Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

16. november 2016 opdateret af: AstraZeneca
To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

804

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1143ABH
        • Almirall Investigational Sites#800
      • Buenos Aires, Argentina, C1221ADC
        • Almirall Investigational Sites#744
      • Buenos Aires, Argentina, C1405DCS
        • Almirall Investigational Sites#792
      • Buenos Aires, Argentina, C1416DVR
        • Almirall Investigational Sites#793
      • Buenos Aires, Argentina, C1424BSF
        • Almirall Investigational Sites#799
      • Buenos Aires, Argentina, C1425BEA
        • Almirall Investigational Sites#795
      • Buenos Aires, Argentina, C1425DTG
        • Almirall Investigational Sites#801
      • Buenos Aires, Argentina, C1426ABO
        • Almirall Investigational Sites#791
      • El Palomar, Argentina, 1684
        • Almirall Investigational Sites#797
      • La Plata, Argentina, 1900
        • Almirall Investigational Sites#740
      • Rosario, Argentina, S2000DBS
        • Almirall Investigational Sites#801
      • San Miguel de Tucuman, Argentina, 4000
        • Almirall Investigational Sites#796
      • Vicente López, Argentina, 1602
        • Almirall Investigational Sites#794
  • Australien
      • Adelaide, Australien, 5061
        • Almirall Investigational Sites#807
      • Auchenflower, Australien, 2031
        • Almirall Investigational Sites#834
      • Bankstown, Australien, 2200
        • Almirall Investigational Sites#808
      • Boxhill, Australien, 3128
        • Almirall Investigational Sites#806
      • Cairns, Australien, 4870
        • Almirall Investigational Sites#814
      • Camperdown, Australien, 2050
        • Almirall Investigational Sites#813
      • Carina Heights, Australien, 4152
        • Almirall Investigational Sites#811
      • Clayton, Australien, 3168
        • Almirall Investigational Sites#803
      • Kippa Ring, Australien, 4021
        • Almirall Investigational Sites#809
      • Nedlands, Australien, 6009
        • Almirall Investigational Sites#8121
      • Nedlands, Australien, 6009
        • Almirall Investigational Sites#812
      • Toorak Gardens, Australien, 5065
        • Almirall Investigational Sites#805
      • Woodville, Australien, 5011
        • Almirall Investigational Sites#815
  • Canada
      • Edmonton, Canada, T5X 4Z9
        • Almirall Investigational Sites#823
      • Kelowna, Canada, V1Y 9L8
        • Almirall Investigational Sites#818
      • Montreal, Canada, H4J 1C5
        • Almirall Investigational Sites#822
      • Niagara Falls, Canada, L2G 1J4
        • Almirall Investigational Sites#817
      • Ottawa, Canada, K1Y 4E9
        • Almirall Investigational Sites#821
      • Ottawa, Canada, K1Y 4G2
        • Almirall Investigational Sites#935
      • Toronto, Ontario, Canada, M6H 3M2
        • Almirall Investigational Sites#820
  • Forenede Stater
    • Alabama
      • Jasper, Alabama, Forenede Stater, 35501
        • Almirall Investigational Sites#926
      • Ozark, Alabama, Forenede Stater, 36360
        • Almirall Investigational Sites#858
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85023
        • Almirall Investigational Sites#900
      • Tucson, Arizona, Forenede Stater, 85715
        • Almirall Investigational Sites#899
      • Tucson, Arizona, Forenede Stater, 85723
        • Almirall Investigational Sites#855
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205-7199
        • Almirall Investigational Sites#879
    • California
      • Carmichael, California, Forenede Stater, 95837
        • Almirall Investigational Sites#932
      • Encinitas, California, Forenede Stater, 92024
        • Almirall Investigational Sites#904
      • Fullerton, California, Forenede Stater, 92835
        • Almirall Investigational Sites#903
      • Los Angeles, California, Forenede Stater, 90048
        • Almirall Investigational Sites#930
      • Los Angeles, California, Forenede Stater, 90095-1690
        • Almirall Investigational Sites#922
      • North Hills, California, Forenede Stater, 91343
        • Almirall Investigational Sites#893
      • Rancho Mirage, California, Forenede Stater, 92270
        • Almirall Investigational Sites#871
      • Riverside, California, Forenede Stater, 92506
        • Almirall Investigational Sites#902
      • San Diego, California, Forenede Stater, 92120
        • Almirall Investigational Sites#850
      • San Diego, California, Forenede Stater, 92120
        • Almirall Investigational Sites#897
      • Torrance, California, Forenede Stater, 90509
        • Almirall Investigational Sites#924
      • Walnut Creek, California, Forenede Stater, 94598
        • Almirall Investigational Sites#882
    • Colorado
      • Denver, Colorado, Forenede Stater, 80206
        • Almirall Investigational Sites#895
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Almirall Investigational Sites#880
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Almirall Investigational Sites#888
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater, 06708
        • Almirall Investigational Sites#952
    • Florida
      • Bay Pines, Florida, Forenede Stater, 33744
        • Almirall Investigational Sites#844
      • Clearwater, Florida, Forenede Stater, 33765
        • Almirall Investigational Sites#863
      • Deland, Florida, Forenede Stater, 32720
        • Almirall Investigational Sites#152
      • Melbourne, Florida, Forenede Stater, 32935
        • Almirall Investigational Sites#8533
      • Tamarac, Florida, Forenede Stater, 33321
