův Brod, Tjekkiet
- Chiesi Clinical Trial - Site 203518
-
Jindřichův Hradec, Tjekkiet
- Chiesi Clinical Trial - Site 203501
-
Miroslav, Tjekkiet
- Chiesi Clinical Trial - Site 203504
-
Mladá Boleslav, Tjekkiet
- Chiesi Clinical Trial - Site 203516
-
Měšice, Tjekkiet
- Chiesi Clinical Trial - Site 203517
-
Prague, Tjekkiet
- Chiesi Clinical Trial - Site 203505
-
Prague, Tjekkiet
- Chiesi Clinical Trial - Site 203507
-
Prague, Tjekkiet
- Chiesi Clinical Trial - Site 203513
-
Prague, Tjekkiet
- Chiesi Clinical Trial - Site 203515
-
-
-
-
-
Adana, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792512
-
Bornova, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792510
-
Istanbul, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792507
-
Kocaeli, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792514
-
Mersin, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792513
-
Pamukkale, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792506
-
Pendik, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792508
-
Yenişehir, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792511
-
Çanakkale, Tyrkiet (Türkiye)
- Chiesi Clinical Trial - Site 792551
-
-
-
-
-
Berlin, Tyskland
- Chiesi Clinical Trial - Site 276505
-
Berlin, Tyskland
- Chiesi Clinical Trial - Site 276506
-
Berlin, Tyskland
- Chiesi Clinical Trial - Site 276510
-
Berlin, Tyskland
- Chiesi Clinical Trial - Site 276511
-
Berlin, Tyskland
- Chiesi Clinical Trial - Site 276515
-
Cottbus, Tyskland
- Chiesi Clinical Trial - Site 276556
-
Darmstadt, Tyskland
- Chiesi Clinical Trial - Site 276509
-
Delitzsch, Tyskland
- Chiesi Clinical Trial - Site 276503
-
Frankfurt am Main, Tyskland
- Chiesi Clinical Trial - Site 276504
-
Geesthacht, Tyskland
- Chiesi Clinical Trial - Site 276557
-
Hamburg, Tyskland
- Chiesi Clinical Trial - Site 276501
-
Hamburg, Tyskland
- Chiesi Clinical Trial - Site 276513
-
Hamburg, Tyskland
- Chiesi Clinical Trial - Site 276514
-
Hanover, Tyskland
- Chiesi Clinical Trial - Site 276558
-
Koblenz, Tyskland
- Chiesi Clinical Trial - Site 276517
-
Leipzig, Tyskland
- Chiesi Clinical Trial - Site 276502
-
Leipzig, Tyskland
- Chiesi Clinical Trial - Site 276516
-
Leipzig, Tyskland
- Chiesi Clinical Trial - Site 276551
-
Mainz, Tyskland
- Chiesi Clinical Trial - Site 276507
-
Munich, Tyskland
- Chiesi Clinical Trial - Site 276508
-
Peine, Tyskland
- Chiesi Clinical Trial - Site 276518
-
-
-
-
-
Dnipro, Ukraine
- Chiesi Clinical Trial - Site 804522
-
Ivano-Frankivsk, Ukraine
- Chiesi Clinical Trial - Site 804502
-
Kharkiv, Ukraine
- Chiesi Clinical Trial - Site 804504
-
Kharkiv, Ukraine
- Chiesi Clinical Trial - Site 804505
-
Kharkiv, Ukraine
- Chiesi Clinical Trial - Site 804506
-
Kharkiv, Ukraine
- Chiesi Clinical Trial - Site 804509
-
Kherson, Ukraine
- Chiesi Clinical Trial - Site 804503
-
Kiev, Ukraine
- Chiesi Clinical Trial - Site 804511
-
Kremenchuk, Ukraine
- Chiesi Clinical Trial - Site 804520
-
Kyiv, Ukraine
- Chiesi Clinical Trial - Site 804501
-
Kyiv, Ukraine
- Chiesi Clinical Trial - Site 804508
-
Kyiv, Ukraine
- Chiesi Clinical Trial - Site 804512
-
Kyiv, Ukraine
- Chiesi Clinical Trial - Site 804516
-
Kyiv, Ukraine
- Chiesi Clinical Trial - Site 804518
-
Kyiv, Ukraine
- Chiesi Clinical Trial - Site 804521
-
Odesa, Ukraine
- Chiesi Clinical Trial - Site 804527
-
Poltava, Ukraine
- Chiesi Clinical Trial - Site 804507
-
Vinnytsia, Ukraine
- Chiesi Clinical Trial - Site 804515
-
Vinnytsia, Ukraine
- Chiesi Clinical Trial - Site 804517
-
Zaporizhia, Ukraine
- Chiesi Clinical Trial - Site 804528
-
-
-
-
-
Balassagyarmat, Ungarn
- Chiesi Clinical Trial - Site 348506
-
Budapest, Ungarn
- Chiesi Clinical Trial - Site 348501
-
Csorna, Ungarn
- Chiesi Clinical Trial - Site 348505
-
Edelény, Ungarn
- Chiesi Clinical Trial - Site 348512
-
Gödöllő, Ungarn
- Chiesi Clinical Trial - Site 348508
-
Monor, Ungarn
- Chiesi Clinical Trial - Site 348509
-
Nyíregyháza, Ungarn
- Chiesi Clinical Trial - Site 348507
-
Pécs, Ungarn
- Chiesi Clinical Trial - Site 348513
-
Sellye, Ungarn
- Chiesi Clinical Trial - Site 348552
-
Szeged, Ungarn
- Chiesi Clinical Trial - Site 348510
-
Szombathely, Ungarn
- Chiesi Clinical Trial - Site 348503
-
Törökbálint, Ungarn
- Chiesi Clinical Trial - Site 348515
-
-
-
-
-
Feldbach, Østrig
- Chiesi Clinical Trial - Site 40502
-
Grieskirchen, Østrig
- Chiesi Clinical Trial - Site 40504
-
Linz, Østrig
- Chiesi Clinical Trial - Site 40501
-
Linz, Østrig
- Chiesi Clinical Trial - Site 40503
-
Wels, Østrig
- Chiesi Clinical Trial - Site 40505
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Voksne i alderen ≥ 40 år, med KOL og med kronisk bronkitis.
- Nuværende rygere eller tidligere rygere (historie på ≥10 pakkeår).
- Post-bronkodilatator FEV1 <50 % af patienten forudsagde normal værdi og FEV1/FVC ratio < 0,7.
- Mindst én moderat eller svær KOL-eksacerbation i det foregående år.
- CAT-score ≥10.
- Personer i regelmæssig vedligeholdelses-tredobbeltbehandling i mindst 12 måneder.
Ekskluderingskriterier:
- Personer med aktuel astma.
- Forsøgspersoner med moderat eller svær KOL-eksacerbation 4 uger før studiestart og randomisering
- Personer med kendt α-1-antitrypsinmangel som den underliggende årsag til KOL.
- Personer med KOL-emfysem eller blandede fænotyper.
- Personer med andre kendte luftvejslidelser end KOL.
- Forsøgspersoner med lungevolumenreduktionskirurgi.
- Personer med aktiv kræft eller en historie med lungekræft.
- Forsøgspersoner under Roflumilast-behandling inden for 6 måneder før studiestart.
- Personer med diagnosen depression, generaliseret angstlidelse, selvmordstanker.
- Personer med klinisk signifikant kardiovaskulær tilstand.
- Forsøgspersoner med neurologisk sygdom.
- Personer med klinisk signifikante laboratorieabnormiteter.
- Personer med moderat eller svær leverinsufficiens.
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
CHF6001 matchende placebo, 2 inhalationer bud og Roflumilast matchende placebo, 1 tablet én gang dagligt
|
|
Eksperimentel: CHF6001 1600µg
|
CHF6001 400 µg, 2 inhalationer bid (samlet daglig dosis på 1600 µg) og Roflumilast matchende placebo, 1 tablet én gang dagligt
|
|
Eksperimentel: CHF6001 3200µg
|
CHF6001 800 µg, 2 inhalationer bid (samlet daglig dosis på 3200 µg) og Roflumilast matchende placebo, 1 tablet én gang dagligt
|
|
Aktiv komparator: Roflumilast
|
- 1 tablet Roflumilast (Daliresp®), 250 µg, én gang dagligt i løbet af de første 4 ugers behandling, derefter 1 tablet Roflumilast (Daliresp®), 500 µg, én gang dagligt i den resterende behandlingsperiode og CHF6001 matchende placebo, 2 inhalationer bud
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antallet af moderate og svære eksacerbationer, der forekommer i løbet af den planlagte 52-ugers behandlingsperiode.
Tidsramme: Op til 52 uger
|
Moderat eller svær eksacerbation er defineret ved symptomatisk forværring af KOL:
|
Op til 52 uger
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tiden til den første moderate eller svære eksacerbation.
Tidsramme: Op til 52 uger
|
Tiden til den første moderate eller svære eksacerbation.
|
Op til 52 uger
|
|
Den årlige rate af alvorlige eksacerbationer.
Tidsramme: Op til 52 uger
|
Den årlige rate af alvorlige eksacerbationer.
|
Op til 52 uger
|
|
Tiden til den første alvorlige eksacerbation.
Tidsramme: Op til 52 uger
|
Tiden til den første alvorlige eksacerbation.
|
Op til 52 uger
|
|
Antallet af alle alvorlige eksacerbationer under behandling.
Tidsramme: Op til 52 uger
|
Antallet af alle alvorlige eksacerbationer under behandling.
|
Op til 52 uger
|
|
Antallet af alle eksacerbationer under behandling, der kræver systemiske kortikosteroider.
Tidsramme: Op til 52 uger
|
Antallet af alle eksacerbationer under behandling, der kræver systemiske kortikosteroider.
|
Op til 52 uger
|
|
Ændring fra baseline (før-dosis besøg 2) i præ-dosis FEV1 i uge 52.
Tidsramme: I uge 52
|
Ændring fra baseline (før-dosis besøg 2) i præ-dosis FEV1 i uge 52.
|
I uge 52
|
|
Ændring fra baseline i Saint Georges Respiratory Questionnaire (SGRQ) total og domænescore i uge 52.
Tidsramme: I uge 52
|
Ændring fra baseline i Saint Georges Respiratory Questionnaire (SGRQ) total og domænescore i uge 52.
|
I uge 52
|
|
Saint Georges Respiratory Questionnaire-svar (SGRQ) (ændring fra baseline SGRQ total score ≤ -4) i uge 52.
Tidsramme: I uge 52
|
Saint Georges Respiratory Questionnaire-svar (SGRQ) (ændring fra baseline SGRQ total score ≤ -4) i uge 52.
|
I uge 52
|
|
Ændring fra baseline til sidste inter-besøgsperiode (uge 40-52) i EXACT-respiratoriske symptomer (E-RS) Total- og subskala-score.
Tidsramme: Op til 52 uger
|
Ændring fra baseline til sidste inter-besøgsperiode (uge 40-52) i EXACT-respiratoriske symptomer (E-RS) Total- og subskala-score.
|
Op til 52 uger
|
|
E-RS-respons (ændring fra baseline E-RS Total score ≤ -2) i uge 52.
Tidsramme: I uge 52
|
E-RS-respons (ændring fra baseline E-RS Total score ≤ -2) i uge 52.
|
I uge 52
|
|
Ændring fra baseline til sidste inter-besøgsperiode (uge 40-52) i procentdelen af dage uden indtagelse af redningsmedicin og i den gennemsnitlige redningsmedicinbrug (antal pust).
Tidsramme: Op til 52 uger
|
Ændring fra baseline til sidste interbesøgsperiode (uge 40-52) i procentdelen af dage
|
Op til 52 uger
|
|
Tid til at studere medicinafbrydelse uanset årsag.
Tidsramme: Op til 52 uger
|
Tid til at studere medicinafbrydelse uanset årsag.
|
Op til 52 uger
|
|
Tid til moderat eller alvorlig eksacerbation eller seponering af undersøgelsesmedicin på grund af enhver uønsket hændelse, manglende effekt eller død (sammensat endepunkt) og tid til at undersøge komponenten for seponering af medicin.
Tidsramme: Op til 52 uger
|
Tid til moderat eller alvorlig eksacerbation eller seponering af undersøgelsesmedicin på grund af enhver uønsket hændelse, manglende effekt eller død (sammensat endepunkt) og tid til at undersøge komponenten for seponering af medicin.
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Op til 52 uger
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Tid til første moderat/alvorlig eksacerbation eller seponering af undersøgelsesmedicin på grund af enhver klasserelateret AE, manglende effekt eller død (sammensat endepunkt) og tid til at undersøge komponenten for seponering af medicin.
Tidsramme: Op til 52 uger
|
Tid til første moderat/alvorlig eksacerbation eller seponering af undersøgelsesmedicin på grund af enhver klasserelateret AE, manglende effekt eller død (sammensat endepunkt) og tid til at undersøge komponenten for seponering af medicin.
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Op til 52 uger
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Sekundær nøglevariabel: Ændring fra baseline i SGRQ Total score i uge 52
Tidsramme: I uge 52
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Sekundær nøglevariabel: Ændring fra baseline i SGRQ Total score i uge 52
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I uge 52
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Fernando J. MARTINEZ, Prof., Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. juli 2021
Primær færdiggørelse (Faktiske)
23. december 2025
Studieafslutning (Faktiske)
23. december 2025
Datoer for studieregistrering
Først indsendt
16. november 2020
Først indsendt, der opfyldte QC-kriterier
16. november 2020
Først opslået (Faktiske)
19. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. februar 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. januar 2026
Sidst verificeret
1. januar 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CLI-06001AA1-05
- 2020-003648-97 (EudraCT nummer)
- 2023-510174-13-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .