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Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate

2. februar 2017 opdateret af: GlaxoSmithKline

Randomized, Double-Blind Comparison of Advair 100/50 BID vs Salmeterol BID vs Albuterol QID in Subjects With ARG/ARG Genotype 12 Years of Age and Older With Presistent Asthma on Short-Acting Beta2-Agonists Alone

This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly or a B-16 Arg/Gly Genotype and are Treated With Fluticasone Propionate/Salmeterol DISKUS™ Combination Product 100/50mcg or Salmeterol DISKUS 50 mcg BID

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

547

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
      • Mobile, Alabama, Forenede Stater, 36608
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • GSK Investigational Site
    • California
      • Fresno, California, Forenede Stater, 93720
        • GSK Investigational Site
      • Fullerton, California, Forenede Stater, 92835
        • GSK Investigational Site
      • Huntington Beach, California, Forenede Stater, 92647
        • GSK Investigational Site
      • Inglewood, California, Forenede Stater, 90301
        • GSK Investigational Site
      • Irvine, California, Forenede Stater, 92618
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90808
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90025
        • GSK Investigational Site
      • Los Angeles, California, Forenede Stater, 90048
        • GSK Investigational Site
      • Orange, California, Forenede Stater, 92868
        • GSK Investigational Site
      • Spring Valley, California, Forenede Stater, 91978
        • GSK Investigational Site
      • Stockton, California, Forenede Stater, 95207
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • GSK Investigational Site
      • Denver, Colorado, Forenede Stater, 80206
        • GSK Investigational Site
      • Denver, Colorado, Forenede Stater, 80209
        • GSK Investigational Site
      • Lakewood, Colorado, Forenede Stater, 80401
        • GSK Investigational Site
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • GSK Investigational Site
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater, 06708
        • GSK Investigational Site
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33134
        • GSK Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32207
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33136
        • GSK Investigational Site
      • Miami, Florida, Forenede Stater, 33176
        • GSK Investigational Site
      • Orlando, Florida, Forenede Stater, 32806
        • GSK Investigational Site
      • Sarasota, Florida, Forenede Stater, 34233
        • GSK Investigational Site
      • South Miami, Florida, Forenede Stater, 33143
        • GSK Investigational Site
      • Tallahassee, Florida, Forenede Stater, 32308
        • GSK Investigational Site
      • Tampa, Florida, Forenede Stater, 33613
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30310
        • GSK Investigational Site
      • Lawrenceville, Georgia, Forenede Stater, 30045
        • GSK Investigational Site
      • Lilburn, Georgia, Forenede Stater, 30047
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • GSK Investigational Site
      • Chicago, Illinois, Forenede Stater, 60612
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46208
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66210
        • GSK Investigational Site
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • GSK Investigational Site
      • Metairie, Louisiana, Forenede Stater, 70002
        • GSK Investigational Site
      • Shreveport, Louisiana, Forenede Stater, 71105
        • GSK Investigational Site
      • Shreveport, Louisiana, Forenede Stater, 71104
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • GSK Investigational Site
      • Baltimore, Maryland, Forenede Stater, 21237
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • GSK Investigational Site
      • North Dartmouth, Massachusetts, Forenede Stater, 02747
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • GSK Investigational Site
      • St. Louis, Missouri, Forenede Stater, 63141
        • GSK Investigational Site
      • Warrensburg, Missouri, Forenede Stater, 64093
        • GSK Investigational Site
    • Nebraska
      • Papillion, Nebraska, Forenede Stater, 68046
        • GSK Investigational Site
    • New Jersey
      • Hackensack, New Jersey, Forenede Stater, 07601
        • GSK Investigational Site
      • Newark, New Jersey, Forenede Stater, 07103-2499
        • GSK Investigational Site
    • New York
      • Bayshore, New York, Forenede Stater, 11706
        • GSK Investigational Site
      • New York, New York, Forenede Stater, 10021
        • GSK Investigational Site
      • Rochester, New York, Forenede Stater, 14618
        • GSK Investigational Site
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19143
        • GSK Investigational Site
      • Upland, Pennsylvania, Forenede Stater, 19013
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • GSK Investigational Site
      • Charleston, South Carolina, Forenede Stater, 29414
        • GSK Investigational Site
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • GSK Investigational Site
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • GSK Investigational Site
      • Knoxville, Tennessee, Forenede Stater, 37920
        • GSK Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37203-1424
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, Forenede Stater, 75110
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75246
        • GSK Investigational Site
      • Dallas, Texas, Forenede Stater, 75230
        • GSK Investigational Site
      • El Paso, Texas, Forenede Stater, 79925
        • GSK Investigational Site
      • El Paso, Texas, Forenede Stater, 79902
        • GSK Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76104
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77054
        • GSK Investigational Site
      • Kerrville, Texas, Forenede Stater, 78028
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • GSK Investigational Site
    • Vermont
      • South Burlington, Vermont, Forenede Stater, 05403
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23229
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • GSK Investigational Site
      • Kirkland, Washington, Forenede Stater, 98034
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • GSK Investigational Site
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • GSK Investigational Site
      • Milwaukee, Wisconsin, Forenede Stater, 53209-0996
        • GSK Investigational Site
      • Milwaukee, Wisconsin, Forenede Stater, 53219
        • GSK Investigational Site
      • West Allis, Wisconsin, Forenede Stater, 53227
        • GSK Investigational Site
  • Kenya
      • Nairobi, Kenya, 00200
        • GSK Investigational Site
  • Peru
      • Lima, Peru, Lima 1
        • GSK Investigational Site
    • Lima
      • San Isidro, Lima, Peru, Lima 27
        • GSK Investigational Site
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • GSK Investigational Site
      • Ponce, Puerto Rico, 00716
        • 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 og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Diagnosis of persistent asthma for 3 months.
  • Use of short-acting beta-agonist medication like VENTOLIN.

Exclusion criteria:

  • Hospitalization for asthma 6 months before study.
  • Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
  • Current use of inhaled or oral corticosteroids.

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
Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT

Sekundære resultatmål

Resultatmål
Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT

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. oktober 2004

Primær færdiggørelse (Faktiske)

1. januar 2007

Studieafslutning (Faktiske)

1. januar 2007

Datoer for studieregistrering

Først indsendt

3. februar 2005

Først indsendt, der opfyldte QC-kriterier

3. februar 2005

Først opslået (Skøn)

4. februar 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SFA100062

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. Formular til informeret samtykke
    Informations-id: SFA100062
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annoteret sagsbetænkningsformular
    Informations-id: SFA100062
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informations-id: SFA100062
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Studieprotokol
    Informations-id: SFA100062
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individuelt deltagerdatasæt
    Informations-id: SFA100062
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasætspecifikation
    Informations-id: SFA100062
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk undersøgelsesrapport
    Informations-id: SFA100062
    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 .

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