        • Almirall Investigational Sites#920
      • Tampa, Florida, Forenede Stater, 33603
        • Almirall Investigational Sites#894
      • Tampa, Florida, Forenede Stater, 33613
        • Almirall Investigational Sites#889
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Almirall Investigational Sites#890
      • Decatur, Georgia, Forenede Stater, 30033
        • Almirall Investigational Sites#907
      • Gainesville, Georgia, Forenede Stater, 30501
        • Almirall Investigational Sites#931
      • Marietta, Georgia, Forenede Stater, 30060
        • Almirall Investigational Sites#849
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Almirall Investigational Sites#933
      • Hines, Illinois, Forenede Stater, 60141
        • Almirall Investigational Sites#872
      • River Forest, Illinois, Forenede Stater, 60305
        • Almirall Investigational Sites#892
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47714
        • Almirall Investigational Sites#864
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42101
        • Almirall Investigational Sites#876
      • Florence, Kentucky, Forenede Stater, 41042
        • Almirall Investigational Sites#923
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Almirall Investigational Sites#866
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Almirall Investigational Sites#911
    • Maine
      • Biddeford, Maine, Forenede Stater, 04005
        • Almirall Investigational Sites#883
      • Lewiston, Maine, Forenede Stater, 04240
        • Almirall Investigational Sites#976
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Almirall Investigational Sites#843
    • Michigan
      • Cadillac, Michigan, Forenede Stater, 49601
        • Almirall Investigational Sites#868
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55402
        • Almirall Investigational Sites#884
    • Missouri
      • Saint Charles, Missouri, Forenede Stater, 63301
        • Almirall Investigational Sites#916
    • Montana
      • Butte, Montana, Forenede Stater, 59701
        • Almirall Investigational Sites#906
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198-2465
        • Almirall Investigational Sites#909
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08003
        • Almirall Investigational Sites#846
      • Newark, New Jersey, Forenede Stater, 07112
        • Almirall Investigational Sites#885
      • Summit, New Jersey, Forenede Stater, 07901
        • Almirall Investigational Sites#921
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Almirall Investigational Sites#896
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Almirall Investigational Sites#861
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Almirall Investigational Sites#919
      • Elizabeth City, North Carolina, Forenede Stater, 27909
        • Almirall Investigational Sites#878
      • Williamston, North Carolina, Forenede Stater, 29697
        • Almirall Investigational Sites#842
      • Winston Salem, North Carolina, Forenede Stater, 27103
        • Almirall Investigational Sites#915
    • Ohio
      • Cincinatti, Ohio, Forenede Stater, 45231
        • Almirall Investigational Sites#848
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Almirall Investigational Sites#870
      • Columbus, Ohio, Forenede Stater, 43215
        • Almirall Investigational Sites#847
      • Sylvania, Ohio, Forenede Stater, 43560
        • Almirall Investigational Sites#928
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401
        • Almirall Investigational Sites#905
      • Medford, Oregon, Forenede Stater, 97504
        • Almirall Investigational Sites#860
      • Medford, Oregon, Forenede Stater, 97504
        • Almirall Investigational Sites#886
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Almirall Investigational Sites#910
      • Greer, South Carolina, Forenede Stater, 29651
        • Almirall Investigational Sites#918
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Almirall Investigational Sites#898
      • Fort Worth, Texas, Forenede Stater, 76104
        • Almirall Investigational Sites#854
      • Houston, Texas, Forenede Stater, 77030
        • Almirall Investigational Sites#875
      • San Antonio, Texas, Forenede Stater, 78229
        • Almirall Investigational Sites#881
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23225
        • Almirall Investigational Sites#951
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Almirall Investigational Sites#856
  • Mexico
      • Monterrey, Mexico, 64460
        • Almirall Investigational Sites#827
      • Zapopan, Mexico, 452000
        • Almirall Investigational Sites#826
  • New Zealand
      • Auckland, New Zealand, 1640
        • Almirall Investigational Sites#936
      • Grafton, New Zealand, 1001
        • Almirall Investigational Sites#830
      • Tauranga, New Zealand, 3140
        • Almirall Investigational Sites#832
  • Sydafrika
      • Amanzimtoti, Sydafrika, 4125
        • Almirall Investigational Sites#833
      • Bloemfontain, Sydafrika, 9317
        • Almirall Investigational Sites#836
      • Bloemfontein, Sydafrika, 9301
        • Almirall Investigational Sites#841
      • Cape Town, Sydafrika, 7130
        • Almirall Investigational Sites#839
      • Cape Town, Sydafrika, 7700
        • Almirall Investigational Sites#835
      • Cape Town, Sydafrika, 7764
        • Almirall Investigational Sites#837
      • Cape Town, Sydafrika, 8001
        • Almirall Investigational Sites#840
      • Durban, Sydafrika, 4001
        • Almirall Investigational Sites#834
      • Johannesburg, Sydafrika, 2193
        • Almirall Investigational Sites#838

