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Uno studio che valuta l'efficacia dell'inalatore dosato con budesonide, glicopirronio e formoterolo fumarato sugli esiti cardiopolmonari nella malattia polmonare ostruttiva cronica (THARROS)

1 ottobre 2026 aggiornato da: AstraZeneca

Uno studio randomizzato, in doppio cieco, a gruppi paralleli, multicentrico, di fase III per valutare l'efficacia dell'inalatore a dose dosata di budesonide, glicopirronio e formoterolo fumarato rispetto a glicopirronio e formoterolo fumarato MDI sugli esiti cardiopolmonari nella malattia polmonare ostruttiva cronica (THARROS)

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Panoramica dello studio

Descrizione dettagliata

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

Tipo di studio

Interventistico

Iscrizione (Stimato)

5250

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Buenos Aires, Argentina, C1425BEN
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      • Buenos Aires, Argentina, C1012AAR
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      • Buenos Aires, Argentina, 1425
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      • CABA, Argentina, C1019ABS
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      • Ciudad Autónoma de Bs As, Argentina, C1182ACD
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      • Ciudad de Buenos Aires, Argentina, C1414AIF
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      • Ciudad de Buenos Aires, Argentina, C1425AGC
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      • Florida, Argentina, B1602DQD
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      • Mar del Plata, Argentina, B7600GWV
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      • Mendoza, Argentina, M5500CCG
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      • Ranelagh, Argentina, 1886
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      • Rosario, Argentina, 2000
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      • San Fernando, Argentina, B1646EBJ
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      • San Juan Bautista, Argentina, 1888
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      • San Miguel de Tucumán, Argentina, 4000
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      • San Miguel de Tucumán, Argentina, T4000CBC
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      • Birtinya, Australia, 4575
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      • Cairns, Australia, 4870
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      • Chermside, Australia, 4032
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      • Coffs Harbour, Australia, 02450
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      • Dubbo, Australia, 2830
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      • Nedlands, Australia, 6009
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      • Port Macquarie, Australia, 2444
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      • Spearwood, Australia, 6163
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      • St Albans, Australia, 3021
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      • St Albans, Australia, 3021
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      • Waitara, Australia, 2077
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      • Wangaratta, Australia, 3677
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      • Bad Ischl, Austria, 4820
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      • Braunau am Inn, Austria, 5280
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      • Feldbach, Austria, 8330
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      • Curitiba, Brasile, 80030-110
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      • Fortaleza, Brasile, 60125-000
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      • Ijuí, Brasile, 98700-000
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      • Juiz de Fora, Brasile, 36033-318
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      • Mossoró, Brasile, 59603-020
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      • Passo Fundo, Brasile, 99010-120
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      • Montreal, Quebec, Canada, H4A 3J1
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      • Saskatoon, Saskatchewan, Canada, S7N 0W8
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      • Jindřichův Hradec, Cechia, 377 01
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      • Olomouc, Cechia, 772 00
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      • Olomouc, Cechia, 772 00
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      • Ostrava, Cechia, 702 00
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      • Prague, Cechia, 110 00
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      • Prague, Cechia, 140 46
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      • Curicó, Chile, 3341643
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      • Quillota, Chile, 2260000
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      • Santiago, Chile, 7750495
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      • Santiago, Chile, 7691236
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      • Santiago, Chile, 7500691
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      • Talca, Chile, 3465584
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      • Victoria, Chile, 4720097
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      • Beijing, Cina, 10730
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      • Changsha, Cina, 410005
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      • Hangzhou, Cina, 310006
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      • Hefei, Cina, 230000
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      • Benito Juárez, Messico, 03650
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      • El Agustino, Perù, LIMA 10
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      • Bialystok, Polonia, 15-879
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        • Reclutamento
        • Research Site
      • Kragujevac, Serbia, 34000
        • Reclutamento
        • Research Site
      • Niš, Serbia, 18108
        • Reclutamento
        • Research Site
      • Novi Sad, Serbia, 21000
        • Reclutamento
        • Research Site
      • Bratislava, Slovacchia, 949 01
        • Reclutamento
        • Research Site
      • Brezno, Slovacchia, 977 01
        • Reclutamento
        • Research Site
      • Humenné, Slovacchia, 066 01
        • Reclutamento
        • Research Site
      • Košice, Slovacchia, 04022
        • Reclutamento
        • Research Site
      • Kráľovský Chlmec, Slovacchia, 077 01
        • Ritirato
        • Research Site
      • Levice, Slovacchia, 93401
        • Reclutamento
        • Research Site
      • Prešov, Slovacchia, 081 81
        • Ritirato
        • Research Site
      • Topoľčany, Slovacchia, 955 01
        • Reclutamento
        • Research Site
      • Alicante, Spagna, 03010
        • Reclutamento
        • Research Site
      • Badia Del Vallès, Spagna, 08214
        • Reclutamento
        • Research Site
      • Barakaldo, Spagna, 48903
        • Ritirato
        • Research Site
      • Barcelona, Spagna, 08840
        • Reclutamento
        • Research Site
      • Barcelona, Spagna, 08017
        • Terminato
        • Research Site
      • Castro Urdiales, Spagna, 39700
        • Reclutamento
        • Research Site
      • Córdoba, Spagna, 14940
        • Reclutamento
        • Research Site
      • Granada, Spagna, 18014
        • Reclutamento
        • Research Site
      • Madrid, Spagna, 28031
        • Reclutamento
        • Research Site
      • Marbella (Málaga), Spagna, 29603
        • Reclutamento
        • Research Site
      • Mataró, Spagna, 08302
        • Ritirato
        • Research Site
      • Mataró, Spagna, 08303
        • Reclutamento
        • Research Site
      • Málaga, Spagna, 29010
        • Reclutamento
        • Research Site
      • Palma, Spagna, 07011
        • Reclutamento
        • Research Site
      • Patraix, Spagna, 46017
        • Reclutamento
        • Research Site
      • Santa Cruz de Tenerife, Spagna, 38010
        • Ritirato
        • Research Site
      • Santiago de Compostela-Coruña, Spagna, 15706
        • Reclutamento
        • Research Site
    • Alabama
      • Athens, Alabama, Stati Uniti, 35611
        • Terminato
        • Research Site
      • Cullman, Alabama, Stati Uniti, 35058
        • Reclutamento
        • Research Site
      • Fairhope, Alabama, Stati Uniti, 36532
        • Terminato
        • Research Site
      • Huntsville, Alabama, Stati Uniti, 35801
        • Terminato
        • Research Site
      • Mobile, Alabama, Stati Uniti, 36608
        • Reclutamento
        • Research Site
      • Sheffield, Alabama, Stati Uniti, 35660
        • Ritirato
        • Research Site
    • Arizona
      • Gilbert, Arizona, Stati Uniti, 85296
        • Reclutamento
        • Research Site
      • Glendale, Arizona, Stati Uniti, 85308
        • Ritirato
        • Research Site
      • Mesa, Arizona, Stati Uniti, 85206
        • Reclutamento
        • Research Site
      • Mesa, Arizona, Stati Uniti, 85213
        • Reclutamento
        • Research Site
      • Phoenix, Arizona, Stati Uniti, 85006
        • Terminato
        • Research Site
      • Tempe, Arizona, Stati Uniti, 85283
        • Terminato
        • Research Site
      • Tempe, Arizona, Stati Uniti, 85281
        • Sospeso
        • Research Site
      • Tucson, Arizona, Stati Uniti, 85715
        • Reclutamento
        • Research Site
      • Tucson, Arizona, Stati Uniti, 85710
        • Reclutamento
        • Research Site
    • California
      • Apple Valley, California, Stati Uniti, 92307
        • Ritirato
        • Research Site
      • Canoga Park, California, Stati Uniti, 91303
        • Sospeso
        • Research Site
      • Castroville, California, Stati Uniti, 95012
        • Reclutamento
        • Research Site
      • Garden Grove, California, Stati Uniti, 92844
        • Reclutamento
        • Research Site
      • Gardena, California, Stati Uniti, 90247
        • Terminato
        • Research Site
      • Inglewood, California, Stati Uniti, 90301
        • Reclutamento
        • Research Site
      • La Mesa, California, Stati Uniti, 91942
        • Reclutamento
        • Research Site
      • La Palma, California, Stati Uniti, 90623
        • Reclutamento
        • Research Site
      • Lomita, California, Stati Uniti, 90717
        • Reclutamento
        • Research Site
      • Long Beach, California, Stati Uniti, 90815
        • Reclutamento
        • Research Site
      • Los Alamitos, California, Stati Uniti, 90720
        • Terminato
        • Research Site
      • Mission Viejo, California, Stati Uniti, 92691
        • Reclutamento
        • Research Site
      • Newport Beach, California, Stati Uniti, 92663
        • Reclutamento
        • Research Site
      • North Hollywood, California, Stati Uniti, 91602
        • Terminato
        • Research Site
      • Pomona, California, Stati Uniti, 91768
        • Reclutamento
        • Research Site
      • Sacramento, California, Stati Uniti, 95823
        • Reclutamento
        • Research Site
      • Sacramento, California, Stati Uniti, 95831
        • Reclutamento
        • Research Site
      • San Bernardino, California, Stati Uniti, 92408
        • Terminato
        • Research Site
      • San Diego, California, Stati Uniti, 92111
        • Terminato
        • Research Site
      • San Dimas, California, Stati Uniti, 91773
        • Ritirato
        • Research Site
      • Santa Ana, California, Stati Uniti, 92704
        • Ritirato
        • Research Site
      • Tarzana, California, Stati Uniti, 91356
        • Reclutamento
        • Research Site
      • Thousand Oaks, California, Stati Uniti, 91360
        • Reclutamento
        • Research Site
      • Van Nuys, California, Stati Uniti, 91405
        • Ritirato
        • Research Site
      • Vista, California, Stati Uniti, 92081
        • Reclutamento
        • Research Site
      • Westminster, California, Stati Uniti, 92683
        • Sospeso
        • Research Site
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80012
        • Reclutamento
        • Research Site
      • Denver, Colorado, Stati Uniti, 80228
        • Reclutamento
        • Research Site
      • Englewood, Colorado, Stati Uniti, 80110
        • Terminato
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20016
        • Terminato
        • Research Site
    • Florida
      • Boynton Beach, Florida, Stati Uniti, 33435
        • Reclutamento
        • Research Site
      • Bradenton, Florida, Stati Uniti, 34209
        • Reclutamento
        • Research Site
      • Cape Coral, Florida, Stati Uniti, 33990
        • Reclutamento
        • Research Site
      • Clearwater, Florida, Stati Uniti, 33765
        • Reclutamento
        • Research Site
      • Clearwater, Florida, Stati Uniti, 33756
        • Reclutamento
        • Research Site
      • Crystal River, Florida, Stati Uniti, 34429
        • Reclutamento
        • Research Site
      • Cutler Bay, Florida, Stati Uniti, 33189
        • Sospeso
        • Research Site
      • Edgewater, Florida, Stati Uniti, 32132
        • Reclutamento
        • Research Site
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Reclutamento
        • Research Site
      • Fort Myers, Florida, Stati Uniti, 33912
        • Terminato
        • Research Site
      • Hialeah, Florida, Stati Uniti, 33012
        • Terminato
        • Research Site
      • Hialeah, Florida, Stati Uniti, 33013
        • Terminato
        • Research Site
      • Hollywood, Florida, Stati Uniti, 33024
        • Reclutamento
        • Research Site
      • Homestead, Florida, Stati Uniti, 33033
        • Reclutamento
        • Research Site
      • Kissimmee, Florida, Stati Uniti, 34746
        • Reclutamento
        • Research Site
      • Kissimmee, Florida, Stati Uniti, 34741
        • Ritirato
        • Research Site
      • Lake City, Florida, Stati Uniti, 32055
        • Reclutamento
        • Research Site
      • Lake City, Florida, Stati Uniti, 32055
        • Terminato
        • Research Site
      • Lake Worth, Florida, Stati Uniti, 33467
        • Reclutamento
        • Research Site
      • Lakeland, Florida, Stati Uniti, 33813
        • Reclutamento
        • Research Site
      • Lakeland, Florida, Stati Uniti, 33805
        • Reclutamento
        • Research Site
      • Loxahatchee Groves, Florida, Stati Uniti, 33470
        • Ritirato
        • Research Site
      • Miami, Florida, Stati Uniti, 33175
        • Reclutamento
        • Research Site
      • Miami, Florida, Stati Uniti, 33175
        • Terminato
        • Research Site
      • Miami, Florida, Stati Uniti, 33155
        • Reclutamento
        • Research Site
      • Miami Lakes, Florida, Stati Uniti, 33016
        • Reclutamento
        • Research Site
      • Naples, Florida, Stati Uniti, 34102
        • Reclutamento
        • Research Site
      • Ocala, Florida, Stati Uniti, 34470
        • Reclutamento
        • Research Site
      • Orlando, Florida, Stati Uniti, 32807
        • Reclutamento
        • Research Site
      • Orlando, Florida, Stati Uniti, 32819
        • Reclutamento
        • Research Site
      • Orlando, Florida, Stati Uniti, 32825
        • Reclutamento
        • Research Site
      • Ormond Beach, Florida, Stati Uniti, 32174
        • Reclutamento
        • Research Site
      • Pembroke Pines, Florida, Stati Uniti, 33024
        • Sospeso
        • Research Site
      • Plantation, Florida, Stati Uniti, 33324
        • Reclutamento
        • Research Site
      • St. Petersburg, Florida, Stati Uniti, 33713
        • Reclutamento
        • Research Site
      • St. Petersburg, Florida, Stati Uniti, 33713
        • Sospeso
        • Research Site
      • Sun City Center, Florida, Stati Uniti, 33573
        • Terminato
        • Research Site
      • Tamarac, Florida, Stati Uniti, 33321
        • Reclutamento
        • Research Site
      • Tamarac, Florida, Stati Uniti, 33321
        • Sospeso
        • Research Site
      • Tampa, Florida, Stati Uniti, 33606
        • Reclutamento
        • Research Site
      • Tampa, Florida, Stati Uniti, 33607
        • Sospeso
        • Research Site
      • Tampa, Florida, Stati Uniti, 33625
        • Terminato
        • Research Site
    • Georgia
      • Fayetteville, Georgia, Stati Uniti, 30214
        • Terminato
        • Research Site
      • Peachtree Corners, Georgia, Stati Uniti, 30092
        • Ritirato
        • Research Site
      • Savannah, Georgia, Stati Uniti, 31406
        • Reclutamento
        • Research Site
      • Tucker, Georgia, Stati Uniti, 30084
        • Reclutamento
        • Research Site
    • Idaho
      • Boise, Idaho, Stati Uniti, 83706
        • Terminato
        • Research Site
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60607
        • Reclutamento
        • Research Site
      • Winfield, Illinois, Stati Uniti, 60190
        • Reclutamento
        • Research Site
    • Indiana
      • Valparaiso, Indiana, Stati Uniti, 46383
        • Reclutamento
        • Research Site
    • Iowa
      • Sioux City, Iowa, Stati Uniti, 51106
        • Reclutamento
        • Research Site
    • Kansas
      • Newton, Kansas, Stati Uniti, 67114
        • Terminato
        • Research Site
      • Wichita, Kansas, Stati Uniti, 67218
        • Reclutamento
        • Research Site
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40503
        • Reclutamento
        • Research Site
      • Paducah, Kentucky, Stati Uniti, 42001
        • Terminato
        • Research Site
    • Louisiana
      • Lafayette, Louisiana, Stati Uniti, 70508
        • Reclutamento
        • Research Site
      • Monroe, Louisiana, Stati Uniti, 71201
        • Reclutamento
        • Research Site
      • Shreveport, Louisiana, Stati Uniti, 71105
        • Reclutamento
        • Research Site
      • Zachary, Louisiana, Stati Uniti, 70791
        • Reclutamento
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, Stati Uniti, 21061
        • Ritirato
        • Research Site
      • Oxon Hill, Maryland, Stati Uniti, 20745
        • Reclutamento
        • Research Site
      • Potomac, Maryland, Stati Uniti, 20854
        • Terminato
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Reclutamento
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • Reclutamento
        • Research Site
      • Flint, Michigan, Stati Uniti, 48504
        • Reclutamento
        • Research Site
      • Southfield, Michigan, Stati Uniti, 48075
        • Reclutamento
        • Research Site
      • Southfield, Michigan, Stati Uniti, 48034
        • Reclutamento
        • Research Site
    • Mississippi
      • Gulfport, Mississippi, Stati Uniti, 39503
        • Reclutamento
        • Research Site
      • Olive Branch, Mississippi, Stati Uniti, 38654
        • Reclutamento
        • Research Site
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64116
        • Sospeso
        • Research Site
      • Liberty, Missouri, Stati Uniti, 64068
        • Ritirato
        • Research Site
      • St Louis, Missouri, Stati Uniti, 63104
        • Reclutamento
        • Research Site
      • St Louis, Missouri, Stati Uniti, 63136
        • Terminato
        • Research Site
    • Montana
      • Missoula, Montana, Stati Uniti, 59808
        • Reclutamento
        • Research Site
    • Nebraska
      • Fremont, Nebraska, Stati Uniti, 68025
        • Reclutamento
        • Research Site
      • Grand Island, Nebraska, Stati Uniti, 68803
        • Reclutamento
        • Research Site
      • Lincoln, Nebraska, Stati Uniti, 68510
        • Ritirato
        • Research Site
      • Omaha, Nebraska, Stati Uniti, 68134
        • Terminato
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89101
        • Reclutamento
        • Research Site
      • Las Vegas, Nevada, Stati Uniti, 89102
        • Terminato
        • Research Site
      • Las Vegas, Nevada, Stati Uniti, 89119
        • Terminato
        • Research Site
      • Las Vegas, Nevada, Stati Uniti, 89121
        • Reclutamento
        • Research Site
    • New Jersey
      • Lawrence, New Jersey, Stati Uniti, 08648
        • Ritirato
        • Research Site
      • Mullica Hill, New Jersey, Stati Uniti, 08062
        • Reclutamento
        • Research Site
      • Toms River, New Jersey, Stati Uniti, 08755
        • Reclutamento
        • Research Site
      • Union City, New Jersey, Stati Uniti, 07087
        • Ritirato
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87109
        • Ritirato
        • Research Site
    • New York
      • Albany, New York, Stati Uniti, 12205
        • Reclutamento
        • Research Site
      • Albany, New York, Stati Uniti, 12208
        • Ritirato
        • Research Site
      • Bronxville, New York, Stati Uniti, 10708
        • Ritirato
        • Research Site
      • Brooklyn, New York, Stati Uniti, 11220
        • Terminato
        • Research Site
      • Massapequa, New York, Stati Uniti, 11758
        • Reclutamento
        • Research Site
      • New Windsor, New York, Stati Uniti, 12553
        • Reclutamento
        • Research Site
      • New York, New York, Stati Uniti, 10036
        • Reclutamento
        • Research Site
      • New York, New York, Stati Uniti, 10065
        • Reclutamento
        • Research Site
      • The Bronx, New York, Stati Uniti, 10455
        • Reclutamento
        • Research Site
      • Vestal, New York, Stati Uniti, 13850
        • Terminato
        • Research Site
    • North Carolina
      • Fayetteville, North Carolina, Stati Uniti, 28303
        • Terminato
        • Research Site
      • Greensboro, North Carolina, Stati Uniti, 27405
        • Reclutamento
        • Research Site
      • Greenville, North Carolina, Stati Uniti, 27834
        • Reclutamento
        • Research Site
      • Huntersville, North Carolina, Stati Uniti, 28078
        • Reclutamento
        • Research Site
      • Morehead City, North Carolina, Stati Uniti, 28557
        • Reclutamento
        • Research Site
      • Raleigh, North Carolina, Stati Uniti, 27612
        • Sospeso
        • Research Site
      • Salisbury, North Carolina, Stati Uniti, 28144
        • Terminato
        • Research Site
      • Statesville, North Carolina, Stati Uniti, 28625
        • Reclutamento
        • Research Site
      • Statesville, North Carolina, Stati Uniti, 28677
        • Ritirato
        • Research Site
      • Wilmington, North Carolina, Stati Uniti, 28412
        • Terminato
        • Research Site
      • Winston-Salem, North Carolina, Stati Uniti, 27104
        • Reclutamento
        • Research Site
    • Ohio
      • Beavercreek, Ohio, Stati Uniti, 45431
        • Terminato
        • Research Site
      • Blue Ash, Ohio, Stati Uniti, 45242
        • Reclutamento
        • Research Site
      • Cleveland, Ohio, Stati Uniti, 44130
        • Terminato
        • Research Site
      • Columbus, Ohio, Stati Uniti, 43215
        • Reclutamento
        • Research Site
      • Columbus, Ohio, Stati Uniti, 43235
        • Terminato
        • Research Site
      • Marion, Ohio, Stati Uniti, 43302
        • Reclutamento
        • Research Site
      • Toledo, Ohio, Stati Uniti, 43617
        • Ritirato
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, Stati Uniti, 73071
        • Reclutamento
        • Research Site
      • Oklahoma City, Oklahoma, Stati Uniti, 73134
        • Reclutamento
        • Research Site
      • Tulsa, Oklahoma, Stati Uniti, 74133
        • Reclutamento
        • Research Site
    • Oregon
      • Grants Pass, Oregon, Stati Uniti, 97527
        • Terminato
        • Research Site
      • Medford, Oregon, Stati Uniti, 97504
        • Reclutamento
        • Research Site
      • Roseburg, Oregon, Stati Uniti, 97471
        • Ritirato
        • Research Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, Stati Uniti, 17011
        • Reclutamento
        • Research Site
      • DuBois, Pennsylvania, Stati Uniti, 15801
        • Ritirato
        • Research Site
      • Exton, Pennsylvania, Stati Uniti, 19341
        • Ritirato
        • Research Site
      • Philadelphia, Pennsylvania, Stati Uniti, 19140
        • Reclutamento
        • Research Site
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Reclutamento
        • Research Site
    • South Carolina
      • Anderson, South Carolina, Stati Uniti, 29621
        • Reclutamento
        • Research Site
      • Charleston, South Carolina, Stati Uniti, 29414
        • Reclutamento
        • Research Site
      • Charleston, South Carolina, Stati Uniti, 29414
        • Terminato
        • Research Site
      • Columbia, South Carolina, Stati Uniti, 29201
        • Ritirato
        • Research Site
      • Gaffney, South Carolina, Stati Uniti, 29340
        • Reclutamento
        • Research Site
      • Spartanburg, South Carolina, Stati Uniti, 29303
        • Reclutamento
        • Research Site
      • Union, South Carolina, Stati Uniti, 29379
        • Reclutamento
        • Research Site
    • South Dakota
      • Pierre, South Dakota, Stati Uniti, 57501
        • Ritirato
        • Research Site
      • Rapid City, South Dakota, Stati Uniti, 57701
        • Reclutamento
        • Research Site
      • Sioux Falls, South Dakota, Stati Uniti, 57104
        • Reclutamento
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, Stati Uniti, 37421
        • Reclutamento
        • Research Site
      • Elizabethton, Tennessee, Stati Uniti, 37643
        • Terminato
        • Research Site
      • Franklin, Tennessee, Stati Uniti, 37067
        • Reclutamento
        • Research Site
      • Morristown, Tennessee, Stati Uniti, 37813
        • Terminato
        • Research Site
      • Tullahoma, Tennessee, Stati Uniti, 37388
        • Reclutamento
        • Research Site
    • Texas
      • Abilene, Texas, Stati Uniti, 79606
        • Reclutamento
        • Research Site
      • Amarillo, Texas, Stati Uniti, 79106
        • Ritirato
        • Research Site
      • Austin, Texas, Stati Uniti, 78704
        • Terminato
        • Research Site
      • Brownsville, Texas, Stati Uniti, 78520
        • Reclutamento
        • Research Site
      • Dallas, Texas, Stati Uniti, 75254
        • Reclutamento
        • Research Site
      • Dallas, Texas, Stati Uniti, 75235
        • Terminato
        • Research Site
      • Dallas, Texas, Stati Uniti, 75225
        • Terminato
        • Research Site
      • El Paso, Texas, Stati Uniti, 79902
        • Reclutamento
        • Research Site
      • El Paso, Texas, Stati Uniti, 79902
        • Terminato
        • Research Site
      • Forney, Texas, Stati Uniti, 75126
        • Reclutamento
        • Research Site
      • Georgetown, Texas, Stati Uniti, 78633
        • Terminato
        • Research Site
      • Houston, Texas, Stati Uniti, 77074
        • Ritirato
        • Research Site
      • Houston, Texas, Stati Uniti, 77089
        • Reclutamento
        • Research Site
      • Houston, Texas, Stati Uniti, 77079
        • Reclutamento
        • Research Site
      • Houston, Texas, Stati Uniti, 77002
        • Reclutamento
        • Research Site
      • Houston, Texas, Stati Uniti, 77008
        • Terminato
        • Research Site
      • Houston, Texas, Stati Uniti, 77025
        • Terminato
        • Research Site
      • Houston, Texas, Stati Uniti, 77207
        • Terminato
        • Research Site
      • Houston, Texas, Stati Uniti, 77084
        • Terminato
        • Research Site
      • Houston, Texas, Stati Uniti, 77024
        • Terminato
        • Research Site
      • Katy, Texas, Stati Uniti, 77493
        • Ritirato
        • Research Site
      • Katy, Texas, Stati Uniti, 77450
        • Ritirato
        • Research Site
      • Kerrville, Texas, Stati Uniti, 78028
        • Terminato
        • Research Site
      • Kingwood, Texas, Stati Uniti, 77339
        • Reclutamento
        • Research Site
      • Lewisville, Texas, Stati Uniti, 75057
        • Sospeso
        • Research Site
      • McAllen, Texas, Stati Uniti, 78504
        • Reclutamento
        • Research Site
      • McKinney, Texas, Stati Uniti, 75069
        • Reclutamento
        • Research Site
      • Paris, Texas, Stati Uniti, 75462
        • Reclutamento
        • Research Site
      • Plano, Texas, Stati Uniti, 75093
        • Reclutamento
        • Research Site
      • Plano, Texas, Stati Uniti, 75024
        • Terminato
        • Research Site
      • Victoria, Texas, Stati Uniti, 77901
        • Terminato
        • Research Site
      • Waco, Texas, Stati Uniti, 76708
        • Reclutamento
        • Research Site
      • Wichita Falls, Texas, Stati Uniti, 76308
        • Terminato
        • Research Site
      • Wylie, Texas, Stati Uniti, 75098
        • Reclutamento
        • Research Site
    • Utah
      • Bountiful, Utah, Stati Uniti, 84010
        • Ritirato
        • Research Site
      • Ogden, Utah, Stati Uniti, 84405
        • Reclutamento
        • Research Site
      • Salt Lake City, Utah, Stati Uniti, 84107
        • Terminato
        • Research Site
      • West Jordan, Utah, Stati Uniti, 84088
        • Terminato
        • Research Site
      • West Valley City, Utah, Stati Uniti, 84120
        • Reclutamento
        • Research Site
    • Virginia
      • Newport News, Virginia, Stati Uniti, 23606
        • Terminato
        • Research Site
      • Norfolk, Virginia, Stati Uniti, 23504
        • Reclutamento
        • Research Site
      • Richmond, Virginia, Stati Uniti, 23219
        • Reclutamento
        • Research Site
      • Richmond, Virginia, Stati Uniti, 23226
        • Terminato
        • Research Site
      • Suffolk, Virginia, Stati Uniti, 23435
        • Reclutamento
        • Research Site
    • Washington
      • Spokane, Washington, Stati Uniti, 99218
        • Reclutamento
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, Stati Uniti, 26505
        • Terminato
        • Research Site
    • Wisconsin
      • Cudahy, Wisconsin, Stati Uniti, 53110
        • Reclutamento
        • Research Site
      • Milwaukee, Wisconsin, Stati Uniti, 53228
        • Reclutamento
        • Research Site
      • Milwaukee, Wisconsin, Stati Uniti, 53295
        • Terminato
        • Research Site
      • Gothenburg, Svezia, 41345
        • Reclutamento
        • Research Site
      • Gothenburg, Svezia, 413 46
        • Ritirato
        • Research Site
      • Höllviken, Svezia, 236 51
        • Reclutamento
        • Research Site
      • Kungsbacka, Svezia, 43480
        • Reclutamento
        • Research Site
      • Lund, Svezia, 22242
        • Reclutamento
        • Research Site
      • Stockholm, Svezia, 171 76
        • Reclutamento
        • Research Site
      • Stockholm, Svezia, 18288
        • Reclutamento
        • Research Site
      • Stockholm, Svezia, 117 27
        • Reclutamento
        • Research Site
      • Stockholm, Svezia, 11883
        • Reclutamento
        • Research Site
      • Umeå, Svezia, 901 85
        • Ritirato
        • Research Site
      • Uppsala, Svezia, 752 33
        • Reclutamento
        • Research Site
      • Örebro, Svezia, 70185
        • Reclutamento
        • Research Site
      • Bangkok, Tailandia, 10700
        • Reclutamento
        • Research Site
      • Hat Yai, Tailandia, 90110
        • Reclutamento
        • Research Site
      • Khlong Luang, Tailandia, 12120
        • Reclutamento
        • Research Site
      • Muang, Tailandia, 22000
        • Reclutamento
        • Research Site
      • Muang, Tailandia, 50200
        • Reclutamento
        • Research Site
      • Muang, Tailandia, 40002
        • Reclutamento
        • Research Site
      • Nonthaburi, Tailandia, 11000
        • Reclutamento
        • Research Site
      • Ongkharak, Tailandia, 26120
        • Reclutamento
        • Research Site
      • Phitsanulok, Tailandia, 65000
        • Reclutamento
        • Research Site
      • Ratchathewi, Tailandia, 10400
        • Reclutamento
        • Research Site
      • Changhua County, Taiwan, 500
        • Reclutamento
        • Research Site
      • Kaohsiung City, Taiwan, 82445
        • Reclutamento
        • Research Site
      • Kaohsiung City, Taiwan, TAIWAN
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 40705
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 404
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 40201
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 433004
        • Reclutamento
        • Research Site
      • Tainan, Taiwan, 70403
        • Reclutamento
        • Research Site
      • Taipei, Taiwan, 10002
        • Reclutamento
        • Research Site
      • Taipei, Taiwan, 10449
        • Terminato
        • Research Site
      • Taoyuan, Taiwan, 00333
        • Reclutamento
        • Research Site
      • Taoyuan City, Taiwan, 330
        • Reclutamento
        • Research Site
      • Yunlin, Taiwan, 640
        • Reclutamento
        • Research Site
      • Adana, Turchia (Türkiye), 01060
        • Reclutamento
        • Research Site
      • Adana, Turchia (Türkiye), 01330
        • Reclutamento
        • Research Site
      • Afyonkarahisar, Turchia (Türkiye), 03030
        • Reclutamento
        • Research Site
      • Antalya, Turchia (Türkiye), 07059
        • Reclutamento
        • Research Site
      • Bursa, Turchia (Türkiye), 16059
        • Reclutamento
        • Research Site
      • Bursa, Turchia (Türkiye), 16110
        • Reclutamento
        • Research Site
      • Isparta, Turchia (Türkiye), 32260
        • Ritirato
        • Research Site
      • Istanbul, Turchia (Türkiye), 34844
        • Reclutamento
        • Research Site
      • Istanbul, Turchia (Türkiye), 34785
        • Ritirato
        • Research Site
      • Izmir, Turchia (Türkiye), 35965
        • Reclutamento
        • Research Site
      • Izmir, Turchia (Türkiye), 35330
        • Reclutamento
        • Research Site
      • Kayseri, Turchia (Türkiye), 38030
        • Reclutamento
        • Research Site
      • Kocaeli, Turchia (Türkiye), 41380
        • Reclutamento
        • Research Site
      • Mersin, Turchia (Türkiye), 33343
        • Reclutamento
        • Research Site
      • Tekirdağ, Turchia (Türkiye), 59030
        • Reclutamento
        • Research Site
      • Zeytinburnu, Turchia (Türkiye), 34020
        • Reclutamento
        • Research Site
      • Çanakkale, Turchia (Türkiye), 17110
        • Reclutamento
        • Research Site
      • Çankaya, Turchia (Türkiye), 06700
        • Reclutamento
        • Research Site
      • Chernivtsi, Ucraina, 58029
        • Reclutamento
        • Research Site
      • Chernivtsі, Ucraina, 58002
        • Reclutamento
        • Research Site
      • Ivano-Frankivsk, Ucraina, 76018
        • Reclutamento
        • Research Site
      • Ivano-Frankivsk, Ucraina, 76019
        • Reclutamento
        • Research Site
      • Kyiv, Ucraina, 02081
        • Reclutamento
        • Research Site
      • Kyiv, Ucraina, 03037
        • Reclutamento
        • Research Site
      • Kyiv, Ucraina, 03680
        • Reclutamento
        • Research Site
      • Kyiv, Ucraina, 02002
        • Reclutamento
        • Research Site
      • Lviv, Ucraina, 79016
        • Reclutamento
        • Research Site
      • Ternopil, Ucraina, 46001
        • Reclutamento
        • Research Site
      • Uzhhorod, Ucraina, 88018
        • Reclutamento
        • Research Site
      • Uzhhorod, Ucraina, 88002
        • Reclutamento
        • Research Site
      • Vinnytsia, Ucraina, 21009
        • Ritirato
        • Research Site
      • Vinnytsia, Ucraina, 21001
        • Reclutamento
        • Research Site
      • Vinnytsia, Ucraina, 21029
        • Reclutamento
        • Research Site
      • Balatonfüred, Ungheria, 8230
        • Ritirato
        • Research Site
      • Budapest, Ungheria, 1121
        • Reclutamento
        • Research Site
      • Budapest, Ungheria, 1203
        • Ritirato
        • Research Site
      • Budapest, Ungheria, 1044
        • Reclutamento
        • Research Site
      • Békéscsaba, Ungheria, H-5600
        • Reclutamento
        • Research Site
      • Debrecen, Ungheria, 4032
        • Reclutamento
        • Research Site
      • Edelény, Ungheria, 3780
        • Reclutamento
        • Research Site
      • Encs, Ungheria, 3860
        • Ritirato
        • Research Site
      • Gyöngyös - Mátraháza, Ungheria, 3200
        • Completato
        • Research Site
      • Gödöllő, Ungheria, 2100
        • Ritirato
        • Research Site
      • Hajdúnánás, Ungheria, 4080
        • Reclutamento
        • Research Site
      • Kalocsa, Ungheria, 6300
        • Reclutamento
        • Research Site
      • Komádi, Ungheria, 4138
        • Reclutamento
        • Research Site
      • Monor, Ungheria, 2200
        • Ritirato
        • Research Site
      • Pécs, Ungheria, 7626
        • Ritirato
        • Research Site
      • Püspökladány, Ungheria, 4150
        • Reclutamento
        • Research Site
      • Szeged, Ungheria, 6724
        • Ritirato
        • Research Site
      • Szolnok, Ungheria, 5000
        • Reclutamento
        • Research Site
      • Százhalombatta, Ungheria, 2440
        • Reclutamento
        • Research Site
      • Székesfehérvár, Ungheria, 8000
        • Ritirato
        • Research Site
      • Tapolca, Ungheria, 8300
        • Reclutamento
        • Research Site
      • Törökbálint, Ungheria, 2045
        • Reclutamento
        • Research Site
      • Vajszló, Ungheria, 7838
        • Reclutamento
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing

    the ICF.

  2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)

  3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70%

    at V1.

  4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking;

    defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6

    months prior to V1.

  5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by

    the central laboratory

  6. A CAT score of ≥ 10 at Visit 1.

  7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b),

    (c), or (d)]:

    1. : Established CV Disease

    2. : Combination of CV risk factors:

      • Hypertension
      • Diabetes Mellitus
      • Chronic Kidney Disease
      • Dyslipidemia
      • Obesity
    3. : High risk of CV disease determined using an established CV risk assessment

      tool.

    4. : CT coronary Artery Calcification

  8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as

    required by the protocol.

  9. Willing to visit at the study site or participate in virtual visits as required per the protocol

    to complete all study assessments.

  10. A female is eligible to enter and participate in the study if the female is of:

    • Non-childbearing potential: either permanently sterilized or who are post-menopausal.
    • Childbearing potential: has a negative serum pregnancy test at V1 and must use one

    highly effective form of birth control.

  11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion Criteria:

  1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.

  2. End-stage renal disease requiring renal replacement therapy

  3. History of heart or lung transplant or actively listed for heart or lung transplant.

  4. Implanted left ventricular assist device or implant anticipated in < 3 months.

  5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.

  6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:

    1. An MI or unstable angina in the last 8 weeks
    2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.

    NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event.

  7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1

  8. Any life-threatening condition, including malignancy, with a life expectancy < 5 years, other than CV disease or COPD, that might prevent the participant from completing the study.

  9. Use of maintenance ICS treatment within the past 12 months.

  10. Unable to abstain from protocol-defined prohibited medications

  11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study).

  12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.

  13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

  14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

  15. Previous randomization in the present study.

  16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: BGF arm

BGF MDI 320/14.4/9.6 μg BID

Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

Sperimentale: GFF arm

GFF MDI 14.4/9.6 μg BID

Glycopyrronium and formoterol fumarate pressurized inhalation suspension

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first severe cardiac or COPD event
Lasso di tempo: Up to 3 years

Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.

Up to 3 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to first severe COPD exacerbation event
Lasso di tempo: Up to 3 years

Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe COPD exacerbations.

Up to 3 years
Time to first severe cardiac event
Lasso di tempo: Up to 3 years

Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe cardiac outcomes.

Up to 3 years
Time to cardiopulmonary death
Lasso di tempo: Up to 3 years

Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary deaths.

Up to 3 years
Moderate/severe COPD exacerbation rate
Lasso di tempo: Over time, up 3 years

Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on moderate/severe COPD exacerbations.

Over time, up 3 years
Time to Myocardial Infarction (MI) hospitalization or cardiac death
Lasso di tempo: Up to 3 years

Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to MI hospitalization (or cardiac death).

Up to 3 years
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
Lasso di tempo: Up to 3 years

Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to HF acute healthcare visit/hospitalization (or cardiac death).

Up to 3 years

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death
Lasso di tempo: Up to 3 years

To assess the safety and tolerability of BGF MDI and GFF MDI

Up to 3 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 febbraio 2024

Completamento primario (Stimato)

3 dicembre 2027

Completamento dello studio (Stimato)

3 dicembre 2027

Date di iscrizione allo studio

Primo inviato

21 febbraio 2024

Primo inviato che soddisfa i criteri di controllo qualità

21 febbraio 2024

Primo Inserito (Effettivo)

28 febbraio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 ottobre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • D5989C00001
  • 2023-507407-59-00 (Identificatore di registro: CTIS)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Periodo di condivisione IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criteri di accesso alla condivisione IPD

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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