A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,811

Participants

Timeline

Start Date

January 23, 2015

Primary Completion Date

April 1, 2016

Study Completion Date

April 7, 2016

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Triple FF/UMEC/VI

The combination will be provided as inhalation via an ELLIPTA DPI having 30 doses (2 strips with 30 blisters per strip). It will have 100 mcg of FF (blended with lactose) per blister, 62.5 mcg of UMEC (blended with lactose and magnesium stearate) per blister and 25 mcg of VI (blended with lactose) per blister.

DRUG

Placebo to match FF/UMEC/VI

The placebo (Lactose) will be provided as inhalation via an ELLIPTA DPI having 30 doses (2 strips with 30 blisters per strip).

DRUG

Budesonide/Formoterol

The combination (400 mcg Budesonide/12 mcg Formoterol) will be provided as inhalation via TURBOHALER with 60 doses.

DRUG

Placebo to match Budesonide/Formoterol combination

The placebo (Lactose) will be provided as inhalation via TURBOHALER with 60 doses.

DRUG

Albuterol/salbutamol

Albuterol/salbutamol will be available as an inhalation via metered-dose inhaler (MDI) with a spacer and will be issued for reversibility testing at Visit 1 Albuterol/salbutamol MDI or NEBULES™ for as needed (prn) use throughout the study will be provided starting at Visit 1.

Trial Locations (159)

1202

GSK Investigational Site, Sofia

1407

GSK Investigational Site, Sofia

1606

GSK Investigational Site, Sofia

2040

GSK Investigational Site, Budaörs

2045

GSK Investigational Site, Törökbálint

2100

GSK Investigational Site, Gödöllő

2660

GSK Investigational Site, Balassagyarmat

3000

GSK Investigational Site, Hatvan

3700

GSK Investigational Site, Vidin

3800

GSK Investigational Site, Szikszó

4002

GSK Investigational Site, Plovdiv

4031

GSK Investigational Site, Debrecen

5500

GSK Investigational Site, Lovech

5800

GSK Investigational Site, Pleven

6400

GSK Investigational Site, Dimitrovgrad

6700

GSK Investigational Site, Mexico City

6722

GSK Investigational Site, Szeged

7000

GSK Investigational Site, Rousse

10117

GSK Investigational Site, Tallinn

10138

GSK Investigational Site, Tallinn

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

12157

GSK Investigational Site, Berlin

13419

GSK Investigational Site, Tallinn

13619

GSK Investigational Site, Tallinn

14080

GSK Investigational Site, México

19055

GSK Investigational Site, Schwerin

20121

GSK Investigational Site, Milan

20354

GSK Investigational Site, Hamburg

21018

GSK Investigational Site, Vinnytsia

21029

GSK Investigational Site, Vinnytsia

21100

GSK Investigational Site, Varese

23552

GSK Investigational Site, Lübeck

30159

GSK Investigational Site, Hanover

31025

GSK Investigational Site, Kohtla-Järve

31238

GSK Investigational Site, Chihuahua City

36024

GSK Investigational Site, Poltava

36038

GSK Investigational Site, Poltava

39112

GSK Investigational Site, Magdeburg

43125

GSK Investigational Site, Parma

44100

GSK Investigational Site, Guadalajara

44500

GSK Investigational Site, Guadalajara

45070

GSK Investigational Site, Zapopan

45200

GSK Investigational Site, Zapopan

46002

GSK Investigational Site, Ternopil

48231

GSK Investigational Site, Warendorf

49074

GSK Investigational Site, Osnabrück

GSK Investigational Site, Dnipropetrovsk

51014

GSK Investigational Site, Tartu

51069

GSK Investigational Site, Cologne

54055

GSK Investigational Site, Tlanepantla

54769

GSK Investigational Site, Cuautitlán Izcalli

56124

GSK Investigational Site, Pisa

56403

GSK Investigational Site, Thessaloniki

56429

GSK Investigational Site, Thessaloniki

57010

GSK Investigational Site, Thessaloniki

58005

GSK Investigational Site, Chernivtsi

60596

GSK Investigational Site, Frankfurt am Main

61035

GSK Investigational Site, Kharkiv

61039

GSK Investigational Site, Kharkiv

61124

GSK Investigational Site, Kharkiv

63263

GSK Investigational Site, Neu-Isenburg

64000

GSK Investigational Site, Monterrey

64020

GSK Investigational Site, Monterrey

64460

GSK Investigational Site, Monterrey

64710

GSK Investigational Site, Monterrey

64718

GSK Investigational Site, Monterrey NL

65187

GSK Investigational Site, Wiesbaden

65500

GSK Investigational Site, Kavala

68000

GSK Investigational Site, Oaxaca City

71110

GSK Investigational Site, Heraklion, Crete

72000

GSK Investigational Site, Puebla, Pue

74100

GSK Investigational Site, Rethymnon, Crete

76018

GSK Investigational Site, Ivano-Frankivsk

80010

GSK Investigational Site, Pärnu

80131

GSK Investigational Site, Napoli

84025

GSK Investigational Site, Eboli (SA)

90146

GSK Investigational Site, Palermo

90502

GSK Investigational Site, Haapsalu

100029

GSK Investigational Site, Beijing

100050

GSK Investigational Site, Beijing

110004

GSK Investigational Site, Shenyang

110015

GSK Investigational Site, Shenyang

110084

GSK Investigational Site, Piteşti

115409

GSK Investigational Site, Moscow

150003

GSK Investigational Site, Yaroslavl

170036

GSK Investigational Site, Tver'

194291

GSK Investigational Site, Saint Petersburg

195030

GSK Investigational Site, Saint Petesburg

196247

GSK Investigational Site, Saint Pertersburg

197706

GSK Investigational Site, Sestroretsk

198216

GSK Investigational Site, Saint Petersburg

198260

GSK Investigational Site, Saint Petersburg

214023

GSK Investigational Site, Wuxi

300310

GSK Investigational Site, Timișoara

355017

GSK Investigational Site, Stavropol

394018

GSK Investigational Site, Voronezh

400037

GSK Investigational Site, Chongqing

400371

GSK Investigational Site, Cluj-Napoca

410028

GSK Investigational Site, Saratov

410053

GSK Investigational Site, Saratov

426063

GSK Investigational Site, Izhevsk

450000

GSK Investigational Site, Ufa

505100

GSK Investigational Site, Codlea

510120

GSK Investigational Site, Guangzhou

570311

GSK Investigational Site, Haikou

620137

GSK Investigational Site, Yekaterinburg

650000

GSK Investigational Site, Kemerovo

650002

GSK Investigational Site, Kemerovo

720284

GSK Investigational Site, Suceava

800189

GSK Investigational Site, Galati

Unknown

GSK Investigational Site, Hangzhou

GSK Investigational Site, Kyiv

680 01

GSK Investigational Site, Boskovice

250 01

GSK Investigational Site, Brandýs nad Labem

471 54

GSK Investigational Site, Cvikov

360 17

GSK Investigational Site, Karlovy Vary

278 01

GSK Investigational Site, Kralupy nad Vltavou

140 46

GSK Investigational Site, Prague

169 00

GSK Investigational Site, Prague

337 01

GSK Investigational Site, Rokycany

390 19

GSK Investigational Site, Tábor

415 10

GSK Investigational Site, Teplice

04910

GSK Investigational Site, Elsterwerda

01069

GSK Investigational Site, Dresden

04109

GSK Investigational Site, Leipzg

106 76

GSK Investigational Site, Athens

115 27

GSK Investigational Site, Athens

124 62

GSK Investigational Site, Athens

151 26

GSK Investigational Site, Athens

07760

GSK Investigational Site, Mexico City

15-003

GSK Investigational Site, Bialystok

15-044

GSK Investigational Site, Bialystok

82-300

GSK Investigational Site, Elblag

86-300

GSK Investigational Site, Grudziądz

27-400

GSK Investigational Site, Ostrowiec Świętokrzyski

96-100

GSK Investigational Site, Skierniewice

76-200

GSK Investigational Site, Słupsk

030303

GSK Investigational Site, Bucharest

050159

GSK Investigational Site, Bucharest

656 045

GSK Investigational Site, Barnaul

123 182

GSK Investigational Site, Moscow

634 050

GSK Investigational Site, Tomsk

972 01

GSK Investigational Site, Bojnice

934 01

GSK Investigational Site, Levice

033 01

GSK Investigational Site, Liptovský Hrádok

058 01

GSK Investigational Site, Poprad

080 01

GSK Investigational Site, Prešov

200-722

GSK Investigational Site, Chuncheon

403-720

GSK Investigational Site, Incheon

561-712

GSK Investigational Site, Jeonju-si, Jeollabuk-Do

100-032

GSK Investigational Site, Seoul

130-709

GSK Investigational Site, Seoul

138-736

GSK Investigational Site, Seoul

03680

GSK Investigational Site, Kiev

GSK Investigational Site, Kyiv

01114

GSK Investigational Site, Kyiv

02091

GSK Investigational Site, Kyiv

03038

GSK Investigational Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02345161 - A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter