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Studie for å vurdere PT010 hos voksne og ungdommer med utilstrekkelig kontrollert astma (LOGOS) (LOGOS)

8. juni 2026 oppdatert av: AstraZeneca

En randomisert, dobbeltblind, dobbel dummy, parallellgruppe, multisenterstudie med variabel lengde for å vurdere effektiviteten og sikkerheten til PT010 i forhold til PT009 og Symbicort® hos voksne og ungdommer med utilstrekkelig kontrollert astma

Dette er en studie med variabel lengde for å evaluere effektiviteten og sikkerheten til budesonid/glykopyrronium/formoterol-inhalatoren hos voksne og ungdom med alvorlig astma som er utilstrekkelig kontrollert med standardbehandling.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dette er en randomisert, dobbeltblind, dobbel dummy, parallellgruppe, multisenterstudie på 24 til 52 uker med variabel lengde for å vurdere effektiviteten og sikkerheten til budesonid, glykopyrronium og formoterolfumarat inhalator (MDI) i forhold til budesonid og formoterolfumarat MDI. og Symbicort® trykksatt MDI hos voksne og ungdommer med utilstrekkelig kontrollert astma. Omtrent 2200 deltakere vil bli randomisert globalt.

Studietype

Intervensjonell

Registrering (Faktiske)

2187

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Brasil
      • Botucatu, Brasil, 18618-970
        • Research Site
      • Porto Alegre, Brasil, 90610-000
        • Research Site
      • Porto Alegre, Brasil, 91350-200
        • Research Site
      • Porto Alegre, Brasil, 9002-060
        • Research Site
      • Porto Alegre, Brasil, 90430-001
        • Research Site
      • Santo André, Brasil, 09080-110
        • Research Site
      • Sorocaba, Brasil, 18040-425
        • Research Site
      • São Paulo, Brasil, 05403-000
        • Research Site
  • Colombia
      • Barranquilla, Colombia, 080020
        • Research Site
      • Bogotá, Colombia, 110221
        • Research Site
      • Cartagena, Colombia, 130013
        • Research Site
      • Medellín, Colombia, 050621
        • Research Site
      • Rionegro, Colombia, 054047
        • Research Site
  • Forente stater
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
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      • Tempe, Arizona, Forente stater, 85283
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      • Tucson, Arizona, Forente stater, 85741
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    • Arkansas
      • Hot Springs, Arkansas, Forente stater, 71913
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    • California
      • Bakersfield, California, Forente stater, 93301
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      • Carlsbad, California, Forente stater, 92008
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      • Huntington Beach, California, Forente stater, 92647
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      • Lancaster, California, Forente stater, 93534
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      • Long Beach, California, Forente stater, 90815
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      • Mission Viejo, California, Forente stater, 92691
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      • North Hollywood, California, Forente stater, 91606
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      • Northridge, California, Forente stater, 91324
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      • Rancho Cucamonga, California, Forente stater, 91730
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      • Sacramento, California, Forente stater, 95823
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      • San Diego, California, Forente stater, 92123
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      • San Jose, California, Forente stater, 95117
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      • Ventura, California, Forente stater, 93003
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      • Walnut Creek, California, Forente stater, 94598
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    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
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      • Colorado Springs, Colorado, Forente stater, 80910
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      • Wheat Ridge, Colorado, Forente stater, 80033
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    • Delaware
      • Newark, Delaware, Forente stater, 19713
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    • Florida
      • Boca Raton, Florida, Forente stater, 33487
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      • Clearwater, Florida, Forente stater, 33765
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      • Clearwater, Florida, Forente stater, 33756
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      • Cutler Bay, Florida, Forente stater, 33189
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      • DeBary, Florida, Forente stater, 32713
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      • Hialeah, Florida, Forente stater, 33016
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      • Lakeland, Florida, Forente stater, 33813
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      • Miami, Florida, Forente stater, 33135
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      • Tampa, Florida, Forente stater, 33615
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    • Georgia
      • Acworth, Georgia, Forente stater, 30101
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      • Atlanta, Georgia, Forente stater, 30322
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      • Atlanta, Georgia, Forente stater, 30350
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      • Snellville, Georgia, Forente stater, 30078
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    • Idaho
      • Boise, Idaho, Forente stater, 83706
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    • Illinois
      • Chicago, Illinois, Forente stater, 60621
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      • Normal, Illinois, Forente stater, 61761
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      • Peoria, Illinois, Forente stater, 61636
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    • Indiana
      • Evansville, Indiana, Forente stater, 47715
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    • Louisiana
      • Marrero, Louisiana, Forente stater, 70072
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      • Zachary, Louisiana, Forente stater, 70791
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    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
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      • White Marsh, Maryland, Forente stater, 21162
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    • Massachusetts
      • Fall River, Massachusetts, Forente stater, 02723
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    • Michigan
      • Farmington Hills, Michigan, Forente stater, 48336
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      • Rochester, Michigan, Forente stater, 48307
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      • Troy, Michigan, Forente stater, 48085
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    • Missouri
      • St Louis, Missouri, Forente stater, 63141
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    • Nevada
      • North Las Vegas, Nevada, Forente stater, 89030
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      • Portsmouth, New Hampshire, Forente stater, 03801
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      • Ocean City, New Jersey, Forente stater, 07712
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    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
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      • Brooklyn, New York, Forente stater, 11236
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      • The Bronx, New York, Forente stater, 10461
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      • The Bronx, New York, Forente stater, 10459
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      • The Bronx, New York, Forente stater, 10468
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    • North Carolina
      • Greensboro, North Carolina, Forente stater, 27405
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      • Huntersville, North Carolina, Forente stater, 28078
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      • Monroe, North Carolina, Forente stater, 28112
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    • Ohio
      • Columbus, Ohio, Forente stater, 43215
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    • Oregon
      • Portland, Oregon, Forente stater, 97202
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    • Pennsylvania
      • Jenkintown, Pennsylvania, Forente stater, 19046
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      • Philadelphia, Pennsylvania, Forente stater, 19107
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    • South Carolina
      • Spartanburg, South Carolina, Forente stater, 29303
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    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
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    • Texas
      • Amarillo, Texas, Forente stater, 79106
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      • Cedar Park, Texas, Forente stater, 78613
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      • Dallas, Texas, Forente stater, 75254
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      • Denison, Texas, Forente stater, 75020
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      • Forney, Texas, Forente stater, 75126
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      • Houston, Texas, Forente stater, 77074
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      • Houston, Texas, Forente stater, 77099
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      • Lewisville, Texas, Forente stater, 75067
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      • McKinney, Texas, Forente stater, 75069
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      • North Richland Hills, Texas, Forente stater, 76180
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      • Pearland, Texas, Forente stater, 77584
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      • Plano, Texas, Forente stater, 75093
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      • San Antonio, Texas, Forente stater, 78258
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      • Sugar Land, Texas, Forente stater, 77478
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      • Victoria, Texas, Forente stater, 77901
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    • Utah
      • Roy, Utah, Forente stater, 84067
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    • Virginia
      • Abingdon, Virginia, Forente stater, 24210
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      • Burke, Virginia, Forente stater, 22015
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      • Williamsburg, Virginia, Forente stater, 23188
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    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
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      • Milwaukee, Wisconsin, Forente stater, 53228
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  • Hellas
      • Alexandroupoli, Hellas, 68100
        • Research Site
      • Athens, Hellas, 11527
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      • Athens, Hellas, 12462
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      • Athens, Hellas, 11521
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      • Athens, Hellas, 17562
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      • Corfu, Hellas, 49100
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      • Exohi Thessaloniki, Hellas, 57010
        • Research Site
      • Ioannina, Hellas, 45500
        • Research Site
      • Pátrai, Hellas, 26500
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      • Thessaloniki, Hellas, 57010
        • Research Site
      • Thessaloniki, Hellas, 56429
        • Research Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Research Site
      • Beersheba, Israel, 84101
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      • Haifa, Israel, 34362
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      • Haifa, Israel, 31096
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      • Holon, Israel, 5837738
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      • Jerusalem, Israel, 9112001
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      • Jerusalem, Israel, 9103102
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      • Kfar Saba, Israel, 4428164
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      • Petah Tikva, Israel, 4920235
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      • Rehovot, Israel, 76100
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      • Tel Aviv, Israel, 6423906
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  • Kina
      • Baotou, Kina, 014010
        • Research Site
      • Beijing, Kina, 100020
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      • Changsha, Kina, 410008
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      • Changsha, Kina, 430033
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      • Changsha, Kina, 410005
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      • Changzhi, Kina, 46000
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      • Chengdu, Kina, 611130
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      • Chengdu, Kina, 610072
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      • Chizhou, Kina, 247099
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      • Chongqing, Kina, 400038
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      • Chongqing, Kina, 400010
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      • Dongguan, Kina, 523413
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      • Dongyang, Kina, 322100
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      • Fuzhou, Kina, 350025
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      • Guangzhou, Kina, 510120
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      • Guangzhou, Kina, 510180
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      • Guangzhou, Kina, 510100
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      • Guangzhou, Kina, 510630
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      • Guangzhou, Kina, 510062
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      • Guangzhou, Kina, 510280
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      • Haikou, Kina, 570311
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      • Haikou, Kina, 570208
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      • Hangzhou, Kina, 310005
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      • Hangzhou, Kina, 310009
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      • Hefei, Kina, 230000
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      • Hefei, Kina, 230011
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      • Hefei, Kina, 230061
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      • Huai'an, Kina, 223300
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      • Huizhou, Kina, 516001
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      • Jinan, Kina, 250014
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      • Jinhua, Kina, 321000
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      • Kunming, Kina, 650032
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      • Kunming, Kina, 650051
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      • Lanzhou, Kina, 730000
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      • Liuzhou, Kina, 545006
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      • Luoyang, Kina, 471003
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      • Nanchang, Kina, 330006
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      • Nanchong, Kina, 637000
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      • Nanjing, Kina, 210009
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      • Nanjing, Kina, 210029
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      • Nanjing, Kina, 210006
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      • Nanjing, Kina, 210008
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      • Nanning, Kina, 530021
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      • Qingdao, Kina, 266000
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      • Qingdao, Kina, 266042
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      • Shanghai, Kina, 200032
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      • Shanghai, Kina, 200080
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      • Shanghai, Kina, 200025
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      • Shanghai, Kina, 201199
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      • Shanghai, Kina, 200065
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      • Shanghai, Kina, 200092
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      • Shanghai, Kina, 200240
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      • Shaoxing, Kina, 312000
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      • Shengyang, Kina, 110004
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      • Shenyang, Kina, 110001
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      • Shenyang, Kina, 110015
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      • Shenyang, Kina, 110075
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      • Shenzhen, Kina, 518039
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      • Shenzhen, Kina, 518036
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      • Shenzhen, Kina, 518020
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      • Shijiazhuang, Kina, 50051
        • Research Site
      • Taiyuan, Kina, 030001
        • Research Site
      • Taiyuan, Kina, 030032
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      • Taizhou, Kina, 318020
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      • Weifang, Kina, 261000
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      • Wuhan, Kina, 430030
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      • Wuhan, Kina, 430010
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      • Wuhu, Kina, 241000
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      • Xi'an, Kina, 710004
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      • Xi'an, Kina, 710077
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      • Xinxiang, Kina, 453002
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      • Xuzhou, Kina, 221009
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      • Xuzhou, Kina, 221000
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      • Yangzhou, Kina, 225001
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      • Yantai, Kina, 264000
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      • Yinchuan, Kina, 750001
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      • Yinchuan, Kina, 750004
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      • Yueyang, Kina, 414000
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      • Zhangzhou, Kina, 363099
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      • Zhanjiang, Kina, 524001
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      • Zhengzhou, Kina, 450000
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      • Zhuji, Kina, 311899
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      • Ürümqi, Kina, 830054
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  • Mexico
      • Cuernavaca, Mexico, 62290
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      • Durango, Mexico, 43080
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      • Guadalajara, Mexico, 44200
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      • Mazatlán, Mexico, 82000
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      • Monterrey, Mexico, 64710
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      • Monterrey, Mexico, 64620
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      • Monterrey, Mexico, 64718
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      • Mérida, Mexico, 97070
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      • Veracruz, Mexico, 91910
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      • Villahermosa, Mexico, 86035
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      • Zapopan, Mexico, 45138
        • Research Site
  • Portugal
      • Amadora, Portugal, 2720-276
        • Research Site
      • Braga, Portugal, 4710
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      • Coimbra, Portugal, 3040-316
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      • Figueira da Foz Municipality, Portugal, 3094-001
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      • Guimarães, Portugal, 4835-044
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      • Lisbon, Portugal, 1649-035
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      • Lisbon, Portugal, 1998-018
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      • Matosinhos Municipality, Portugal, 4454-509
        • Research Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
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      • Ponce, Puerto Rico, 00780
        • Research Site
  • Russland
      • Chelyabinsk, Russland, 454106
        • Research Site
      • Izhevsk, Russland, 426035
        • Research Site
      • Kazan', Russland, 420008
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      • Kemerovo, Russland, 650002
        • Research Site
      • Moscow, Russland, 125284
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      • Moscow, Russland, 115522
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      • Omsk, Russland, 644050
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      • Penza, Russland, 440067
        • Research Site
      • Perm, Russland, 614000
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      • Saint Petersburg, Russland, 194354
        • Research Site
      • Saint Petersburg, Russland, 195257
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      • Saratov, Russland, 410028
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      • Saratov, Russland, 410053
        • Research Site
      • Tomsk, Russland, 634050
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      • Ulyanovsk, Russland, 432009
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  • Slovakia
      • Bojnice, Slovakia, 972 01
        • Research Site
      • Kežmarok, Slovakia, 060 01
        • Research Site
      • Košice, Slovakia, 04022
        • Research Site
      • Levice, Slovakia, 934 01
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      • Levice, Slovakia, 93401
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      • Nové Zámky, Slovakia, 94001
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      • Poprad, Slovakia, 058 01
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      • Prešov, Slovakia, 081 81
        • Research Site
      • Ružomberok, Slovakia, 034 26
        • Research Site
      • Topoľčany, Slovakia, 95501
        • Research Site
      • Šurany, Slovakia, 94201
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      • Žilina, Slovakia, 010 01
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  • Storbritannia
      • Blackpool, Storbritannia, FY3 7EN
        • Research Site
      • Bradford, Storbritannia, BD9 6RJ
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      • Corby, Storbritannia, NN17 2UR
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      • Hull, Storbritannia, HU16 5JQ
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      • Leicester, Storbritannia, LE5 4LJ
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      • Rhyl, Storbritannia, LL18 1DA
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  • Sør-Afrika
      • Bloemfontein, Sør-Afrika, 9301
        • Research Site
      • Cape Town, Sør-Afrika, 7700
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      • Cape Town, Sør-Afrika, 7764
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      • Durban, Sør-Afrika, 4001
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      • Durban, Sør-Afrika, 4091
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      • Durban, Sør-Afrika, 4450
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      • Durban, Sør-Afrika, 4093
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      • Johannesburg, Sør-Afrika, 2001
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      • Lenasia, Sør-Afrika, 1821
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      • Lenasia Ext8, Sør-Afrika, 1820
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      • Panorama, Sør-Afrika, 7500
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      • Pretoria, Sør-Afrika, 0186
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      • Tygervalley, Sør-Afrika, 7530
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      • eMkhomazi, Sør-Afrika, 4170
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  • Tsjekkia
      • Brandýs nad Labem, Tsjekkia, 250 01
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      • Jindřichův Hradec, Tsjekkia, 377 01
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      • Lovosice, Tsjekkia, 410 02
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      • Mladá Boleslav, Tsjekkia, 293 01
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      • Nový Bor, Tsjekkia, 473 01
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      • Prague, Tsjekkia, 190 00
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      • Prague, Tsjekkia, 148 00
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      • Rokycany, Tsjekkia, 337 22
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      • Strakonice, Tsjekkia, 38601
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      • Teplice, Tsjekkia, 415 01
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      • Varnsdorf, Tsjekkia, 407 47
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  • Tyrkia (Türkiye)
      • Adana, Tyrkia (Türkiye), 1260
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      • Ankara, Tyrkia (Türkiye), 06
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      • Istanbul, Tyrkia (Türkiye), 34098
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      • Istanbul, Tyrkia (Türkiye), 34844
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      • Izmir, Tyrkia (Türkiye), 35110
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      • Mersin, Tyrkia (Türkiye), 33343
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      • Pamukkale, Tyrkia (Türkiye), 20070
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  • Tyskland
      • Bamberg, Tyskland, 96049
        • Research Site
      • Berlin, Tyskland, 10367
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      • Berlin, Tyskland, 10717
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      • Berlin, Tyskland, 10119
        • Research Site
      • Berlin, Tyskland, 10787
        • Research Site
      • Berlin, Tyskland, 12203
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      • Berlin, Tyskland, 13187
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      • Berlin, Tyskland, 12159
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      • Darmstadt, Tyskland, 64283
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      • Frankfurt, Tyskland, 60596
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      • Frankfurt am Main, Tyskland, 60596
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      • Frankfurt am Main, Tyskland, 60389
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      • Fürstenwalde, Tyskland, 15517
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      • Geesthacht, Tyskland, 21502
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      • Hanover, Tyskland, 30449
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      • Hanover, Tyskland, D-30173
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      • Heidelberg, Tyskland, 69115
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      • Koblenz, Tyskland, 56068
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      • Landsberg, Tyskland, 86899
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      • Leipzig, Tyskland, 04103
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      • Leipzig, Tyskland, 04207
        • Research Site
      • Leipzig, Tyskland, 04299
        • Research Site
      • Mainz, Tyskland, 55128
        • Research Site
      • München-Pasing, Tyskland, 81241
        • Research Site
      • Witten, Tyskland, 58452
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 80 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  1. 12 til 80 år, mann og kvinne, BMI
  2. Dokumentert historie med legediagnostisert astma > og/eller = 1 år før V1.
  3. Regelmessig bruk av et stabilt daglig ICS/LABA-regime (inkludert en stabil ICS-dose) med middels til høye ICS-doser i minst 4 uker før V1.
  4. ACQ-7 totalscore ≥1,5 ved besøk 1, 3 og 5 (pre-randomisering).

  5. FEV1 % (vurdert som et gjennomsnitt av 60 og 30 minutters førdosevurderinger) spådd normal ved V1, 2, 3, 4 og 5 (pre-randomisering)

    • Deltakere > og/eller = 18 år: < 80 %
    • Deltakere 12 til

  6. FEV1 post-albuterol ved V2 eller V3 (hvis gjentakelse er nødvendig). • Deltakere > og/eller = 18 år: Økning > og/eller = 12 % og > og/eller = 200 ml.

    • Deltakere 12 til
    • Merk: Reversibilitetstesting er fortsatt nødvendig ved besøk 2 og/eller besøk 3, selv om pasienten har dokumentert historisk reversibilitet rapportert i de 12 månedene før besøk 1.
  7. Villig og, etter etterforskerens oppfatning, i stand til å justere gjeldende astmabehandling, som kreves av protokollen.
  8. Demonstrere akseptabel MDI/pMDI-administrasjonsteknikk.
  9. Fikk ingen astmamedisiner annet enn innkjørt BFF MDI BID og albuterol etter behov under screening (bortsett fra tillatte medisiner som definert i tabell 9 og systemisk kortikosteroid eller ICS for behandling av en astmaforverring).
  10. eDiary 14-dagers samsvar ≥70 % under screening (definert som å fylle ut den daglige e-dagboken for alle 10 morgener og alle 10 kvelder og svare "Ja" til å ta 2 drag med innkjørt BFF MDI for alle 10 morgener og 10 kvelder de siste 14 dager før randomisering).
  11. Ingen luftveisinfeksjon i de 4 ukene før randomisering, eller astmaforverring behandlet med systemisk kortikosteroid og/eller ytterligere ICS-behandling i de 4 ukene før randomisering.

Ekskluderingskriterier:

1. Fullført behandling for luftveisinfeksjon eller astmaforverring med systemiske kortikosteroider innen 4 uker etter V1.

2a. Deltakere hvor det etter utrederens vurdering vil være hensiktsmessig med biologisk behandling for astma.

2b. Eventuelle markedsførte eller biologiske undersøkelser innen 3 måneder eller 5 halveringstider av V1, avhengig av hva som er lengst og må ikke brukes under studiens varighet.

3. Nåværende røykere, tidligere røykere med >10 års historie, eller tidligere røykere som sluttet å røyke

4. Nåværende bevis på KOLS.

5a. Oral og IV kortikosteroidbruk (en hvilken som helst dose) innen 4 uker etter V1.

5b. Bruk av systemiske kortikosteroider av andre grunner bortsett fra akuttbehandling av alvorlig astmaforverring er forbudt så lenge studien varer.

5c. Depotkortikosteroidbruk uansett årsak innen 12 måneder etter V1.

6. Bruk av LAMA, enten alene eller som del av en inhalasjonskombinasjonsbehandling, i løpet av de 12 ukene før besøk 1.

7. Bruk av oral b2-agonist innen 3 måneder etter V1.

8. Bruk av immunmodulatorer eller immundempende medisiner innen 3 måneder eller 5 halveringstider, avhengig av hva som er lengst, og må ikke brukes i løpet av studiens varighet.

9. Trangvinklet glaukom ikke tilstrekkelig behandlet og/eller endring i synet som kan være relevant, etter etterforskerens oppfatning, innen 3 måneder etter besøk 1.

10. Livstruende astma definert som en historie med betydelig(e) astmaepisoder som krever intubasjon assosiert med hyperkapni, respirasjonsstans, hypoksiske anfall eller astma-relaterte synkopale episode(r).

11. Sykehusinnleggelse for astma innen 2 måneder etter besøk 1.

12. Kjent historie med narkotika- eller alkoholmisbruk innen 12 måneder etter besøk 1.

13. Regelmessig bruk av en forstøver eller en hjemmeforstøver for mottak av astmamedisiner.

14. Bruk av urteprodukter ved inhalasjon eller forstøver innen 4 uker etter besøk 1 og godtar ikke å stoppe under studiens varighet.

15. Deltakelse i en annen klinisk studie med et undersøkelsesprodukt.

16. Deltakere med kjent overfølsomhet overfor beta2-agonister, kortikosteroider, antikolinergika eller en hvilken som helst komponent i MDI eller pMDI.

17. Studieetterforskere, underetterforskere, koordinatorer og deres ansatte eller nærmeste familiemedlemmer.

18. Kun for kvinner - for øyeblikket gravide (bekreftet med positiv svært sensitiv graviditetstest), amming, eller planlagt graviditet under studien eller ikke bruker akseptable prevensjonstiltak, som bedømt av etterforskeren.

Vennligst se studieprotokollen for den fullstendige listen over inklusjons- og eksklusjonskriterier

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Budesonid, glykopyrronium og formoterolfumarat (BGF) MDI 320/28,8/9,6 μg
BGF MDI 320/28,8/9,6 μg Budesonid, glykopyrronium og formoterolfumarat (PT010) Måledoseinhalator (MDI)
Legemiddel: BGF MDI 320/28,8/9,6 μg
Budesonid-, glykopyrronium- og formoterolfumarat-doseinhalator
Andre navn:
  • BGF
Eksperimentell: BGF MDI 320/14,4/9,6 μg
BGF MDI 320/14,4/9,6 μg Budesonid, glykopyrronium og formoterolfumarat (PT010) Måledoseinhalator (MDI)
Legemiddel: BGF MDI 320/14,4/9,6 μg
Budesonid-, glykopyrronium- og formoterolfumarat-doseinhalator
Andre navn:
  • BGF
Aktiv komparator: Budesonid og formoterolfumarat (BFF) MDI 320/9,6 μg
BFF MDI 320/9,6 μg (eksperimentell/sammenligningsmiddel) Budesonid og formoterolfumarat (PT009) Inhalator med oppmålt dose (MDI)
Legemiddel: BFF MDI 320/9,6 μg
Budesonid og formoterolfumarat doseinhalator
Andre navn:
  • BFF
Aktiv komparator: Symbicort®
Budesonid/formoterolfumarat trykksatt doseinhalator (pMDI) 320/9 μg
Legemiddel: BFF pMDI 320/9 μg
Budesonid/formoterolfumarat trykksatt doseinhalator
Andre navn:
  • Symbicort®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in FEV1 AUC0-3 (L) at Week 24
Tidsramme: Week 24
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations
Tidsramme: Up to 52 Weeks
Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24
Tidsramme: Week 24
Change from baseline in morning pre-dose trough FEV1 at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1
Tidsramme: Day 1
Onset of action on Day 1: Absolute change in FEV1 (L) at 5 minutes on Day 1. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Day 1
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]) +12 (≥0.5 increase equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline
Tidsramme: Up to 52 Weeks
Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤55% at baseline was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1
Tidsramme: Up to 52 Weeks
Rate of severe asthma exacerbations for participants with ≥1 severe exacerbation in the 12 months prior to Visit 1 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks
Pooled (LOGOS/KALOS): Time to First Severe Asthma Exacerbation
Tidsramme: Up to 52 weeks
Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 weeks
Pooled (LOGOS/KALOS): Rate of Moderate or Severe Asthma Exacerbations
Tidsramme: Up to 52 Weeks
Rate of moderate/severe exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate exacerbation was a worsening of symptoms that resulted in additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 Weeks
Pooled (LOGOS/KALOS): Time to First Moderate or Severe Asthma Exacerbation
Tidsramme: Up to 52 weeks
Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first moderate or severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first moderate/severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Up to 52 weeks
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24
Pooled (LOGOS/KALOS): Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24
Tidsramme: Week 24
Percentage of responders in AQLQ(s) +12 (≥0.5 increase equals response) at Week 24 was assessed in a pre- specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Week 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Etterforskere

  • Hovedetterforsker: Robert Wise, MD, Johns Hopkins University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2021

Primær fullføring (Faktiske)

20. mars 2025

Studiet fullført (Faktiske)

20. mars 2025

Datoer for studieregistrering

Først innsendt

26. oktober 2020

Først innsendt som oppfylte QC-kriteriene

26. oktober 2020

Først lagt ut (Faktiske)

30. oktober 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D5982C00008
  • 2020-001521-31 (EudraCT-nummer)
  • 2023-505786-88 (Registeridentifikator: CTIS)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalifiserte forskere kan be om tilgang til anonymiserte individuelle data på pasientnivå fra AstraZeneca gruppe av selskaper sponset kliniske studier via forespørselsportalen. Alle forespørsler vil bli evaluert i henhold til AZ-avsløringsforpliktelsen: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD-delingstidsramme

AstraZeneca vil oppfylle eller overgå datatilgjengelighet i henhold til forpliktelsene som er gitt til EFPIA Pharmas datadelingsprinsipper. For detaljer om tidslinjene våre, vennligst referer til vår avsløringsforpliktelse på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Tilgangskriterier for IPD-deling

Når en forespørsel er godkjent, vil AstraZeneca gi tilgang til de avidentifiserte individuelle dataene på pasientnivå i et godkjent sponset verktøy. Signert datadelingsavtale (ikke-omsettelig kontrakt for dataaksessors) må være på plass før du får tilgang til forespurt informasjon. I tillegg må alle brukere godta vilkårene og betingelsene til SAS MSE for å få tilgang. For ytterligere detaljer, vennligst se avsløringserklæringene på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere