Completed

Study Description:

This is a phase IIIa, randomised, double-blind, double-dummy, parallel group multicenter study evaluating once daily FF/UMEC/VI (100 microgram [mcg]/62.5 mcg/25 mcg) inhalation powder versus twice daily budesonide/formoterol (400 mcg/12 mcg). The primary purpose of this study is to demonstrate improvements in lung function and health status for subjects treated with FF/UMEC/VI compared with budesonide/formoterol for 24 weeks. Once-daily ‘closed’ triple therapy of a Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) combination FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) in a single device is being developed with the aim of providing a new treatment option for the management of advanced (GOLD Group D) COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and increase the potential for improvement in lung function, Health Related Quality of Life (HRQoL) and symptom control over established dual/monotherapies. Subjects meeting all inclusion/exclusion criteria and who have successfully completed all protocol procedures at the Screening Visit will enter the two-week run-in period. Following the run-in period, eligible subjects will be randomised (1:1) to one of the following double-blind treatment groups: FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg via the ELLIPTA™ dry powder inhaler (DPI) once daily in the morning and placebo via reservoir inhaler twice daily OR Budesonide/formoterol 400 mcg/12 mcg via reservoir inhaler twice daily and placebo via the ELLIPTA DPI once daily in the morning. The target enrollment is 1800 randomised subjects at approximately 200 study centers globally. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period. Subjects will run-in on their existing COPD medications for 2 weeks and in addition will be provided with short acting albuterol/salbutamol to be used on an as-needed basis (rescue medication) throughout the study. Subjects will discontinue all existing COPD medications during the randomised treatment period but may continue their study supplied rescue albuterol/salbutamol. A sub-set of approximately 400 subjects will remain on blinded study treatment for up to a total of 52 weeks to provide additional long term safety data. ELLIPTA and NUBULES are a trade marks of the GlaxoSmithKline Group of Companies. Other company or product names mentioned herein may be the property of their respective owners

GSK Study ID:

116853


ClinicalTrials.gov Identifier:

NCT02345161


Has Results Available Below
EudraCT Number:

2013-003073-10


Study Overview

Medical Conditions

Chronic Obstructive Pulmonary Disease

Product

fluticasone furoate;fluticasone furoate/vilanterol/umeclidinium bromide;umeclidinium bromide;vilanterol

Collaborators

N/A


Date

January 2015 to April 2016

Type

Interventional

Phase

3


Gender

All

Age

40 years - N/A

Accepts Healthy Volunteers

No


This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Bulgaria, Dimitrovgrad 6400Completed
Bulgaria, Lovech 5500Completed
Bulgaria, Pleven 5800Completed
Bulgaria, Plovdiv 4002Completed
Bulgaria, Ruse 7000Completed
Bulgaria, Sofia 1407Completed
Bulgaria, Sofia 1202Completed
Bulgaria, Sofia 1606Completed
Bulgaria, Vidin 3700Completed
China, Beijing 100050Completed
China, Beijing 100029Terminated
China, Chongqing 400037Completed
China, Wuxi 214023Completed
China, Guangdong, Guangzhou 510120Completed
China, Hainan, Haikou 570311Completed
China, Liaoning, Shenyang 110004Completed
China, Liaoning, Shenyang 110015Completed
China, Zhejiang, Hangzhou Completed
Czech Republic, Boskovice 680 01Completed
Czech Republic, Brandys nad Labem 250 01Completed
Czech Republic, Cvikov 471 54Completed
Czech Republic, Karlovy Vary 360 17Completed
Czech Republic, Kralupy nad Vltavou 278 01Completed
Czech Republic, Praha 4 140 46Completed
Czech Republic, Praha 6 169 00Completed
Czech Republic, Rokycany 337 01Completed
Czech Republic, Tabor 390 19Completed
Czech Republic, Teplice 415 10Completed
Estonia, Haapsalu 90502Completed
Estonia, Kohtla-Jarve 31025Completed
Estonia, Parnu 80010Completed
Estonia, Tallinn 13419Completed
Estonia, Tallinn 10138Completed
Estonia, Tallinn 10117Completed
Estonia, Tallinn 13619Completed
Estonia, Tartu 51014Completed
Germany, Berlin, Berlin 12157Completed
Germany, Berlin, Berlin 10717Completed
Germany, Berlin, Berlin 10787Completed
Germany, Brandenburg, Elsterwerda 04910Completed
Germany, Hamburg, Hamburg 20354Completed
Germany, Hessen, Frankfurt 60596Completed
Germany, Hessen, Neu isenburg 63263Completed
Germany, Hessen, Wiesbaden 65187Terminated
Germany, Mecklenburg-Vorpommern, Schwerin 19055Completed
Germany, Niedersachsen, Hannover 30159Completed
Germany, Niedersachsen, Osnabrueck 49074Completed
Germany, Nordrhein-Westfalen, Koeln 51069Completed
Germany, Nordrhein-Westfalen, Warendorf 48231Completed
Germany, Sachsen, Dresden 01069Completed
Germany, Sachsen, Leipzg 04109Completed
Germany, Sachsen-Anhalt, Magdeburg 39112Completed
Germany, Schleswig-Holstein, Luebeck 23552Completed
Greece, Athens 106 76Completed
Greece, Athens 115 27Completed
Greece, Athens 124 62Completed
Greece, Athens 151 26Completed
Greece, Heraklion, Crete 71110Completed
Greece, Kavala 65500Completed
Greece, Rethymnon, Crete 74100Completed
Greece, Thessaloniki 56403Completed
Greece, Thessaloniki 57010Completed
Greece, Thessaloniki 56429Completed
Hungary, Balassagyarmat 2660Completed
Hungary, Budaörs 2040Completed
Hungary, Debrecen 4031Completed
Hungary, Gödöllő 2100Completed
Hungary, Hatvan 3000Completed
Hungary, Szeged 6722Completed
Hungary, Szikszó 3800Completed
Hungary, Törökbálint 2045Completed
Italy, Campania, Eboli (SA) 84025Completed
Italy, Campania, Napoli 80131Completed
Italy, Emilia-Romagna, Parma 43125Completed
Italy, Lombardia, Milano 20121Completed
Italy, Lombardia, Varese 21100Completed
Italy, Sicilia, Palermo 90146Completed
Italy, Toscana, Pisa 56124Completed
Mexico, Mexico 14080Completed
Mexico, Mexico City 07760Completed
Mexico, Mexico D.F 6700Completed
Mexico, Chihuahua, Chihuahua 31238Completed
Mexico, Estado de México, Cuautitlan Izcalli 54769Completed
Mexico, Estado de México, Tlanepantla 54055Completed
Mexico, Jalisco, Guadalajara 44500Completed
Mexico, Jalisco, Guadalajara 44100Completed
Mexico, Jalisco, Zapopan 45070Completed
Mexico, Jalisco, Zapopan 45200Completed
Mexico, Nuevo León, Monterrey 64710Completed
Mexico, Nuevo León, Monterrey 64000Completed
Mexico, Nuevo León, Monterrey 64020Completed
Mexico, Nuevo León, Monterrey 64460Completed
Mexico, Nuevo León, Monterrey NL 64718Completed
Mexico, Oaxaca, Oaxaca 68000Completed
Mexico, Puebla, Puebla, Pue 72000Completed
Poland, Bialystok 15-044Completed
Poland, Bialystok 15-003Terminated
Poland, Elblag 82-300Completed
Poland, Grudziadz 86-300Completed
Poland, Ostrowiec Swietokrzyski 27-400Completed
Poland, Skierniewice 96-100Completed
Poland, Slupsk 76-200Completed
Romania, Bucharest 030303Completed
Romania, Bucharest 050159Completed
Romania, Cluj-Napoca 400371Completed
Romania, Codlea 505100Completed
Romania, Galati 800189Completed
Romania, Pitesti 110084Completed
Romania, Suceava 720284Completed
Romania, Timisoara 300310Completed
Romania, cluj napoca 400371Completed
Russia, Barnaul 656 045Completed
Russia, Ekaterinburg 620137Completed
Russia, Izhevsk 426063Completed
Russia, Kemerovo 650000Completed
Russia, Kemerovo 650002Completed
Russia, Moscow 115409Completed
Russia, Moscow 123 182Completed
Russia, Saint Petesburg 195030Completed
Russia, Saint-Petersburg 198260Completed
Russia, Saratov 410028Completed
Russia, Saratov 410053Completed
Russia, Sestroretsk 197706Completed
Russia, St Pertersburg 196247Completed
Russia, St. Petersburg 198216Completed
Russia, St. Petersburg 194291Completed
Russia, Stavropol 355017Completed
Russia, Tomsk 634 050Completed
Russia, Tver 170036Completed
Russia, Ufa 450000Completed
Russia, Voronezh 394018Completed
Russia, Yaroslavl 150003Completed
Slovakia, Bojnice 972 01Completed
Slovakia, Levice 934 01Completed
Slovakia, Liptovsky Hradok 033 01Completed
Slovakia, Poprad 058 01Completed
Slovakia, Presov 080 01Completed
South Korea, Chuncheon 200-722Completed
South Korea, Incheon 403-720Completed
South Korea, Seoul 100-032Completed
South Korea, Seoul 130-709Completed
South Korea, Seoul 138-736Completed
South Korea, jeonju-si, Jeollabuk-Do 561-712Completed
Ukraine, Chernivtsi 58005Completed
Ukraine, Dnipropetrovsk 49074Completed
Ukraine, Ivano-Frankivsk 76018Completed
Ukraine, Kharkiv 61035Completed
Ukraine, Kharkiv 61039Completed
Ukraine, Kharkiv 61124Completed
Ukraine, Kiev 03680Completed
Ukraine, Kyiv Completed
Ukraine, Kyiv 01114Completed
Ukraine, Kyiv 02091Completed
Ukraine, Kyiv 03038Completed
Ukraine, Kyiv 03680Completed
Ukraine, Poltava 36024Completed
Ukraine, Poltava 36038Completed
Ukraine, Ternopil 46002Terminated
Ukraine, Vinnytsia 21018Completed
Ukraine, Vinnytsia 21029Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: No
  • Masked Investigator: Yes
  • Masked Assessor: No
Primary Outcomes:

  • Change from Baseline in trough forced expiratory volume in one second (FEV1) at Week 24
    Timeframe: Baseline to Week 24

  • Change from Baseline in trough forced expiratory volume in one second (FEV1) at Week 52
    Timeframe: Baseline to Week 52

  • Change from Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD participants at Week 24
    Timeframe: Baseline to Week 24

  • Change from Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD participants at Week 52
    Timeframe: Baseline to Week 52

Secondary Outcomes:

  • Transitional Dyspnea Index (TDI) focal score expressed as least square mean at Week 24
    Timeframe: Week 24

  • Transitional Dyspnea Index (TDI) focal score expressed as least square mean at Week 52
    Timeframe: Week 52

  • Daily activity question percentage of days reporting a score of 2 up to Week 24
    Timeframe: Up to Week 24

  • Daily activity question percentage of days reporting a score of 2 up to Week 52
    Timeframe: Up to Week 52

  • Mean annual on-treatment moderate and/or severe COPD exacerbations up to Week 24
    Timeframe: Up to Week 24

  • Mean annual on-treatment moderate and/or severe COPD exacerbations up to Week 52
    Timeframe: Up to Week 52

  • Assessment of respiratory symptoms by change from Baseline in 4-weekly mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS scores up to Week 24
    Timeframe: Baseline to Week 24

  • Assessment of respiratory symptoms by change from Baseline in 4-weekly mean EXACT-RS scores up to Week 52
    Timeframe: Baseline to Week 52

  • Number of participants with any on-treatment adverse event (AE) and serious adverse event (SAE) in the treatment period
    Timeframe: Up to Week 24

  • Number of participants with any on-treatment AE/SAEs in the extension part of the study
    Timeframe: Up to Week 52

  • Number of participants with an on-treatment penumonia event in the treatment period
    Timeframe: Up to Week 24

  • Number of participants with an on-treatment penumonia event in the extension part of the study
    Timeframe: Up to Week 52

  • Number of participants with any on-treatment cardiovascular (CV) events (including supraventricular arrhythmia and non fatal myocardial infarction) in the treatment period
    Timeframe: Up to Week 24

  • Number of participants with any on-treatment CV events (including supraventricular arrhythmia and non fatal myocardial infarction) in the extension part of the study
    Timeframe: Up to Week 52

  • Change from Baseline in heart rate at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in heart rate at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in Corrected QT Interval using Fridericia’s Correction (QTcF) and PR interval at Week 24
    Timeframe: Baseline and Week 24

  • Change from baseline in QTcF and PR interval at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Week 24
    Timeframe: Baseline and Week 24

  • Change from baseline in QTcB at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in systolic and diastolic blood pressures (BP) at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in systolic and diastolic blood pressures (BP) at Week 52
    Timeframe: Baseline and Week 52

  • Number of participants with any abnormal holter electrocardiogram (ECG) finding at Week 24
    Timeframe: Up to Week 24

  • Change from Baseline in pulse rate at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in pulse rate at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in basophils, eosinophils, monocytes, neutrophils, leukocytes, lymphocytes, and platelets at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in basophils, eosinophils, monocytes, neutrophils, leukocytes, lymphocytes, and platelets at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in erythrocytes at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in erythrocytes at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in hemoglobin at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in hemoglobin at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in hematocrit at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in hematocrit at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in albumin and protein at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in albumin and protein at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl aminotransferase (GGT), alkaline phosphatase (ALP), and creatine kinase at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in ALT, AST, GGT, ALP, and creatine kinase at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in glucose, calcium, carbon dioxide (CO2), chloride, phosphate, potassium, sodium, and urea at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in glucose, calcium, CO2, chloride, magnesium, phosphate, potassium, sodium, and urea at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in bilirubin, creatinine, and urate at Week 24
    Timeframe: Baseline and Week 24

  • Change from Baseline in bilirubin, creatinine, and urate at Week 52
    Timeframe: Baseline and Week 52

  • Number of participants reporting an adverse event of special interest (AESI) of oropharyngeal origin in the treatment period
    Timeframe: Up to Week 24

  • Number of participants reporting an AESI of oropharyngeal origin in the extension part of the study
    Timeframe: Up to Week 52

  • Number of participants with at least one on-treatment bone fracture incident in the treatment period
    Timeframe: Up to Week 24

  • Number of participants with at least one on-treatment bone fracture incident in the extension part of the study
    Timeframe: Up to Week 52

Arms:
  • 2

Interventions:

  • Drug: Triple FF/UMEC/VI
  • Drug: Placebo to match FF/UMEC/VI
  • Drug: Budesonide/Formoterol
  • Drug: Placebo to match Budesonide/Formoterol combination
  • Drug: Albuterol/salbutamol

Keyword:

  • Triple Therapy, Formoterol, Respiratory, COPD, Budesonide, Vilanterol, Fluticasone Furoate, Umeclidinium, Lung Function
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 1811

Clinical Publications:

  • David A. Lipson, Helen Barnacle, Ruby Birk, Noushin Brealey, Nicholas Locantore, David A. Lomas, Andrea Ludwig Sengpiel, Rajat Mohindra, Maggie Tabberer, Chang-Qing Zhu, and Steven J. Pascoe. FULFIL Trial: Once-Daily Triple Therapy in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017;194(4):436-446