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))
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)
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Studietype
Inschrijving (Werkelijk)
Inschrijving
Fase
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Bouge, België, 5004
- GSK Investigational Site
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Brussels, België, 1200
- GSK Investigational Site
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Bruxelles, België, 1070
- GSK Investigational Site
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Edegem, België, 2650
- GSK Investigational Site
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Genk, België, 3600
- GSK Investigational Site
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Gent, België, 9000
- GSK Investigational Site
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Gilly, België, 6060
- GSK Investigational Site
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Berlin, Duitsland, 14057
- GSK Investigational Site
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Berlin, Duitsland, 10117
- GSK Investigational Site
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Berlin, Duitsland, 10787
- GSK Investigational Site
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Berlin, Duitsland, 10789
- GSK Investigational Site
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Hamburg, Duitsland, 20253
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, Duitsland, 80809
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, Duitsland, 60389
- GSK Investigational Site
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Frankfurt am Main, Hessen, Duitsland, 60596
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Duitsland, 30159
- GSK Investigational Site
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Sachsen
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Delitzsch, Sachsen, Duitsland, 04509
- GSK Investigational Site
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Dresden, Sachsen, Duitsland, 01307
- GSK Investigational Site
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Leipzig, Sachsen, Duitsland, 04207
- GSK Investigational Site
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Duitsland, 39112
- GSK Investigational Site
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Jaro, Iloilo City, Filippijnen, 5000
- GSK Investigational Site
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Lipa City, Filippijnen, 4217
- GSK Investigational Site
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Quezon City, Filippijnen, 1101
- GSK Investigational Site
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Quezon City, Filippijnen, 1100
- GSK Investigational Site
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Bethune Cedex, Frankrijk, 62408
- GSK Investigational Site
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Brest Cedex, Frankrijk, 29609
- GSK Investigational Site
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Lille, Frankrijk, 59000
- GSK Investigational Site
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Marseille Cedex 20, Frankrijk, 13915
- GSK Investigational Site
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Montpellier cedex 5, Frankrijk, 34295
- GSK Investigational Site
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Nice, Frankrijk, 06002
- GSK Investigational Site
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Pessac cedex, Frankrijk, 33604
- GSK Investigational Site
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Campania
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Benevento, Campania, Italië, 82100
- GSK Investigational Site
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Salerno, Campania, Italië, 84100
- GSK Investigational Site
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Lazio
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Roma, Lazio, Italië, 00135
- GSK Investigational Site
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Lombardia
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Sesto S. Giovanni MI, Lombardia, Italië, 20099
- GSK Investigational Site
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Puglia
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Acquaviva Delle Fonti BA, Puglia, Italië, 70021
- GSK Investigational Site
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Toscana
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Pisa, Toscana, Italië, 56124
- GSK Investigational Site
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Umbria
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Perugia, Umbria, Italië, 06156
- GSK Investigational Site
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Veneto
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Cittadella PD, Veneto, Italië, 35013
- GSK Investigational Site
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Verona, Veneto, Italië, 37134
- GSK Investigational Site
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Cherkassy, Oekraïne, 18009
- GSK Investigational Site
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Ivano-Frankivsk, Oekraïne, 76018
- GSK Investigational Site
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Kharkiv, Oekraïne, 61035
- GSK Investigational Site
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Kiev, Oekraïne, 03680
- GSK Investigational Site
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Kyiv, Oekraïne, 04107
- GSK Investigational Site
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Bialystok, Polen
- GSK Investigational Site
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Czestochowa, Polen, 42-200
- GSK Investigational Site
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Lodz, Polen, 93-329
- GSK Investigational Site
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Lodz, Polen, 92-107
- GSK Investigational Site
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Ostrow Wielkopolski, Polen, 63-400
- GSK Investigational Site
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Piekary Slaskie, Polen, 41-940
- GSK Investigational Site
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Wilkowice, Polen, 43-365
- GSK Investigational Site
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Chelyabinsk, Russische Federatie, 454034
- GSK Investigational Site
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Kazan, Russische Federatie, 420015
- GSK Investigational Site
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Kemerovo, Russische Federatie, 650000
- GSK Investigational Site
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Moscow, Russische Federatie, 115446
- GSK Investigational Site
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Moscow, Russische Federatie, 125367
- GSK Investigational Site
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Moscow, Russische Federatie, 115093
- GSK Investigational Site
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Yaroslavl, Russische Federatie, 150003
- GSK Investigational Site
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Alicante, Spanje, 03114
- GSK Investigational Site
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Barakaldo (Vizcaya), Spanje, 48903
- GSK Investigational Site
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Cáceres, Spanje, 10003
- GSK Investigational Site
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Madrid, Spanje, 28040
- GSK Investigational Site
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Pozuelo De Alarcón/Madrid, Spanje, 28223
- GSK Investigational Site
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San Sebastián, Spanje, 20014
- GSK Investigational Site
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Valencia, Spanje, 46015
- GSK Investigational Site
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Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
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Experimenteel: Fluticasone Furoate/Vilanterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
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Inhalation Powder
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Actieve vergelijker: Fluticasone Propionate/Salmeterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
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Inhalation Powder
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Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
Tijdsspanne: Baseline and Day 84
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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.
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Baseline and Day 84
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Secundaire uitkomstmaten
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to Onset on Treatment Day 1
Tijdsspanne: Day 1
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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.
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Day 1
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Change From Baseline in Trough FEV1 on Treatment Day 85
Tijdsspanne: Baseline and Day 85
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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.
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Baseline and Day 85
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Medewerkers en onderzoekers
Sponsor
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studie start
Primaire voltooiing (Werkelijk)
Primaire voltooiing
Studie voltooiing (Werkelijk)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Eerst geplaatst
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update geplaatst
Laatste update ingediend die voldeed aan QC-criteria
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekten van de luchtwegen
- Ademhalingsstoornissen
- Longziekten, obstructief
- Longziekten
- Longziekte, chronisch obstructief
- Ademhaling Aspiratie
- Fysiologische effecten van medicijnen
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Ontstekingsremmende middelen
- Adrenerge agonisten
- Dermatologische middelen
- Bronchusverwijdende middelen
- Anti-astmatische middelen
- Agenten van het ademhalingssysteem
- Anti-allergische middelen
- Adrenerge bèta-2-receptoragonisten
- Adrenerge beta-agonisten
- Fluticason
- Xhance
- Salmeterol Xinafoaat
Andere studie-ID-nummers
Andere studie-ID-nummers
- 113107
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Bestudeer gegevens/documenten
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Gegevensset individuele deelnemers
Informatie-ID: 113107Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Geannoteerd casusrapportformulier
Informatie-ID: 113107Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisch analyseplan
Informatie-ID: 113107Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Specificatie gegevensset
Informatie-ID: 113107Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: 113107Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Formulier geïnformeerde toestemming
Informatie-ID: 113107Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Leerprotocool
Informatie-ID: 113107Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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