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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. mars 2018 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

186

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Berkeley, California, Forente stater, 94705
        • GSK Investigational Site
      • Fullerton, California, Forente stater, 92835
        • GSK Investigational Site
      • Rancho Mirage, California, Forente stater, 92270
        • GSK Investigational Site
      • San Diego, California, Forente stater, 92103
        • GSK Investigational Site
      • Walnut Creek, California, Forente stater, 94598
        • GSK Investigational Site
    • Colorado
      • Fort Collins, Colorado, Forente stater, 80528
        • GSK Investigational Site
      • Wheat Ridge, Colorado, Forente stater, 80033
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06105
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33316
        • GSK Investigational Site
      • Jacksonville, Florida, Forente stater, 32205
        • GSK Investigational Site
      • Sarasota, Florida, Forente stater, 34239
        • GSK Investigational Site
      • Tamarac, Florida, Forente stater, 33321
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • GSK Investigational Site
      • North Chicago, Illinois, Forente stater, 60064
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Forente stater, 67207
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02135
        • GSK Investigational Site
    • Michigan
      • Cadillac, Michigan, Forente stater, 49601
        • GSK Investigational Site
    • Missouri
      • Saint Charles, Missouri, Forente stater, 63301
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68124
        • GSK Investigational Site
    • New York
      • Bronxville, New York, Forente stater, 10708
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28207
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Forente stater, 97213
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29406-7108
        • GSK Investigational Site
      • Greer, South Carolina, Forente stater, 29651
        • GSK Investigational Site
      • Simpsonville, South Carolina, Forente stater, 29681
        • GSK Investigational Site
      • Spartanburg, South Carolina, Forente stater, 29303
        • GSK Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Forente stater, 37660
        • GSK Investigational Site
      • Milan, Tennessee, Forente stater, 38372
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, Forente stater, 75110
        • GSK Investigational Site
      • San Antonio, Texas, Forente stater, 78217
        • GSK Investigational Site
      • San Antonio, Texas, Forente stater, 78205
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, Forente stater, 23249
        • GSK Investigational Site
      • Richmond, Virginia, Forente stater, 23225
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Forente stater, 98226
        • GSK Investigational Site
      • Spokane, Washington, Forente stater, 99204
        • GSK Investigational Site
      • Spokane, Washington, Forente stater, 99202
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Salmeterol 50 mcg BID
Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
Andre navn:
  • GR33343G
Enhet: 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.
Eksperimentell: 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.
Enhet: 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.
Legemiddel: 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 navn:
  • CCI18781/GR33343G

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. april 2004

Primær fullføring (Faktiske)

6. september 2007

Studiet fullført (Faktiske)

6. september 2007

Datoer for studieregistrering

Først innsendt

19. juli 2006

Først innsendt som oppfylte QC-kriteriene

19. juli 2006

Først lagt ut (Anslag)

21. juli 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. mars 2018

Sist bekreftet

1. mars 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SCO40041

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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
    Informasjonsidentifikator: SCO40041
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Skjema for informert samtykke
    Informasjonsidentifikator: SCO40041
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Datasettspesifikasjon
    Informasjonsidentifikator: SCO40041
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Studieprotokoll
    Informasjonsidentifikator: SCO40041
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasett for individuell deltaker
    Informasjonsidentifikator: SCO40041
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotert saksrapportskjema
    Informasjonsidentifikator: SCO40041
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Klinisk studierapport
    Informasjonsidentifikator: SCO40041
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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