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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

528

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Bouge, Belgien, 5004
        • GSK Investigational Site
      • Brussels, Belgien, 1200
        • GSK Investigational Site
      • Bruxelles, Belgien, 1070
        • GSK Investigational Site
      • Edegem, Belgien, 2650
        • GSK Investigational Site
      • Genk, Belgien, 3600
        • GSK Investigational Site
      • Gent, Belgien, 9000
        • GSK Investigational Site
      • Gilly, Belgien, 6060
        • GSK Investigational Site
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation, 454034
        • GSK Investigational Site
      • Kazan, Den Russiske Føderation, 420015
        • GSK Investigational Site
      • Kemerovo, Den Russiske Føderation, 650000
        • GSK Investigational Site
      • Moscow, Den Russiske Føderation, 115446
        • GSK Investigational Site
      • Moscow, Den Russiske Føderation, 125367
        • GSK Investigational Site
      • Moscow, Den Russiske Føderation, 115093
        • GSK Investigational Site
      • Yaroslavl, Den Russiske Føderation, 150003
        • GSK Investigational Site
  • Filippinerne
      • Jaro, Iloilo City, Filippinerne, 5000
        • GSK Investigational Site
      • Lipa City, Filippinerne, 4217
        • GSK Investigational Site
      • Quezon City, Filippinerne, 1101
        • GSK Investigational Site
      • Quezon City, Filippinerne, 1100
        • GSK Investigational Site
  • Frankrig
      • Bethune Cedex, Frankrig, 62408
        • GSK Investigational Site
      • Brest Cedex, Frankrig, 29609
        • GSK Investigational Site
      • Lille, Frankrig, 59000
        • GSK Investigational Site
      • Marseille Cedex 20, Frankrig, 13915
        • GSK Investigational Site
      • Montpellier cedex 5, Frankrig, 34295
        • GSK Investigational Site
      • Nice, Frankrig, 06002
        • GSK Investigational Site
      • Pessac cedex, Frankrig, 33604
        • GSK Investigational Site
  • Italien
    • Campania
      • Benevento, Campania, Italien, 82100
        • GSK Investigational Site
      • Salerno, Campania, Italien, 84100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italien, 00135
        • GSK Investigational Site
    • Lombardia
      • Sesto S. Giovanni MI, Lombardia, Italien, 20099
        • GSK Investigational Site
    • Puglia
      • Acquaviva Delle Fonti BA, Puglia, Italien, 70021
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italien, 56124
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italien, 06156
        • GSK Investigational Site
    • Veneto
      • Cittadella PD, Veneto, Italien, 35013
        • GSK Investigational Site
      • Verona, Veneto, Italien, 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
  • Spanien
      • Alicante, Spanien, 03114
        • GSK Investigational Site
      • Barakaldo (Vizcaya), Spanien, 48903
        • GSK Investigational Site
      • Cáceres, Spanien, 10003
        • GSK Investigational Site
      • Madrid, Spanien, 28040
        • GSK Investigational Site
      • Pozuelo De Alarcón/Madrid, Spanien, 28223
        • GSK Investigational Site
      • San Sebastián, Spanien, 20014
        • GSK Investigational Site
      • Valencia, Spanien, 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
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • GSK Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61035
        • GSK Investigational Site
      • Kiev, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 04107
        • 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:

  • 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

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

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. februar 2011

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

19. oktober 2011

Datoer for studieregistrering

Først indsendt

14. april 2011

Først indsendt, der opfyldte QC-kriterier

26. april 2011

Først opslået (Skøn)

27. april 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 113107

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: 113107
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annoteret sagsbetænkningsformular
    Informations-id: 113107
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informations-id: 113107
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasætspecifikation
    Informations-id: 113107
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk undersøgelsesrapport
    Informations-id: 113107
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formular til informeret samtykke
    Informations-id: 113107
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: 113107
    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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