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Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

26. oktober 2016 opdateret af: GlaxoSmithKline

A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

600

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • GSK Investigational Site
      • Jasper, Alabama, Forenede Stater, 35501
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • GSK Investigational Site
      • Tempe, Arizona, Forenede Stater, 85282
        • GSK Investigational Site
    • California
      • Berkeley, California, Forenede Stater, 94705
        • GSK Investigational Site
      • Carmichael, California, Forenede Stater, 95608
        • GSK Investigational Site
      • Fullerton, California, Forenede Stater, 92835
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90822
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90048
        • GSK Investigational Site
      • Murrieta, California, Forenede Stater, 92562
        • GSK Investigational Site
      • Rancho Mirage, California, Forenede Stater, 92270
        • GSK Investigational Site
      • Riverside, California, Forenede Stater, 92805
        • GSK Investigational Site
      • Sacramento, California, Forenede Stater, 95823
        • GSK Investigational Site
      • San Diego, California, Forenede Stater, 92103
        • GSK Investigational Site
      • San Diego, California, Forenede Stater, 92120
        • GSK Investigational Site
      • San Jose, California, Forenede Stater, 95117
        • GSK Investigational Site
      • Sepulveda, California, Forenede Stater, 91343
        • GSK Investigational Site
      • Stockton, California, Forenede Stater, 95207
        • GSK Investigational Site
      • Torrance, California, Forenede Stater, 90509
        • GSK Investigational Site
      • Vista, California, Forenede Stater, 92083
        • GSK Investigational Site
      • Walnut Creek, California, Forenede Stater, 94598
        • GSK Investigational Site
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • GSK Investigational Site
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • GSK Investigational Site
      • Denver, Colorado, Forenede Stater, 80230
        • GSK Investigational Site
      • Englewood, Colorado, Forenede Stater, 80112
        • GSK Investigational Site
      • Fort Collins, Colorado, Forenede Stater, 80528
        • GSK Investigational Site
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06105
        • GSK Investigational Site
      • Stamford, Connecticut, Forenede Stater, 06902
        • GSK Investigational Site
      • Waterbury, Connecticut, Forenede Stater, 06708
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • GSK Investigational Site
      • Brandon, Florida, Forenede Stater, 33511
        • GSK Investigational Site
      • Deland, Florida, Forenede Stater, 32720
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • GSK Investigational Site
      • Largo, Florida, Forenede Stater, 33770
        • GSK Investigational Site
      • Longwood, Florida, Forenede Stater, 32779
        • GSK Investigational Site
      • Melbourne, Florida, Forenede Stater, 32935
        • GSK Investigational Site
      • Panama City, Florida, Forenede Stater, 32405
        • GSK Investigational Site
      • Pensacola, Florida, Forenede Stater, 32504
        • GSK Investigational Site
      • Tamarac, Florida, Forenede Stater, 33321
        • GSK Investigational Site
      • Tampa, Florida, Forenede Stater, 33613
        • GSK Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33409
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • GSK Investigational Site
      • Decatur, Georgia, Forenede Stater, 30033
        • GSK Investigational Site
    • Idaho
      • Coeur D'Alene, Idaho, Forenede Stater, 83814
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, Forenede Stater, 61761
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47710
        • GSK Investigational Site
      • South Bend, Indiana, Forenede Stater, 46617
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67207
        • GSK Investigational Site
    • Kentucky
      • Madisonville, Kentucky, Forenede Stater, 42431
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • GSK Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70119
        • GSK Investigational Site
      • Slidell, Louisiana, Forenede Stater, 70461
        • GSK Investigational Site
      • Sunset, Louisiana, Forenede Stater, 70584
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02135
        • GSK Investigational Site
    • Michigan
      • Cadillac, Michigan, Forenede Stater, 49601
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55402
        • GSK Investigational Site
    • Missouri
      • Jefferson City, Missouri, Forenede Stater, 65109
        • GSK Investigational Site
      • St. Charles, Missouri, Forenede Stater, 63301
        • GSK Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63141
        • GSK Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63122
        • GSK Investigational Site
    • Montana
      • Billings, Montana, Forenede Stater, 59102
        • GSK Investigational Site
      • Missoula, Montana, Forenede Stater, 59808
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89104
        • GSK Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08003
        • GSK Investigational Site
    • New York
      • Bronxville, New York, Forenede Stater, 10708
        • GSK Investigational Site
      • Cortland, New York, Forenede Stater, 14850
        • GSK Investigational Site
      • Larchmont, New York, Forenede Stater, 10538
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10016
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • GSK Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28207
        • GSK Investigational Site
      • Elizabeth City, North Carolina, Forenede Stater, 27909
        • GSK Investigational Site
      • High Point, North Carolina, Forenede Stater, 27262
        • GSK Investigational Site
      • Statesville, North Carolina, Forenede Stater, 28625
        • GSK Investigational Site
    • Ohio
      • Chardon, Ohio, Forenede Stater, 44024
        • GSK Investigational Site
      • Columbus, Ohio, Forenede Stater, 43215
        • GSK Investigational Site
      • Dayton, Ohio, Forenede Stater, 45406
        • GSK Investigational Site
      • Sylvania, Ohio, Forenede Stater, 43560
        • GSK Investigational Site
    • Oregon
      • Lake Oswego, Oregon, Forenede Stater, 97035
        • GSK Investigational Site
      • Medford, Oregon, Forenede Stater, 97504
        • GSK Investigational Site
      • Portland, Oregon, Forenede Stater, 97213
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • GSK Investigational Site
      • Downington, Pennsylvania, Forenede Stater, 19335
        • GSK Investigational Site
      • Elverson, Pennsylvania, Forenede Stater, 19520
        • GSK Investigational Site
      • Erie, Pennsylvania, Forenede Stater, 16508
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15218
        • GSK Investigational Site
      • Swarthmore, Pennsylvania, Forenede Stater, 19081
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406-7108
        • GSK Investigational Site
      • Gaffney, South Carolina, Forenede Stater, 29340
        • GSK Investigational Site
      • Greer, South Carolina, Forenede Stater, 29651
        • GSK Investigational Site
      • Simpsonville, South Carolina, Forenede Stater, 29681
        • GSK Investigational Site
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • GSK Investigational Site
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • GSK Investigational Site
      • Johnson City, Tennessee, Forenede Stater, 37601
        • GSK Investigational Site
      • Knoxville, Tennessee, Forenede Stater, 37920
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, Forenede Stater, 75110
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • GSK Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76104
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78217
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78205
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84102
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23225
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23229
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99204
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99207
        • GSK Investigational Site
      • Tacoma, Washington, Forenede Stater, 98405
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26505
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209-0996
        • GSK Investigational Site

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:

  • Diagnosis of COPD and a history of cigarette smoking.

Exclusion criteria:

  • Significant heart or lung disease not associated with COPD.
  • Significant stomach or intestinal disease.

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
Eksperimentel: Arm 1
Medicin: cilomilast

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
measure of lung function and quality of life in patients with COPD

Sekundære resultatmål

Resultatmål
exacerbations in patients with COPD

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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.

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. november 2004

Primær færdiggørelse (Faktiske)

1. januar 2007

Studieafslutning (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først indsendt

17. februar 2005

Først indsendt, der opfyldte QC-kriterier

17. februar 2005

Først opslået (Skøn)

18. februar 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIL103657

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Statistisk analyseplan
    Informations-id: CIL103657
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Studieprotokol
    Informations-id: CIL103657
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinisk undersøgelsesrapport
    Informations-id: CIL103657
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formular til informeret samtykke
    Informations-id: CIL103657
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individuelt deltagerdatasæt
    Informations-id: CIL103657
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasætspecifikation
    Informations-id: CIL103657
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

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 .

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bulgaria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner