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Study Of Asthma In Patients Of African Descent

16. januar 2017 opdateret af: GlaxoSmithKline

A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone

This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

479

Fase

  • Fase 4

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, 35205
        • GSK Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35209
        • GSK Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35294-0012
        • GSK Investigational Site
      • Mobile, Alabama, Forenede Stater, 36608
        • GSK Investigational Site
      • Montgomery, Alabama, Forenede Stater, 36106
        • GSK Investigational Site
      • Muscle Shoals, Alabama, Forenede Stater, 35662
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • GSK Investigational Site
      • Little Rock, Arkansas, Forenede Stater, 72204
        • GSK Investigational Site
    • California
      • Long Beach, California, Forenede Stater, 90806
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90048
        • GSK Investigational Site
      • Palmdale, California, Forenede Stater, 93551
        • GSK Investigational Site
      • Riverside, California, Forenede Stater, 92506
        • GSK Investigational Site
      • San Francisco, California, Forenede Stater, 94102
        • GSK Investigational Site
      • Stockton, California, Forenede Stater, 95207
        • GSK Investigational Site
      • Walnut Creek, California, Forenede Stater, 94598
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06105
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • GSK Investigational Site
      • Washington, District of Columbia, Forenede Stater, 20060
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32205
        • GSK Investigational Site
      • Tallahassee, Florida, Forenede Stater, 32308
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • GSK Investigational Site
      • Columbus, Georgia, Forenede Stater, 31904
        • GSK Investigational Site
      • Decatur, Georgia, Forenede Stater, 30030
        • GSK Investigational Site
      • Martinez, Georgia, Forenede Stater, 30907
        • GSK Investigational Site
      • Savannah, Georgia, Forenede Stater, 31406
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • GSK Investigational Site
      • Flossmoor, Illinois, Forenede Stater, 60422
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • GSK Investigational Site
      • Metairie, Louisiana, Forenede Stater, 70006
        • GSK Investigational Site
      • Sunset, Louisiana, Forenede Stater, 70584
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21236
        • GSK Investigational Site
      • Bethesda, Maryland, Forenede Stater, 20814
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • GSK Investigational Site
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • GSK Investigational Site
      • Picayune, Mississippi, Forenede Stater, 39466
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • GSK Investigational Site
    • New Jersey
      • Verona, New Jersey, Forenede Stater, 07044
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, Forenede Stater, 11215
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10032
        • GSK Investigational Site
      • West Sayville, New York, Forenede Stater, 11796
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • GSK Investigational Site
      • Charlotte, North Carolina, Forenede Stater, 28204
        • GSK Investigational Site
      • Durham, North Carolina, Forenede Stater, 27710
        • GSK Investigational Site
      • Elizabeth City, North Carolina, Forenede Stater, 27909
        • GSK Investigational Site
      • High Point, North Carolina, Forenede Stater, 27262
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45231
        • GSK Investigational Site
      • Cleveland, Ohio, Forenede Stater, 44106
        • GSK Investigational Site
      • Sylvania, Ohio, Forenede Stater, 43560
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • GSK Investigational Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, Forenede Stater, 19406
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19102
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-6160
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • GSK Investigational Site
      • Charleston, South Carolina, Forenede Stater, 29406-7108
        • GSK Investigational Site
      • Greenville, South Carolina, Forenede Stater, 29607
        • GSK Investigational Site
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • GSK Investigational Site
      • Knoxville, Tennessee, Forenede Stater, 37909
        • GSK Investigational Site
      • Knoxville, Tennessee, Forenede Stater, 37920
        • GSK Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37203-1424
        • GSK Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37208
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78750
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75230
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77054
        • GSK Investigational Site
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23601
        • GSK Investigational Site
      • Norfolk, Virginia, Forenede Stater, 23507
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23225
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23229
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • 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

12 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • History of asthma for at least 6 months.
  • Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).

Exclusion criteria:

  • History of life-threatening asthma.
  • Hospitalized for asthma within 3 months prior to the study.
  • Current respiratory tract infection.
  • Will not be able to attend clinic visits for the entire length of the study.
  • Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).

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
Asthma exacerbation rate per patient per year

Sekundære resultatmål

Resultatmål
Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days

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. november 2004

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

1. februar 2005

Først indsendt, der opfyldte QC-kriterier

1. februar 2005

Først opslået (Skøn)

2. februar 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SFA103153

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. Individuelt deltagerdatasæt
    Informations-id: SFA103153
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formular til informeret samtykke
    Informations-id: SFA103153
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informations-id: SFA103153
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annoteret sagsbetænkningsformular
    Informations-id: SFA103153
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Studieprotokol
    Informations-id: SFA103153
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Klinisk undersøgelsesrapport
    Informations-id: SFA103153
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datasætspecifikation
    Informations-id: SFA103153
    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 .

Kliniske forsøg med fluticasone propionate/salmeterol powder

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner