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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 augusti 2018 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

528

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Filippinerna
      • Jaro, Iloilo City, Filippinerna, 5000
        • GSK Investigational Site
      • Lipa City, Filippinerna, 4217
        • GSK Investigational Site
      • Quezon City, Filippinerna, 1101
        • GSK Investigational Site
      • Quezon City, Filippinerna, 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
  • 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
  • Ryska Federationen
      • Chelyabinsk, Ryska Federationen, 454034
        • GSK Investigational Site
      • Kazan, Ryska Federationen, 420015
        • GSK Investigational Site
      • Kemerovo, Ryska Federationen, 650000
        • GSK Investigational Site
      • Moscow, Ryska Federationen, 115446
        • GSK Investigational Site
      • Moscow, Ryska Federationen, 125367
        • GSK Investigational Site
      • Moscow, Ryska Federationen, 115093
        • GSK Investigational Site
      • Yaroslavl, Ryska Federationen, 150003
        • 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
  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Fluticasone Furoate/Vilanterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
Läkemedel: Fluticasone Furoate 100mcg/Vilanterol 25mcg
Inhalation Powder
Aktiv komparator: Fluticasone Propionate/Salmeterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
Läkemedel: Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Inhalation Powder

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Onset on Treatment Day 1
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2011

Primärt slutförande (Faktisk)

1 oktober 2011

Avslutad studie (Faktisk)

19 oktober 2011

Studieregistreringsdatum

Först inskickad

14 april 2011

Först inskickad som uppfyllde QC-kriterierna

26 april 2011

Första postat (Uppskatta)

27 april 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 113107

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokument

  1. Datauppsättning för individuella deltagare
    Informationsidentifierare: 113107
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annoterad fallrapportformulär
    Informationsidentifierare: 113107
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analysplan
    Informationsidentifierare: 113107
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datauppsättningsspecifikation
    Informationsidentifierare: 113107
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk studierapport
    Informationsidentifierare: 113107
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informerat samtycke
    Informationsidentifierare: 113107
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokoll
    Informationsidentifierare: 113107
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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