A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE4CompletedINTERVENTIONAL
Enrollment

2,696

Participants

Timeline

Start Date

June 16, 2017

Primary Completion Date

June 18, 2018

Study Completion Date

June 18, 2018

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

UMEC/VI 62.5/25 mcg via ELLIPTA

ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; the first strip contains umeclidinium bromide (62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate and second strip contains vilanterol trifenatae (25 mcg per blister) blended with lactose monohydrate and magnesium stearate.

DRUG

UMEC 62.5 mcg via ELLIPTA

The ELLIPTA inhaler will contain one blister strip, which will have 30 blisters of umeclidinium bromide (62.5 mcg).

DRUG

Salmeterol 50 mcg via DISKUS

The DISKUS inhaler will contain one blister strip, which will have 60 blisters of salmeterol xinafoate (50 mcg). The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

DRUG

Placebo via ELLIPTA

Lactose dry powder will be administered using ELLIPTA for both treatment periods. ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; containing lactose dry powder.

DRUG

Placebo via DISKUS

Lactose dry powder will be administered using DISKUS for both treatment periods. The DISKUS inhaler will contain one blister strip, which will have 60 blisters of lactose dry powder. The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.

Trial Locations (212)

1050

GSK Investigational Site, Middelburg

1459

GSK Investigational Site, Reiger Park

1602

GSK Investigational Site, Florida

1842

GSK Investigational Site, Monte Grande

2000

GSK Investigational Site, Rosario

2010

GSK Investigational Site, Darlinghurst, Sydney

GSK Investigational Site, Sydney

2113

GSK Investigational Site, Johannesburg

2259

GSK Investigational Site, Kanwal

2444

GSK Investigational Site, Port Macquarie

2450

GSK Investigational Site, Coffs Harbour

3000

GSK Investigational Site, Santa Fe

3260

GSK Investigational Site, Concepción del Uruguay

4000

GSK Investigational Site, San Miguel de Tucumán

4001

GSK Investigational Site, Durban

5500

GSK Investigational Site, Mendoza

5501

GSK Investigational Site, Mendoza

5600

GSK Investigational Site, San Rafael

6300

GSK Investigational Site, Santa Rosa

7240

GSK Investigational Site, Lobos

7500

GSK Investigational Site, Panorama

7570

GSK Investigational Site, Cape Town

7600

GSK Investigational Site, Mar del Plata

7700

GSK Investigational Site, Mowbray

9301

GSK Investigational Site, Bloemfontein

10117

GSK Investigational Site, Berlin

10119

GSK Investigational Site, Berlin

10367

GSK Investigational Site, Berlin

10625

GSK Investigational Site, Berlin

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

11446

GSK Investigational Site, Stockholm

12627

GSK Investigational Site, Berlin

13086

GSK Investigational Site, Berlin

13156

GSK Investigational Site, Berlin

13331

GSK Investigational Site, Marseille

14059

GSK Investigational Site, Berlin

14469

GSK Investigational Site, Potsdam

15562

GSK Investigational Site, Rüdersdorf

17005

GSK Investigational Site, Girona

17491

GSK Investigational Site, Peralada( Girona)

19055

GSK Investigational Site, Schwerin

20253

GSK Investigational Site, Hamburg

21049

GSK Investigational Site, Tradate (VA)

