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

23. 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 inhalator hos voksne og ungdom med alvorlig astma som er utilstrekkelig kontrollert med standard behandling.

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)

2274

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1121ABE
        • Research Site
      • CABA, Argentina, C1425BEN
        • Research Site
      • CABA, Argentina, 1056
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1425
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1280AEB
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1414AIF
        • Research Site
      • Córdoba, Argentina, X5003DCE
        • Research Site
      • Florida, Argentina, B1602DQD
        • Research Site
      • Mar del Plata, Argentina, 7600
        • Research Site
      • Mendoza, Argentina, M5500CCG
        • Research Site
      • Ranelagh, Argentina, 1886
        • Research Site
      • Rosario, Argentina, 2000
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Research Site
      • San Fernando, Argentina, B1646EBJ
        • Research Site
  • Belgia
      • Liège, Belgia, 4000
        • Research Site
      • Namur, Belgia, 5101
        • Research Site
  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Research Site
      • Dupnitsa, Bulgaria, 2602
        • Research Site
      • Haskovo, Bulgaria, 6305
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      • Kozloduy, Bulgaria, 3320
        • Research Site
      • Lovech, Bulgaria, 5500
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      • Pazardzhik, Bulgaria, 4400
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      • Petrich, Bulgaria, 2850
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      • Pleven, Bulgaria, 5800
        • Research Site
      • Rousse, Bulgaria, 7002
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      • Rousse, Bulgaria, 7000
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      • Sevlievo, Bulgaria, 5403
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      • Sliven, Bulgaria, 8800
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      • Smolyan, Bulgaria, 3700
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      • Sofia, Bulgaria, 1000
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      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1606
        • Research Site
      • Sofia, Bulgaria, 1421
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      • Stara Zagora, Bulgaria, 6003
        • Research Site
      • Stara Zagora, Bulgaria, 6000
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      • Varna, Bulgaria, 9000
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      • Veliko Tarnovo, Bulgaria, 5000
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      • Vidin, Bulgaria, 3700
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      • Vratsa, Bulgaria, 3000
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  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
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      • Sherwood Park, Alberta, Canada, T8H 2M7
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    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 4N7
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      • Vancouver, British Columbia, Canada, V5Z 1M9
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      • Vancouver, British Columbia, Canada, V6Z 1Y6
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    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
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      • Winnipeg, Manitoba, Canada, R3L 1Z5
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    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
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      • Burlington, Ontario, Canada, L7N 3V2
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      • Hamilton, Ontario, Canada, L8S 1G5
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      • London, Ontario, Canada, N6A 1V2
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      • Newmarket, Ontario, Canada, L3Y 5G8
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      • Niagara Falls, Ontario, Canada, L2H 1H5
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      • Toronto, Ontario, Canada, M9V 4B4
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      • Toronto, Ontario, Canada, M5G 1E2
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    • Quebec
      • Québec, Quebec, Canada, G1G 3Y8
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      • Québec, Quebec, Canada, G2J 0C4
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      • Québec, Quebec, Canada, G1V 4W2
        • Research Site
  • Chile
      • Chile, Chile, 7770484
        • Research Site
      • Curicó, Chile, 3341643
        • Research Site
      • Quillota, Chile, 2260000
        • Research Site
      • Santiago, Chile, 7500698
        • Research Site
      • Santiago, Chile, 8207257
        • Research Site
      • Santiago, Chile, 7500571
        • Research Site
      • Talca, Chile, 3481349
        • Research Site
  • Filippinene
      • Baguio City, Filippinene, 2600
        • Research Site
      • Davao City, Filippinene, PH-8000
        • Research Site
      • Iloilo City, Filippinene, 5000
        • Research Site
      • Las Piñas, Filippinene, 1742
        • Research Site
      • Lipa City, Filippinene, 4217
        • Research Site
      • Los Baños, Filippinene, 4030
        • Research Site
      • Manila, Filippinene, 1000
        • Research Site
      • Manila, Filippinene, 1014
        • Research Site
      • Marilao, Filippinene, 3019
        • Research Site
      • Quezon City, Filippinene
        • Research Site
      • Quezon City, Filippinene, 1101
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  • Forente stater
    • Alabama
      • Saraland, Alabama, Forente stater, 36571
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    • Arizona
      • Phoenix, Arizona, Forente stater, 85018
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      • Phoenix, Arizona, Forente stater, 85027
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      • Sun City West, Arizona, Forente stater, 85375
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      • Tucson, Arizona, Forente stater, 85715
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      • Tucson, Arizona, Forente stater, 85745
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    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72209
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    • California
      • Covina, California, Forente stater, 91723
        • Research Site
      • Encinitas, California, Forente stater, 92024
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      • Fresno, California, Forente stater, 93701
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      • Laguna Hills, California, Forente stater, 92653
        • Research Site
      • Long Beach, California, Forente stater, 90806
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      • Los Angeles, California, Forente stater, 90027
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      • Los Angeles, California, Forente stater, 90017
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      • Mission Hills, California, Forente stater, 91345
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      • Newport Beach, California, Forente stater, 92663
        • Research Site
      • Northridge, California, Forente stater, 91324
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      • San Diego, California, Forente stater, 92119
        • Research Site
      • Stockton, California, Forente stater, 95207
        • Research Site
      • Thousand Oaks, California, Forente stater, 91360
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      • Upland, California, Forente stater, 91786
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      • Westminster, California, Forente stater, 92683
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    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80923
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      • Lakewood, Colorado, Forente stater, 80228
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    • Florida
      • Brandon, Florida, Forente stater, 33511
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      • Miami, Florida, Forente stater, 33175
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      • Tampa, Florida, Forente stater, 33607
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    • Georgia
      • Adairsville, Georgia, Forente stater, 30103
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      • Atlanta, Georgia, Forente stater, 30344
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      • Columbus, Georgia, Forente stater, 31904
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      • Lawrenceville, Georgia, Forente stater, 30046
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      • Rincon, Georgia, Forente stater, 31326
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      • Savannah, Georgia, Forente stater, 31406
        • Research Site
      • Tyrone, Georgia, Forente stater, 30290
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    • Illinois
      • Chicago, Illinois, Forente stater, 60657
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      • River Forest, Illinois, Forente stater, 60305
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    • Indiana
      • Brownsburg, Indiana, Forente stater, 46112
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      • Indianapolis, Indiana, Forente stater, 46202
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40217
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    • Louisiana
      • Crowley, Louisiana, Forente stater, 70526
        • Research Site
      • Lafayette, Louisiana, Forente stater, 70508
        • Research Site
      • Lake Charles, Louisiana, Forente stater, 70601
        • Research Site
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • Research Site
    • Maryland
      • Potomac, Maryland, Forente stater, 20854
        • Research Site
      • Waldorf, Maryland, Forente stater, 20601
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Research Site
    • Missouri
      • Hannibal, Missouri, Forente stater, 63401
        • Research Site
      • St Louis, Missouri, Forente stater, 63141
        • Research Site
    • Montana
      • Missoula, Montana, Forente stater, 59808
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, Forente stater, 68123
        • Research Site
      • Lincoln, Nebraska, Forente stater, 68510
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Research Site
    • New Jersey
      • Toms River, New Jersey, Forente stater, 08755
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87108
        • Research Site
    • New York
      • New Hyde Park, New York, Forente stater, 11042
        • Research Site
      • New Windsor, New York, Forente stater, 12553
        • Research Site
      • New York, New York, Forente stater, 10016
        • Research Site
      • The Bronx, New York, Forente stater, 10455
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28277
        • Research Site
      • Denver, North Carolina, Forente stater, 28037
        • Research Site
      • Gastonia, North Carolina, Forente stater, 28054
        • Research Site
      • Raleigh, North Carolina, Forente stater, 27607
        • Research Site
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58104
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45231
        • Research Site
      • Cincinnati, Ohio, Forente stater, 45229
        • Research Site
      • Maumee, Ohio, Forente stater, 43537
        • Research Site
      • Toledo, Ohio, Forente stater, 43617
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, Forente stater, 73034
        • Research Site
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Research Site
      • Tulsa, Oklahoma, Forente stater, 74133
        • Research Site
    • Oregon
      • Grants Pass, Oregon, Forente stater, 97527
        • Research Site
    • Pennsylvania
      • DuBois, Pennsylvania, Forente stater, 15801
        • Research Site
      • Pittsburgh, Pennsylvania, Forente stater, 15241
        • Research Site
      • Pittsburgh, Pennsylvania, Forente stater, 15236
        • Research Site
      • Scottdale, Pennsylvania, Forente stater, 15683
        • Research Site
      • Smithfield, Pennsylvania, Forente stater, 15478
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, Forente stater, 02914
        • Research Site
    • South Carolina
      • Anderson, South Carolina, Forente stater, 29621
        • Research Site
      • Greenville, South Carolina, Forente stater, 29607
        • Research Site
      • North Charleston, South Carolina, Forente stater, 29406
        • Research Site
    • Tennessee
      • Franklin, Tennessee, Forente stater, 37067
        • Research Site
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Research Site
      • Austin, Texas, Forente stater, 78759
        • Research Site
      • Boerne, Texas, Forente stater, 78006
        • Research Site
      • Cypress, Texas, Forente stater, 77429
        • Research Site
      • Dallas, Texas, Forente stater, 75231
        • Research Site
      • El Paso, Texas, Forente stater, 79912
        • Research Site
      • Harlingen, Texas, Forente stater, 78550
        • Research Site
      • Houston, Texas, Forente stater, 77030
        • Research Site
      • Houston, Texas, Forente stater, 77021
        • Research Site
      • Kerrville, Texas, Forente stater, 78028
        • Research Site
      • Lampasas, Texas, Forente stater, 76550
        • Research Site
      • Nederland, Texas, Forente stater, 77627
        • Research Site
      • Pearland, Texas, Forente stater, 77584
        • Research Site
      • Red Oak, Texas, Forente stater, 75154
        • Research Site
      • San Antonio, Texas, Forente stater, 78229
        • Research Site
      • San Antonio, Texas, Forente stater, 78215
        • Research Site
      • San Antonio, Texas, Forente stater, 78258
        • Research Site
      • Spring, Texas, Forente stater, 77386
        • Research Site
      • Tomball, Texas, Forente stater, 77375
        • Research Site
    • Utah
      • Ogden, Utah, Forente stater, 84404
        • Research Site
      • West Valley City, Utah, Forente stater, 84120
        • Research Site
    • Vermont
      • Colchester, Vermont, Forente stater, 05446
        • Research Site
    • Virginia
      • Manassas, Virginia, Forente stater, 20110
        • Research Site
    • West Virginia
      • Kingwood, West Virginia, Forente stater, 26537
        • Research Site
      • Morgantown, West Virginia, Forente stater, 26505
        • Research Site
    • Wisconsin
      • Cudahy, Wisconsin, Forente stater, 53110
        • Research Site
  • India
      • Ahmedabad, India, 382415
        • Research Site
      • Aligarh, India, 202002
        • Research Site
      • Belagavi, India, 590010
        • Research Site
      • Coimbatore, India, 641028
        • Research Site
      • Dehradun, India, 248001
        • Research Site
      • Gurgaon, India, 122001
        • Research Site
      • Jaipur, India, 302039
        • Research Site
      • Mohali, India, 160062
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      • Nagpur, India, 440012
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      • New Delhi, India, 110060
        • Research Site
      • New Delhi, India, 110075
        • Research Site
      • New Delhi, India, 110029
        • Research Site
      • Thane, India, 401107
        • Research Site
      • Visakhapatnam, India, 530002
        • Research Site
  • Italia
      • Bari, Italia, 70124
        • Research Site
      • Casatenovo, Italia, 23880
        • Research Site
      • Cona, Italia, 44124
        • Research Site
      • Monserrato, Italia, 09042
        • Research Site
      • Naples, Italia, 80131
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      • Pisa, Italia, 56100
        • Research Site
      • Roma, Italia, 00168
        • Research Site
      • Roma, Italia, 00133
        • Research Site
  • Japan
      • Chino-shi, Japan, 391-0011
        • Research Site
      • Chūōku, Japan, 103-0027
        • Research Site
      • Chūōku, Japan, 104-0031
        • Research Site
      • Chūōku, Japan, 103-0022
        • Research Site
      • Fukui-shi, Japan, 910-8526
        • Research Site
      • Fukuoka, Japan, 819-8555
        • Research Site
      • Fukuoka, Japan, 811-1394
        • Research Site
      • Habikino-shi, Japan, 583-8588
        • Research Site
      • Hamamatsu, Japan, 431-3192
        • Research Site
      • Higashiibaraki-gun, Japan, 311-3117
        • Research Site
      • Himeji-shi, Japan, 672-8064
        • Research Site
      • Hiroshima-shi, Naka-ku, Japan, 730-0853
        • Research Site
      • Hitachi-Naka, Japan, 312-0057
        • Research Site
      • Ikoma-shi, Japan, 630-0293
        • Research Site
      • Kishiwada-shi, Japan, 596-8501
        • Research Site
      • Kitakyushu, Japan, 802-0052
        • Research Site
      • Kiyose-shi, Japan, 204-8585
        • Research Site
      • Kokubunji-shi, Japan, 185-0014
        • Research Site
      • Kyoto, Japan, 612-8555
        • Research Site
      • Kyoto, Japan, 601-8213
        • Research Site
      • Meguro-ku, Japan, 153-0051
        • Research Site
      • Nagoya, Japan, 457-0866
        • Research Site
      • Nankoku-shi, Japan, 783-8509
        • Research Site
      • Obihiro, Japan, 080-0017
        • Research Site
      • Omuta-shi, Japan, 837-0911
        • Research Site
      • Osaka, Japan, 530-0001
        • Research Site
      • Osaka, Japan, 531-0073
        • Research Site
      • Osaka, Japan, 551-0032
        • Research Site
      • Saga, Japan, 849-0917
        • Research Site
      • Sakaide-shi, Japan, 762-8550
        • Research Site
      • Sapporo, Japan, 064-0804
        • Research Site
      • Setagaya-ku, Japan, 157-0072
        • Research Site
      • Setagaya-ku, Japan, 158-0097
        • Research Site
      • Shibuya-ku, Japan, 150-0013
        • Research Site
      • Shimotsuga-gun, Japan, 321-0293
        • Research Site
      • Shinagawa-ku, Japan, 140-8522
        • Research Site
      • Shinagawa-ku, Japan, 140-0001
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Research Site
      • Shinjuku-ku, Japan, 160-0004
        • Research Site
      • Takarazuka-shi, Japan, 665-0827
        • Research Site
      • Tanabe-shi, Japan, 646-8558
        • Research Site
      • Toon-shi, Japan, 791-0281
        • Research Site
      • Toshima-ku, Japan, 170-0003
        • Research Site
      • Toshima-ku, Japan, 171-0014
        • Research Site
      • Toshima-ku, Japan, 170-0002
        • Research Site
      • Tsuchiura-shi, Japan, 300-8585
        • Research Site
      • Utsunomiya, Japan, 329-1193
        • Research Site
      • Yanagawa-shi, Japan, 832-0059
        • Research Site
      • Yokohama, Japan, 232-0024
        • Research Site
      • Yokohama, Japan, 240-8555
        • Research Site
      • Yokohama, Japan, 223-0059
        • Research Site
      • Yokohama, Japan, 231-8682
        • Research Site
      • Ōita, Japan, 870-8511
        • Research Site
  • New Zealand
      • Auckland, New Zealand, 0626
        • Research Site
      • Grafton, New Zealand, 1010
        • Research Site
      • Nawton, New Zealand, 3200
        • Research Site
      • Nelson, New Zealand, 7011
        • Research Site
      • Rotorua, New Zealand, 3040
        • Research Site
      • Wellington, New Zealand, 6021
        • Research Site
  • Peru
      • Lima, Peru, LIMA 31
        • Research Site
      • Lima, Peru, 15046
        • Research Site
      • Lima, Peru, 15036
        • Research Site
      • Lima, Peru, 15088
        • Research Site
      • Lima, Peru, LIMA 21
        • Research Site
      • Lima, Peru, 15131
        • Research Site
      • Piura, Peru, 20001
        • Research Site
  • Polen
      • Bialystok, Polen, 15-044
        • Research Site
      • Bialystok, Polen, 15-430
        • Research Site
      • Bydgoszcz, Polen, 85-079
        • Research Site
      • Częstochowa, Polen, 42-217
        • Research Site
      • Karczew, Polen, 05-480
        • Research Site
      • Katowice, Polen, 40-648
        • Research Site
      • Kielce, Polen, 25-734
        • Research Site
      • Krakow, Polen, 31-011
        • Research Site
      • Krakow, Polen, 30-727
        • Research Site
      • Krakow, Polen, 31-141
        • Research Site
      • Piaseczno, Polen, 05-500
        • Research Site
      • Poznan, Polen, 60-693
        • Research Site
      • Poznan, Polen, 61-578
        • Research Site
      • Poznan, Polen, 60-214
        • Research Site
      • Rzeszów, Polen, 35-051
        • Research Site
      • Rzeszów, Polen, 35-205
        • Research Site
      • Rzeszów, Polen, 35-055
        • Research Site
      • Sosnowiec, Polen, 41-200
        • Research Site
      • Sosnowiec, Polen, 41-208
        • Research Site
      • Strzelce Opolskie, Polen, 47-100
        • Research Site
      • Szczecin, Polen, 70-111
        • Research Site
      • Tarnów, Polen, 33-100
        • Research Site
      • Wroclaw, Polen, 54-239
        • Research Site
      • Wroclaw, Polen, 53-301
        • Research Site
  • Puerto Rico
      • Caguas, Puerto Rico, 00726
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      • Guaynabo, Puerto Rico, 00968
        • Research Site
      • San Juan, Puerto Rico, 00918
        • Research Site
  • Romania
      • Brasov, Romania, 500283
        • Research Site
      • Brasov, Romania, 500051
        • Research Site
      • Brasov, Romania, 500366
        • Research Site
      • Bucharest, Romania, 050159
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      • Timișoara, Romania, 300002
        • Research Site
  • Spania
      • Barcelona, Spania, 08017
        • Research Site
      • Benalmádena, Spania, 29631
        • Research Site
      • Coslada, Spania, 28822
        • Research Site
      • L'Hospitalet de Llobregat, Spania, 08907
        • Research Site
      • Madrid, Spania, 28031
        • Research Site
      • Madrid, Spania, 28007
        • Research Site
      • Marbella (Málaga), Spania, 29603
        • Research Site
      • Málaga, Spania, 29010
        • Research Site
      • Pozuelo de Alarcón, Spania, 28223
        • Research Site
      • Santander, Spania, 39008
        • Research Site
      • Valencia, Spania, 46026
        • Research Site
      • Zaragoza, Spania, 50009
        • Research Site
      • Zaragoza, Spania, 50015
        • Research Site
  • Sør -Korea
      • Cheongju-si, Sør -Korea, 28644
        • Research Site
      • Gangwon-do, Sør -Korea, 26426
        • Research Site
      • Jeonju, Sør -Korea, 54907
        • Research Site
      • Seoul, Sør -Korea, 03722
        • Research Site
      • Seoul, Sør -Korea, 05505
        • Research Site
      • Seoul, Sør -Korea, 06591
        • Research Site
      • Seoul, Sør -Korea, 03312
        • Research Site
      • Suwon, Sør -Korea, 16499
        • Research Site
      • Uijeongbu-si, Sør -Korea, 11765
        • Research Site
      • Ulsan, Sør -Korea, 44033
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Research Site
      • Kaohsiung City, Taiwan, 833
        • Research Site
      • New Taipei City, Taiwan, 23561
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
      • Taipei, Taiwan, 110
        • Research Site
      • Taoyuan, Taiwan
        • Research Site
  • Thailand
      • Bang Kra So, Thailand, 11000
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Chanthaburi, Thailand, 22000
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Muang, Thailand, 55000
        • Research Site
      • Mueang, Thailand, 20000
        • Research Site
  • Ungarn
      • Balassagyarmat, Ungarn, 2660
        • Research Site
      • Budapest, Ungarn, 1204
        • Research Site
      • Edelény, Ungarn, 3780
        • Research Site
      • Encs, Ungarn, 3860
        • Research Site
      • Gödöllő, Ungarn, 2100
        • Research Site
      • Hajdúnánás, Ungarn, 4080
        • Research Site
      • Komárom, Ungarn, 2900
        • Research Site
      • Pécs, Ungarn, 7635
        • Research Site
      • Szeged, Ungarn, 6720
        • Research Site
      • Szeged, Ungarn, 6722
        • Research Site
      • Szigetvár, Ungarn, 7900
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Ho Chi Minh City, Vietnam, 70000
        • Research Site
      • Hochiminh, Vietnam, 700000
        • Research Site
      • Hà Nội, Vietnam, 100000
        • 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. Aktuelle bevis på kronisk obstruktiv lungesykdom (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 langtidsvirkende muskarinantagonist (LAMA), enten alene eller som en del av en inhalasjonskombinasjonsbehandling, i de 12 ukene før V1.

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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24
Tidsramme: Week 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (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 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 the 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 the 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
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
Pooled (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization , or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was considered severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations
Tidsramme: Up to 52 weeks
Rate of moderate or severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate asthma exacerbation was a worsening of symptoms that resulted in an additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): 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 D5982C00007 and D5982C00008 (NCT04609904). 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 or 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 (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Tidsramme: Week 24
Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24
Tidsramme: Week 24
Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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

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)

15. desember 2020

Primær fullføring (Faktiske)

21. mars 2025

Studiet fullført (Faktiske)

21. 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)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D5982C00007
  • 2020-001520-34 (EudraCT-nummer)
  • 2023-505787-11 (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 sponsede 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