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Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.

27. marts 2018 opdateret af: GlaxoSmithKline

A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Twice Daily Via DISKUS® Inhaler Versus Salmeterol 50mcg Twice Daily Via DISKUS® Inhaler on Bone Mineral Density in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

186

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
    • California
      • Berkeley, California, Forenede Stater, 94705
        • GSK Investigational Site
      • Fullerton, California, Forenede Stater, 92835
        • GSK Investigational Site
      • Rancho Mirage, California, Forenede Stater, 92270
        • GSK Investigational Site
      • San Diego, California, Forenede Stater, 92103
        • GSK Investigational Site
      • Walnut Creek, California, Forenede Stater, 94598
        • GSK Investigational Site
    • Colorado
      • 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
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • GSK Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32205
        • 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
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • GSK Investigational Site
      • North Chicago, Illinois, Forenede Stater, 60064
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67207
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02135
        • GSK Investigational Site
    • Michigan
      • Cadillac, Michigan, Forenede Stater, 49601
        • GSK Investigational Site
    • Missouri
      • Saint Charles, Missouri, Forenede Stater, 63301
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68124
        • GSK Investigational Site
    • New York
      • Bronxville, New York, Forenede Stater, 10708
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28207
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406-7108
        • 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
      • Kingsport, Tennessee, Forenede Stater, 37660
        • GSK Investigational Site
      • Milan, Tennessee, Forenede Stater, 38372
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, Forenede Stater, 75110
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78217
        • GSK Investigational Site
      • San Antonio, Texas, Forenede Stater, 78205
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23249
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23225
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Forenede Stater, 98226
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99204
        • GSK Investigational Site
      • Spokane, Washington, Forenede Stater, 99202
        • 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:

  • Established clinical history of COPD.
  • Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.
  • Smoking history of at least 10 pack-years, where both current and former smokers will be eligible.
  • Must have at least one native, evaluable hip.

Exclusion criteria:

  • History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.

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: Salmeterol 50 mcg BID
Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.
Medicin: Salmeterol 50 mcg BID
Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
Andre navne:
  • GR33343G
Enhed: DISKUS inhaler
Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
Eksperimentel: Fluticasone Propionate/Salmeterol 250/50 mcg BID
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
Enhed: DISKUS inhaler
Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
Medicin: Fluticasone Propionate/Salmeterol 250/50 mcg BID
Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
Andre navne:
  • CCI18781/GR33343G

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
Tidsramme: Baseline and Week 26, 52, 78, 104, 130, and 156
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Baseline and Week 26, 52, 78, 104, 130, and 156

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in BMD at the Total Hip
Tidsramme: Baseline and Week 26, 52, 78, 104, 130, and 156
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Baseline and Week 26, 52, 78, 104, 130, and 156

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

  • This study has not been published in the scientific literature.

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 (Faktiske)

28. april 2004

Primær færdiggørelse (Faktiske)

6. september 2007

Studieafslutning (Faktiske)

6. september 2007

Datoer for studieregistrering

Først indsendt

19. juli 2006

Først indsendt, der opfyldte QC-kriterier

19. juli 2006

Først opslået (Skøn)

21. juli 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SCO40041

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: SCO40041
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formular til informeret samtykke
    Informations-id: SCO40041
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Datasætspecifikation
    Informations-id: SCO40041
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Studieprotokol
    Informations-id: SCO40041
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individuelt deltagerdatasæt
    Informations-id: SCO40041
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annoteret sagsbetænkningsformular
    Informations-id: SCO40041
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk undersøgelsesrapport
    Informations-id: SCO40041
    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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