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

  • History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Placebo ved inhalation
Medicin: Placebo
Placebo én gang dagligt via inhalation: 1 sug om morgenen i 52 uger
Eksperimentel: Aclidinium 200 μg én gang dagligt
Aclidiniumbromid 200 μg én gang dagligt ved inhalation
Medicin: Aclidinium bromide
Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trough FEV1 (L) at 28 Weeks on Treatment
Tidsramme: 28 weeks
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 28 weeks
28 weeks
Trough FEV1 (L) at 12 Weeks on Treatment
Tidsramme: 12 weeks
Trough FEV1 (mean FEV1 value of the two highest FEV1 readings measured at 23 and 24 hours after inhalation) at 12 weeks
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af patienter, der opnåede et fald på mindst 4 enheder fra baseline i den samlede SGRQ-score ved 52 uger efter behandling
Tidsramme: 52 uger
Procentdel af patienter, der opnåede en klinisk relevant forbedring i sundhedsrelateret livskvalitet efter 52 uger, målt ved et fald på mindst 4 enheder fra baseline i St George's Respiratory Questionnaire (SGRQ) totalscore
52 uger
Time to First Moderate or Severe COPD Exacerbation at 52 Weeks on Treatment
Tidsramme: 52 weeks
Time to first moderate or severe exacerbation: Increase of COPD symptoms during at least 2 consecutive days, treated with antibiotics and/or systemic corticosteroids or an increase in dose of systemic corticosteroids, or leading to hospitalisation.
52 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2006

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først indsendt

28. juli 2006

Først indsendt, der opfyldte QC-kriterier

28. juli 2006

Først opslået (Skøn)

31. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M/34273/31
  • ACCLAIM II (Anden identifikator: Almirall,S.A.)
  • CT000742 (Anden identifikator: Almirall,S.A.)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Congo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner