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A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))

2. august 2018 oppdatert av: GlaxoSmithKline

A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week Treatment period. There will be a 7-day Follow-up period after the treatment period.

Studietype

Intervensjonell

Registrering (Faktiske)

528

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Bouge, Belgia, 5004
        • GSK Investigational Site
      • Brussels, Belgia, 1200
        • GSK Investigational Site
      • Bruxelles, Belgia, 1070
        • GSK Investigational Site
      • Edegem, Belgia, 2650
        • GSK Investigational Site
      • Genk, Belgia, 3600
        • GSK Investigational Site
      • Gent, Belgia, 9000
        • GSK Investigational Site
      • Gilly, Belgia, 6060
        • GSK Investigational Site
  • Den russiske føderasjonen
      • Chelyabinsk, Den russiske føderasjonen, 454034
        • GSK Investigational Site
      • Kazan, Den russiske føderasjonen, 420015
        • GSK Investigational Site
      • Kemerovo, Den russiske føderasjonen, 650000
        • GSK Investigational Site
      • Moscow, Den russiske føderasjonen, 115446
        • GSK Investigational Site
      • Moscow, Den russiske føderasjonen, 125367
        • GSK Investigational Site
      • Moscow, Den russiske føderasjonen, 115093
        • GSK Investigational Site
      • Yaroslavl, Den russiske føderasjonen, 150003
        • GSK Investigational Site
  • Filippinene
      • Jaro, Iloilo City, Filippinene, 5000
        • GSK Investigational Site
      • Lipa City, Filippinene, 4217
        • GSK Investigational Site
      • Quezon City, Filippinene, 1101
        • GSK Investigational Site
      • Quezon City, Filippinene, 1100
        • GSK Investigational Site
  • Frankrike
      • Bethune Cedex, Frankrike, 62408
        • GSK Investigational Site
      • Brest Cedex, Frankrike, 29609
        • GSK Investigational Site
      • Lille, Frankrike, 59000
        • GSK Investigational Site
      • Marseille Cedex 20, Frankrike, 13915
        • GSK Investigational Site
      • Montpellier cedex 5, Frankrike, 34295
        • GSK Investigational Site
      • Nice, Frankrike, 06002
        • GSK Investigational Site
      • Pessac cedex, Frankrike, 33604
        • GSK Investigational Site
  • Italia
    • Campania
      • Benevento, Campania, Italia, 82100
        • GSK Investigational Site
      • Salerno, Campania, Italia, 84100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italia, 00135
        • GSK Investigational Site
    • Lombardia
      • Sesto S. Giovanni MI, Lombardia, Italia, 20099
        • GSK Investigational Site
    • Puglia
      • Acquaviva Delle Fonti BA, Puglia, Italia, 70021
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italia, 56124
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italia, 06156
        • GSK Investigational Site
    • Veneto
      • Cittadella PD, Veneto, Italia, 35013
        • GSK Investigational Site
      • Verona, Veneto, Italia, 37134
        • GSK Investigational Site
  • Polen
      • Bialystok, Polen
        • GSK Investigational Site
      • Czestochowa, Polen, 42-200
        • GSK Investigational Site
      • Lodz, Polen, 93-329
        • GSK Investigational Site
      • Lodz, Polen, 92-107
        • GSK Investigational Site
      • Ostrow Wielkopolski, Polen, 63-400
        • GSK Investigational Site
      • Piekary Slaskie, Polen, 41-940
        • GSK Investigational Site
      • Wilkowice, Polen, 43-365
        • GSK Investigational Site
  • Spania
      • Alicante, Spania, 03114
        • GSK Investigational Site
      • Barakaldo (Vizcaya), Spania, 48903
        • GSK Investigational Site
      • Cáceres, Spania, 10003
        • GSK Investigational Site
      • Madrid, Spania, 28040
        • GSK Investigational Site
      • Pozuelo De Alarcón/Madrid, Spania, 28223
        • GSK Investigational Site
      • San Sebastián, Spania, 20014
        • GSK Investigational Site
      • Valencia, Spania, 46015
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 14057
        • GSK Investigational Site
      • Berlin, Tyskland, 10117
        • GSK Investigational Site
      • Berlin, Tyskland, 10787
        • GSK Investigational Site
      • Berlin, Tyskland, 10789
        • GSK Investigational Site
      • Hamburg, Tyskland, 20253
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Tyskland, 80809
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Tyskland, 60389
        • GSK Investigational Site
      • Frankfurt am Main, Hessen, Tyskland, 60596
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30159
        • GSK Investigational Site
    • Sachsen
      • Delitzsch, Sachsen, Tyskland, 04509
        • GSK Investigational Site
      • Dresden, Sachsen, Tyskland, 01307
        • GSK Investigational Site
      • Leipzig, Sachsen, Tyskland, 04207
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Tyskland, 39112
        • GSK Investigational Site
  • Ukraina
      • Cherkassy, Ukraina, 18009
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraina, 76018
        • GSK Investigational Site
      • Kharkiv, Ukraina, 61035
        • GSK Investigational Site
      • Kiev, Ukraina, 03680
        • GSK Investigational Site
      • Kyiv, Ukraina, 04107
        • 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:

  • Signed and dated written informed consent
  • Male or females ≥ 40 years of age
  • Established clinical history of COPD by ATS/ERS definition
  • Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
  • Former or current smoker > 10 pack years
  • Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)
  • have been hospitalised or have been treated with oral corticosteroids or antibiotics for their COPD within the last 3 years prior to Screening (Visit 1)

Exclusion Criteria:

  • Current diagnosis of asthma
  • Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
  • Lung volume reduction surgery within previous 12 months
  • Clinically significant abnormalities not due to COPD by chest x-ray
  • Hospitalized for poorly controlled COPD within 12 weeks of Screening
  • Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
  • Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
  • Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
  • Carcinoma not in complete remission for at least 5 years
  • Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
  • Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation - Known/suspected history of alcohol or drug abuse in the last 2 years
  • Women who are pregnant or lactating or plan to become pregnant
  • Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
  • Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
  • Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study - Non-compliance or inability to comply with study procedures or scheduled visits
  • Affiliation with investigator site

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: Fluticasone Furoate/Vilanterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
Legemiddel: Fluticasone Furoate 100mcg/Vilanterol 25mcg
Inhalation Powder
Aktiv komparator: Fluticasone Propionate/Salmeterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
Legemiddel: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Inhalation Powder

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
Tidsramme: Baseline and Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.
Baseline and Day 84

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Onset on Treatment Day 1
Tidsramme: Day 1
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.
Day 1
Change From Baseline in Trough FEV1 on Treatment Day 85
Tidsramme: Baseline and Day 85
Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.
Baseline and Day 85

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

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

1. februar 2011

Primær fullføring (Faktiske)

1. oktober 2011

Studiet fullført (Faktiske)

19. oktober 2011

Datoer for studieregistrering

Først innsendt

14. april 2011

Først innsendt som oppfylte QC-kriteriene

26. april 2011

Først lagt ut (Anslag)

27. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 113107

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. Datasett for individuell deltaker
    Informasjonsidentifikator: 113107
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotert saksrapportskjema
    Informasjonsidentifikator: 113107
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informasjonsidentifikator: 113107
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasettspesifikasjon
    Informasjonsidentifikator: 113107
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk studierapport
    Informasjonsidentifikator: 113107
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Skjema for informert samtykke
    Informasjonsidentifikator: 113107
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokoll
    Informasjonsidentifikator: 113107
    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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