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

Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations

19. januar 2017 opdateret af: GlaxoSmithKline

A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

797

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • GSK Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2M 3W5
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0G 1G0
        • GSK Investigational Site
      • Holyrood, Newfoundland and Labrador, Canada, A0A 2R0
        • GSK Investigational Site
    • Ontario
      • Grimsby, Ontario, Canada, L3M 1P3
        • GSK Investigational Site
      • London, Ontario, Canada, N6C 4Y7
        • GSK Investigational Site
      • Thunder Bay, Ontario, Canada, P7A 4V7
        • GSK Investigational Site
    • Quebec
      • Bonaventure, Quebec, Canada, G0C 1E0
        • GSK Investigational Site
      • Chandler, Quebec, Canada, G0C 1K0
        • GSK Investigational Site
      • Charlesbourg, Quebec, Canada, G1G 4A2
        • GSK Investigational Site
      • Gatineau, Quebec, Canada, J8Y 6S8
        • GSK Investigational Site
      • Saint Leonard, Quebec, Canada, H1S 3A9
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
      • Trois Rivieres, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • Forenede Stater
    • Alabama
      • Jasper, Alabama, Forenede Stater, 35501
        • GSK Investigational Site
      • Mobile, Alabama, Forenede Stater, 36608
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • GSK Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85013
        • GSK Investigational Site
    • California
      • Berkeley, California, Forenede Stater, 94705
        • GSK Investigational Site
      • Fullerton, California, Forenede Stater, 92835
        • GSK Investigational Site
      • Riverside, California, Forenede Stater, 92506
        • GSK Investigational Site
      • Sacramento, California, Forenede Stater, 95825
        • GSK Investigational Site
      • San Diego, California, Forenede Stater, 92123
        • GSK Investigational Site
      • Vista, California, Forenede Stater, 92084
        • GSK Investigational Site
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80528
        • GSK Investigational Site
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06902
        • GSK Investigational Site
    • Florida
      • Atlantis, Florida, Forenede Stater, 33462
        • GSK Investigational Site
      • Clear Water, Florida, Forenede Stater, 33756
        • GSK Investigational Site
      • Deland, Florida, Forenede Stater, 32720
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • GSK Investigational Site
      • Pensacola, Florida, Forenede Stater, 32504
        • GSK Investigational Site
      • Sarasota, Florida, Forenede Stater, 34239
        • GSK Investigational Site
      • Tamarac, Florida, Forenede Stater, 33321
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • GSK Investigational Site
      • Woodstock, Georgia, Forenede Stater, 30189
        • GSK Investigational Site
    • Illinois
      • Springfield, Illinois, Forenede Stater, 62702
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46154
        • GSK Investigational Site
      • Evansville, Indiana, Forenede Stater, 47714
        • GSK Investigational Site
      • Evansville, Indiana, Forenede Stater, 47710
        • GSK Investigational Site
      • Indianapolis, Indiana, Forenede Stater, 46208
        • GSK Investigational Site
      • South Bend, Indiana, Forenede Stater, 46617
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • GSK Investigational Site
    • Kansas
      • Olathe, Kansas, Forenede Stater, 66061
        • 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, 70112
        • GSK Investigational Site
      • Shreveport, Louisiana, Forenede Stater, 71103
        • GSK Investigational Site
      • Sunset, Louisiana, Forenede Stater, 70584
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02135
        • GSK Investigational Site
    • Michigan
      • St. Joseph, Michigan, Forenede Stater, 49085
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
        • GSK Investigational Site
      • Jefferson City, Missouri, Forenede Stater, 65101
        • GSK Investigational Site
      • St. Charles, Missouri, Forenede Stater, 63301
        • GSK Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63110
        • GSK Investigational Site
    • Montana
      • Billings, Montana, Forenede Stater, 59102
        • GSK Investigational Site
      • Butte, Montana, Forenede Stater, 59701
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68131
        • GSK Investigational Site
      • Omaha, Nebraska, Forenede Stater, 68124
        • GSK Investigational Site
    • New Jersey
      • Absecon, New Jersey, Forenede Stater, 08201
        • GSK Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12205
        • GSK Investigational Site
      • Bayshore, New York, Forenede Stater, 11706
        • GSK Investigational Site
      • Ithaca, 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
      • Raleigh, North Carolina, Forenede Stater, 27612
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • GSK Investigational Site
      • Chardon, Ohio, Forenede Stater, 44024
        • GSK Investigational Site
      • Mogadore, Ohio, Forenede Stater, 44260
        • GSK Investigational Site
    • Oregon
      • Lake Oswego, Oregon, Forenede Stater, 97035
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16508
        • GSK Investigational Site
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • GSK Investigational Site
      • McKeesport, Pennsylvania, Forenede Stater, 15132
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15025
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • GSK Investigational Site
      • Providence, Rhode Island, Forenede Stater, 2909
        • GSK Investigational Site
    • South Carolina
      • 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
      • Kingsport, Tennessee, Forenede Stater, 37660
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75390-9016
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77074
        • GSK Investigational Site
      • New Braunfels, Texas, Forenede Stater, 78130
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78217
        • GSK Investigational Site
      • San Marcos, Texas, Forenede Stater, 78666
        • GSK Investigational Site
    • Virginia
      • Abingdon, Virginia, Forenede Stater, 24210
        • GSK Investigational Site
      • Lynchburg, Virginia, Forenede Stater, 24501
        • GSK Investigational Site
      • Newport News, Virginia, Forenede Stater, 23606
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23225
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Forenede Stater, 98226
        • GSK Investigational Site
      • Gig Harbor, Washington, Forenede Stater, 98335
        • GSK Investigational Site
      • Kirkland, Washington, Forenede Stater, 98034
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99204
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26505
        • GSK Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • GSK Investigational Site
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • 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.
  • Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
  • History of at least 1 COPD exacerbation in the 12 months prior to screening.
  • Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion criteria:

  • Diagnosis of asthma.
  • Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
  • Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
  • Lung resection surgery within 1 year of screening.
  • Abnormal and clinically significant ECG findings at screening.
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Rate of moderate/severe exacerbations over a 52 week treatment period

Sekundære resultatmål

Resultatmål
The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year

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.

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. december 2004

Primær færdiggørelse (Faktiske)

1. juni 2007

Studieafslutning (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først indsendt

22. juni 2005

Først indsendt, der opfyldte QC-kriterier

22. juni 2005

Først opslået (Skøn)

23. juni 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SCO100250

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. Datasætspecifikation
    Informations-id: SCO100250
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individuelt deltagerdatasæt
    Informations-id: SCO100250
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Studieprotokol
    Informations-id: SCO100250
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annoteret sagsbetænkningsformular
    Informations-id: SCO100250
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistisk analyseplan
    Informations-id: SCO100250
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formular til informeret samtykke
    Informations-id: SCO100250
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk undersøgelsesrapport
    Informations-id: SCO100250
    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 .

Abonner