21502

GSK Investigational Site, Geesthacht

22143

GSK Investigational Site, Hamburg

22299

GSK Investigational Site, Hamburg

23552

GSK Investigational Site, Lübeck

24210

GSK Investigational Site, Abingdon

24837

GSK Investigational Site, Schleswig

26203

GSK Investigational Site, Wardenburg

26505

GSK Investigational Site, Morgantown

27103

GSK Investigational Site, Winston-Salem

28054

GSK Investigational Site, Gastonia

28112

GSK Investigational Site, Monroe

28117

GSK Investigational Site, Mooresville

28207

GSK Investigational Site, Charlotte

29303

GSK Investigational Site, Spartanburg

29340

GSK Investigational Site, Gaffney

29379

GSK Investigational Site, Union

29464

GSK Investigational Site, Mt. Pleasant

29603

GSK Investigational Site, Marbella - Málaga

29615

GSK Investigational Site, Greenville

29621

GSK Investigational Site, Anderson

29640

GSK Investigational Site, Easley

29678

GSK Investigational Site, Seneca

29720

GSK Investigational Site, Lancaster

29732

GSK Investigational Site, Rock Hill

30159

GSK Investigational Site, Hanover

30167

GSK Investigational Site, Hanover

30173

GSK Investigational Site, Hanover

31224

GSK Investigational Site, Peine

32825

GSK Investigational Site, Orlando

33170

GSK Investigational Site, Pordenone

33603

GSK Investigational Site, Tampa

33604

GSK Investigational Site, Pessac

33765

GSK Investigational Site, Clearwater

34121

GSK Investigational Site, Kassel

35037

GSK Investigational Site, Marburg

36039

GSK Investigational Site, Fulda

42100

GSK Investigational Site, Reggio Emilia

44100

GSK Investigational Site, Guadalajara

44263

GSK Investigational Site, Dortmund

44787

GSK Investigational Site, Bochum

45070

GSK Investigational Site, Zapopan

45231

GSK Investigational Site, Cincinnati

45355

GSK Investigational Site, Essen

45359

GSK Investigational Site, Essen

45879

GSK Investigational Site, Gelsenkirchen

47838

GSK Investigational Site, Riccione (RN)

48231

GSK Investigational Site, Warendorf

48431

GSK Investigational Site, Rheine

49074

GSK Investigational Site, Osnabrück

51069

GSK Investigational Site, Cologne

51429

GSK Investigational Site, Bergisch Gladbach

52349

GSK Investigational Site, Düren

53119

GSK Investigational Site, Bonn

53123

GSK Investigational Site, Bonn

55125

GSK Investigational Site, Woodbury

55407

GSK Investigational Site, Minneapolis

55432

GSK Investigational Site, Fridley

55435

GSK Investigational Site, Edina

56068

GSK Investigational Site, Koblenz

56124

GSK Investigational Site, Pisa

60313

GSK Investigational Site, Frankfurt

60389

GSK Investigational Site, Frankfurt am Main

60596

GSK Investigational Site, Frankfurt am Main

62269

GSK Investigational Site, O'Fallon

63017

GSK Investigational Site, Chesterfield

63141

GSK Investigational Site, St Louis

63263

GSK Investigational Site, Neu-Isenburg

63301

GSK Investigational Site, Saint Charles

64283

GSK Investigational Site, Darmstadt

66000

GSK Investigational Site, Perpignan

68134

GSK Investigational Site, Omaha

69168

GSK Investigational Site, Wiesloch

70020

GSK Investigational Site, Cassano Delle Murge (BA)

71457

GSK Investigational Site, Natchitoches

72027

GSK Investigational Site, San Pietro Vernotico

75092

GSK Investigational Site, Sherman

76137

GSK Investigational Site, Karlsruhe

80131

GSK Investigational Site, Napoli

GSK Investigational Site, Napoli

80339

GSK Investigational Site, Munich

81027

GSK Investigational Site, San Felice A Cancello (CE)

81241

GSK Investigational Site, Munich

82100

GSK Investigational Site, Benevento

84131

GSK Investigational Site, Salerno

85018

GSK Investigational Site, Phoenix

87108

GSK Investigational Site, Albuquerque

90146

GSK Investigational Site, Palermo

91052

GSK Investigational Site, Erlangen

95648

GSK Investigational Site, Lincoln

96049

GSK Investigational Site, Bamberg

97504

GSK Investigational Site, Medford

29406-7108

GSK Investigational Site, Charleston

C1028AAP

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

C1414AIF

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

C1425AGC

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

Unknown

GSK Investigational Site, La Plata

B7600FZN

GSK Investigational Site, Mar del Plata

E3100BHK

GSK Investigational Site, Paraná

B1878FNR

GSK Investigational Site, Quilmes

B1602DOH

GSK Investigational Site, Vicente López

X5003DCE

GSK Investigational Site, Córdoba

S2002OJN

GSK Investigational Site, Rosario

C1120AAC

GSK Investigational Site, Buenos Aires

C1121ABE

GSK Investigational Site, Buenos Aires

C1128AAF

GSK Investigational Site, Buenos Aires

C1424BSF

GSK Investigational Site, Buenos Aires

C1425BEN

GSK Investigational Site, Buenos Aires

C1426ABP

GSK Investigational Site, Buenos Aires

C1440BRR

GSK Investigational Site, Capital Federal

C1015ABR

GSK Investigational Site, Ciudad Autonoma de Buenis Aires

M5500CCG

GSK Investigational Site, Mendoza

T4000DGF

GSK Investigational Site, San Miguel de Tucumán

E1G1A7

GSK Investigational Site, Moncton

B2N 1L2

GSK Investigational Site, Truro

L8L 5G8

GSK Investigational Site, Hamilton

N5W 6A2

GSK Investigational Site, London

N7T 4X3

GSK Investigational Site, Sarnia

M9V 4B4

GSK Investigational Site, Toronto

N8X 1T3

GSK Investigational Site, Windsor

J8Y 6S8

GSK Investigational Site, Gatineau

J7J 2K8

GSK Investigational Site, Mirabel

H1M 1B1

GSK Investigational Site, Montreal

G1V 4G5

GSK Investigational Site, Québec

G1W 4R4

GSK Investigational Site, Québec

J6E 2B4

GSK Investigational Site, Saint-Charles-Borromée

06000

GSK Investigational Site, Nice

09456

GSK Investigational Site, Annaberg

04509

GSK Investigational Site, Delitzsch

01069

GSK Investigational Site, Dresden

04109

GSK Investigational Site, Leipzg

04103

GSK Investigational Site, Leipzig

04157

GSK Investigational Site, Leipzig

04275

GSK Investigational Site, Leipzig

04357

GSK Investigational Site, Leipzig

09648

GSK Investigational Site, Mittweida

06682

GSK Investigational Site, Teuchern

04626

GSK Investigational Site, Schmölln

04207

GSK Investigational Site, Leipzig

06156

GSK Investigational Site, San Sisto (PG)

1311 RL

GSK Investigational Site, Almere Stad

6191 JW

GSK Investigational Site, Beek

4818 CK

GSK Investigational Site, Breda

6419 PC

GSK Investigational Site, Heerlen

1624 NP

GSK Investigational Site, Hoorn

7694 AC

GSK Investigational Site, Kloosterhaar

3067 GJ

GSK Investigational Site, Rotterdam

2565 KV

GSK Investigational Site, The Hague

7207 AE

GSK Investigational Site, Zutphen

0084

GSK Investigational Site, Eloffsdal

0087

GSK Investigational Site, Pretoria

0121

GSK Investigational Site, Pretoria

03004

GSK Investigational Site, Alicante

08023

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

08540

GSK Investigational Site, Centelles (Barcelona)

06800

GSK Investigational Site, Mérida (Badajoz)

SE-506 30

GSK Investigational Site, Borås

SE-413 45

GSK Investigational Site, Gothenburg

SE-413 90

GSK Investigational Site, Gothenburg

SE-236 51

GSK Investigational Site, Höllviken

SE-587 58

GSK Investigational Site, Linköping

SE-971 89

GSK Investigational Site, Luleå

SE-221 85

GSK Investigational Site, Lund

SE-222 22

GSK Investigational Site, Lund

SE-211 52

GSK Investigational Site, Malmo

SE-703 62

GSK Investigational Site, Örebro

SE-541 50

GSK Investigational Site, Skövde

SE-752 37

GSK Investigational Site, Uppsala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03034915 - A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter