A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

2,436

Participants

Timeline

Start Date

October 13, 2016

Primary Completion Date

February 22, 2019

Study Completion Date

February 22, 2019

Conditions
Asthma
Interventions
DRUG

FF/UMEC/VI (100/31.25/25) mcg

Dry white powder delivered via the ELLIPTA DPI (one inhalation once-daily \[QD\] in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.

DRUG

FF/UMEC/VI (100/62.5/25) mcg

Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.

DRUG

FF/UMEC/VI (200/31.25/25) mcg

Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.

DRUG

FF/UMEC/VI (200/62.5/25) mcg

Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.

DRUG

FF/VI (100/25) mcg

Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains VI 25 mcg in each blister.

DRUG

FF/VI (200/25) mcg

Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains VI 25 mcg in each blister.

DRUG

Fluticasone/salmeterol (FSC)

Dry white powder delivered via the DISKUS DPI (one inhalation twice daily: one in the morning and one in the evening). The DISKUS DPI holds a strip of 60 blisters; each blister contains FP 250 mcg and 50 mcg of salmeterol.

DRUG

Albuterol/salbutamol

This is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.

DEVICE

ELLIPTA DPI

The ELLIPTA device will be used during the stabilization period and the treatment period. The ELLIPTA DPI is a moulded plastic two-sided device that can hold two individual blister strips which contain powder formulation for oral inhalation.

DEVICE

DISKUS DPI

The DISKUS device will be used during the run-in period. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FSC for oral inhalation.

DEVICE

METERED-DOSE INHALER (MDI)

Albuterol/salbutamol (rescue medication) will be delivered via metered-dose inhaler (MDI) will be used for reversibility testing.

Trial Locations (409)

1055

GSK Investigational Site, Middelburg

1459

GSK Investigational Site, Reiger Park

1602

GSK Investigational Site, Florida

1884

GSK Investigational Site, Berazategui

2000

GSK Investigational Site, Rosario

2031

GSK Investigational Site, Randwick

2145

GSK Investigational Site, Westmead

2450

GSK Investigational Site, Coffs Harbour

3000

GSK Investigational Site, Santa Fe

3004

GSK Investigational Site, Melbourne

3169

GSK Investigational Site, Clayton

4000

GSK Investigational Site, San Miguel de Tucumán

4001

GSK Investigational Site, Durban

4075

GSK Investigational Site, Sherwood

4551

GSK Investigational Site, Golden Beach

5000

GSK Investigational Site, Córdoba

5042

GSK Investigational Site, Bedford Park

5500

GSK Investigational Site, Mendoza

5600

GSK Investigational Site, San Rafael

6150

GSK Investigational Site, Murdoch

7130

GSK Investigational Site, Somerset West

7500

GSK Investigational Site, Panorama

GSK Investigational Site, Tygerberg

7530

GSK Investigational Site, Bellville

7600

GSK Investigational Site, Mar del Plata

7700

GSK Investigational Site, Mowbray

7764

GSK Investigational Site, Cape Town

8540

GSK Investigational Site, Centelles

9301

GSK Investigational Site, Bloemfontein

10016

GSK Investigational Site, New York

10043

GSK Investigational Site, Orbassano (TO)

10367

GSK Investigational Site, Berlin

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

12203

GSK Investigational Site, Berlin

13156

GSK Investigational Site, Berlin

15025

GSK Investigational Site, Jefferson Hills

15241

GSK Investigational Site, Pittsburgh

15706

GSK Investigational Site, Santiago de Compostela

17005

GSK Investigational Site, Girona

18300

GSK Investigational Site, Loja/ Granada

20162

GSK Investigational Site, Milan

20815

GSK Investigational Site, Chevy Chase

21044

GSK Investigational Site, Columbia

21049

GSK Investigational Site, Tradate (VA)

21236

GSK Investigational Site, Baltimore

21502

GSK Investigational Site, Geesthacht

22299

GSK Investigational Site, Hamburg

23188

GSK Investigational Site, Williamsburg

23225

GSK Investigational Site, Richmond

23552

GSK Investigational Site, Lübeck

24210

GSK Investigational Site, Abingdon

24837

GSK Investigational Site, Schleswig

27100

GSK Investigational Site, Pavia

27104

GSK Investigational Site, Winston-Salem

27262

GSK Investigational Site, High Point

27607

GSK Investigational Site, Raleigh

28054

GSK Investigational Site, Gastonia

28078

GSK Investigational Site, Huntersville

28100

GSK Investigational Site, Alcobendas

28150

GSK Investigational Site, Shelby

28223

GSK Investigational Site, Pozuelo de Alarcón/Madrid

28277

GSK Investigational Site, Charlotte

28401

GSK Investigational Site, Wilmington

28644

GSK Investigational Site, Cheongju-si, Chungcheongbuk-do

28801

GSK Investigational Site, Asheville

29118

GSK Investigational Site, Orangeburg

29301

GSK Investigational Site, Spartanburg

29303

GSK Investigational Site, Spartanburg

29414

GSK Investigational Site, Charleston

29615

GSK Investigational Site, Greenville

29621

GSK Investigational Site, Anderson

30103

GSK Investigational Site, Adairsville

31904

GSK Investigational Site, Columbus

32308

GSK Investigational Site, Tallahassee

33024

GSK Investigational Site, Hollywood

33173

GSK Investigational Site, Miami

33180

GSK Investigational Site, Aventura

33458

GSK Investigational Site, Jupiter

33511

GSK Investigational Site, Brandon

33709

GSK Investigational Site, St. Petersburg

34761

GSK Investigational Site, Ocoee

35012

GSK Investigational Site, Las Palmas

35243

GSK Investigational Site, Birmingham

35365

GSK Investigational Site, Daejeon

36106

GSK Investigational Site, Montgomery

36608

GSK Investigational Site, Mobile

37007

GSK Investigational Site, Salamanca

37075

GSK Investigational Site, Hendersonville

39008

GSK Investigational Site, Santander

40215

GSK Investigational Site, Louisville

41944

GSK Investigational Site, Daegu

42301

GSK Investigational Site, Owensboro

43016

GSK Investigational Site, Dublin

43125

GSK Investigational Site, Parma

44718

GSK Investigational Site, Canton

45231

GSK Investigational Site, Cincinnati

45242

GSK Investigational Site, Cincinnati

45419

GSK Investigational Site, Dayton

45879

GSK Investigational Site, Gelsenkirchen

46360

GSK Investigational Site, Michigan City

46617

GSK Investigational Site, South Bend

47012

GSK Investigational Site, Valladolid

48307

GSK Investigational Site, Rochester

48431

GSK Investigational Site, Rheine

50009

GSK Investigational Site, Zaragoza

55402

GSK Investigational Site, Minneapolis

56068

GSK Investigational Site, Koblenz

56124

GSK Investigational Site, Pisa

60305

GSK Investigational Site, River Forest

60389

GSK Investigational Site, Frankfurt am Main

60596

GSK Investigational Site, Frankfurt am Main

61469

GSK Investigational Site, Gwangju

61761

GSK Investigational Site, Normal

62012

GSK Investigational Site, Civitanova Marche (MC)

63263

GSK Investigational Site, Neu-Isenburg

63301

GSK Investigational Site, Saint Charles

64283

GSK Investigational Site, Darmstadt

66606

GSK Investigational Site, Topeka

68505

GSK Investigational Site, Lincoln

70124

GSK Investigational Site, Bari

70584

GSK Investigational Site, Sunset

72205

GSK Investigational Site, Little Rock

73120

GSK Investigational Site, Oklahoma City

75069

GSK Investigational Site, McKinney

75093

GSK Investigational Site, Plano

75225

GSK Investigational Site, Dallas

75246

GSK Investigational Site, Dallas

76542

GSK Investigational Site, Killeen

76550

GSK Investigational Site, Lampasas

76712

GSK Investigational Site, Waco

77030

GSK Investigational Site, Houston

77058

GSK Investigational Site, Houston

77459

GSK Investigational Site, Missouri City

78233

GSK Investigational Site, Live Oak

78258

GSK Investigational Site, San Antonio

78577

GSK Investigational Site, Pharr

78726

GSK Investigational Site, Austin

79903

GSK Investigational Site, El Paso

80026

GSK Investigational Site, Lafayette

80045

GSK Investigational Site, Aurora

80230

GSK Investigational Site, Denver

80907

GSK Investigational Site, Colorado Springs

84025

GSK Investigational Site, Eboli (SA)

85234

GSK Investigational Site, Gilbert

85251

GSK Investigational Site, Scottsdale

85712

GSK Investigational Site, Tucson

90025

GSK Investigational Site, Los Angeles

90146

GSK Investigational Site, Palermo

90274

GSK Investigational Site, Rolling Hills Estates

90808

GSK Investigational Site, Long Beach

92024

GSK Investigational Site, Encinitas

92025

GSK Investigational Site, Escondico

92093

GSK Investigational Site, La Jolla

92123

GSK Investigational Site, San Diego

92647

GSK Investigational Site, Huntington Beach

92648

GSK Investigational Site, Huntington Beach

93030

GSK Investigational Site, Oxnard

95117

GSK Investigational Site, San Jose

95661

GSK Investigational Site, Roseville

97202

GSK Investigational Site, Portland

97223

GSK Investigational Site, Portland

97504

GSK Investigational Site, Medford

98115

GSK Investigational Site, Seattle

110117

GSK Investigational Site, Piteşti

150003

GSK Investigational Site, Yaroslavl

150047

GSK Investigational Site, Yaroslavl

153462

GSK Investigational Site, Ivanovo

163000

GSK Investigational Site, Arkhangelsk

170036

GSK Investigational Site, Tver'

185019

GSK Investigational Site, Petrozavodsk

193231

GSK Investigational Site, Saint Petersburg

194354

GSK Investigational Site, Saint Petersburg

195030

GSK Investigational Site, Saint Petersburg

196240

GSK Investigational Site, Saint Petersburg

197022

GSK Investigational Site, Saint Petersburg

198328

GSK Investigational Site, Saint Petersburg

200486

GSK Investigational Site, Craiova

300134

GSK Investigational Site, Timișoara

300310

GSK Investigational Site, Timișoara

308007

GSK Investigational Site, Belgorod

330084

GSK Investigational Site, Deva

350012

GSK Investigational Site, Krasnodar

400015

GSK Investigational Site, Cluj-Napoca

400162

GSK Investigational Site, Cluj-Napoca

400371

GSK Investigational Site, Cluj-Napoca

410028

GSK Investigational Site, Saratov

410053

GSK Investigational Site, Saratov

410176

GSK Investigational Site, Oradea

420008

GSK Investigational Site, Kazan'

426063

GSK Investigational Site, Izhevsk

432063

GSK Investigational Site, Ulyanovsk

443068

GSK Investigational Site, Samara

450071

GSK Investigational Site, Ufa

454006

GSK Investigational Site, Chelyabinsk

460040

GSK Investigational Site, Orenburg

500051

GSK Investigational Site, Brasov

500091

GSK Investigational Site, Brasov

540156

GSK Investigational Site, Târgu Mureş

600114

GSK Investigational Site, Bacau

614109

GSK Investigational Site, Perm

620137

GSK Investigational Site, Yekaterinburg

628012

GSK Investigational Site, Khantymansiysk

634028

GSK Investigational Site, Tomsk

650000

GSK Investigational Site, Kemerovo

650002

GSK Investigational Site, Kemerovo

660022

GSK Investigational Site, Krasnoyarsk

664043

GSK Investigational Site, Irkutsk

670031

GSK Investigational Site, Ulan-Ude

672000

GSK Investigational Site, Chita

675000

GSK Investigational Site, Blagoveshchensk

700115

GSK Investigational Site, Iași

720284

GSK Investigational Site, Suceava

800189

GSK Investigational Site, Galati

920013

GSK Investigational Site, Slobozia

92103-8415

GSK Investigational Site, San Diego

07712

GSK Investigational Site, Ocean City

14215-1199

GSK Investigational Site, Buffalo

02886

GSK Investigational Site, Warwick

C1414AIF

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

E3100BHK

GSK Investigational Site, Paraná

X5003DCE

GSK Investigational Site, Córdoba

S2000DBS

GSK Investigational Site, Rosario

S2000JKR

GSK Investigational Site, Rosario

C1121ABE

GSK Investigational Site, Buenos Aires

C1128AAF

GSK Investigational Site, Buenos Aires

C1424BSF

GSK Investigational Site, Buenos Aires

C1425BEN

GSK Investigational Site, Buenos Aires

M5500CCG

GSK Investigational Site, Mendoza

A1A 3R5

GSK Investigational Site, St. John's

L1S 2J5

GSK Investigational Site, Ajax

L6T 0G1

GSK Investigational Site, Brampton

L7N 3V2

GSK Investigational Site, Burlington

L8L 5G8

GSK Investigational Site, Hamilton

N5W 6A2

GSK Investigational Site, London

L4V 1P1

GSK Investigational Site, Mississauga

N7T 4X3

GSK Investigational Site, Sarnia

M3J 2C5

GSK Investigational Site, Toronto

M5T 3A9

GSK Investigational Site, Toronto

M9V 4B4

GSK Investigational Site, Toronto

N2J1C4

GSK Investigational Site, Waterloo

N8X 1T3

GSK Investigational Site, Windsor

N8X 2G1

GSK Investigational Site, Windsor

H4J 1C5

GSK Investigational Site, Montreal

J6E 2B4

GSK Investigational Site, Saint-Charles-Borromée

G8T 7A1

GSK Investigational Site, Trois-Rivières

G6P 6P6

GSK Investigational Site, Victoriaville

G1V 4G5

GSK Investigational Site, Québec

04109

GSK Investigational Site, Leipzg

04157

GSK Investigational Site, Leipzig

00168

GSK Investigational Site, Rome

00189

GSK Investigational Site, Rome

471-8513

GSK Investigational Site, Aichi

488-8585

GSK Investigational Site, Aichi

278-0004

GSK Investigational Site, Chiba

910-1193

GSK Investigational Site, Fukui

910-8526

GSK Investigational Site, Fukui

802-0052

GSK Investigational Site, Fukuoka

802-0083

GSK Investigational Site, Fukuoka

805-8508

GSK Investigational Site, Fukuoka

811-1394

GSK Investigational Site, Fukuoka

814-0180

GSK Investigational Site, Fukuoka

816-0813

GSK Investigational Site, Fukuoka

832-0059

GSK Investigational Site, Fukuoka

509-6134

GSK Investigational Site, Gifu

720-0001

GSK Investigational Site, Hiroshima

732-0052

GSK Investigational Site, Hiroshima

734-8530

GSK Investigational Site, Hiroshima

735-8585

GSK Investigational Site, Hiroshima

737-0193

GSK Investigational Site, Hiroshima

001-0901

GSK Investigational Site, Hokkaido

005-0841

GSK Investigational Site, Hokkaido

006-0811

GSK Investigational Site, Hokkaido

040-8611

GSK Investigational Site, Hokkaido

060-0033

GSK Investigational Site, Hokkaido

060-0061

GSK Investigational Site, Hokkaido

062-8618

GSK Investigational Site, Hokkaido

064-0801

GSK Investigational Site, Hokkaido

080-0024

GSK Investigational Site, Hokkaido

650-0047

GSK Investigational Site, Hyōgo

664-8540

GSK Investigational Site, Hyōgo

672-8064

GSK Investigational Site, Hyōgo

675-8611

GSK Investigational Site, Hyōgo

305-8576

GSK Investigational Site, Ibaraki

310-0015

GSK Investigational Site, Ibaraki

311-3193

GSK Investigational Site, Ibaraki

317-0077

GSK Investigational Site, Ibaraki

319-1113

GSK Investigational Site, Ibaraki

761-8073

GSK Investigational Site, Kagawa

761-8538

GSK Investigational Site, Kagawa

762-8550

GSK Investigational Site, Kagawa

210-0822

GSK Investigational Site, Kanagawa

224-8503

GSK Investigational Site, Kanagawa

231-8682

GSK Investigational Site, Kanagawa

232-0066

GSK Investigational Site, Kanagawa

236-0004

GSK Investigational Site, Kanagawa

252-0392

GSK Investigational Site, Kanagawa

607-8062

GSK Investigational Site, Kyoto

610-0113

GSK Investigational Site, Kyoto

612-0026

GSK Investigational Site, Kyoto

615-8087

GSK Investigational Site, Kyoto

515-8544

GSK Investigational Site, Mie

983-0833

GSK Investigational Site, Miyagi

983-8520

GSK Investigational Site, Miyagi

984-8560

GSK Investigational Site, Miyagi

986-8522

GSK Investigational Site, Miyagi

989-1253

GSK Investigational Site, Miyagi

386-8610

GSK Investigational Site, Nagano

850-0003

GSK Investigational Site, Nagasaki

632-8552

GSK Investigational Site, Nara

701-0304

GSK Investigational Site, Okayama

901-2121

GSK Investigational Site, Okinawa

901-2214

GSK Investigational Site, Okinawa

536-0001

GSK Investigational Site, Osaka

545-8586

GSK Investigational Site, Osaka

550-0006

GSK Investigational Site, Osaka

583-8588

GSK Investigational Site, Osaka

591-8037

GSK Investigational Site, Osaka

591-8555

GSK Investigational Site, Osaka

593-8304

GSK Investigational Site, Osaka

596-8501

GSK Investigational Site, Osaka

874-0011

GSK Investigational Site, Ōita

843-0393

GSK Investigational Site, Saga

333-0833

GSK Investigational Site, Saitama

351-0102

GSK Investigational Site, Saitama

690-8556

GSK Investigational Site, Shimane

421-0193

GSK Investigational Site, Shizuoka

438-8550

GSK Investigational Site, Shizuoka

103-0027

GSK Investigational Site, Tokyo

103-0028

GSK Investigational Site, Tokyo

104-8560

GSK Investigational Site, Tokyo

105-0003

GSK Investigational Site, Tokyo

142-8666

GSK Investigational Site, Tokyo

145-0063

GSK Investigational Site, Tokyo

145-0071

GSK Investigational Site, Tokyo

157-0066

GSK Investigational Site, Tokyo

158-0097

GSK Investigational Site, Tokyo

164-0012

GSK Investigational Site, Tokyo

169-0073

GSK Investigational Site, Tokyo

171-0014

GSK Investigational Site, Tokyo

187-0024

GSK Investigational Site, Tokyo

937-0042

GSK Investigational Site, Toyama

990-8533

GSK Investigational Site, Yamagata

992-0045

GSK Investigational Site, Yamagata

755-0241

GSK Investigational Site, Yamaguchi

400-0031

GSK Investigational Site, Yamanashi

1815 JD

GSK Investigational Site, Alkmaar

1311 RL

GSK Investigational Site, Almere Stad

6191 JW

GSK Investigational Site, Beek

4818 CK

GSK Investigational Site, Breda

5623 EJ

GSK Investigational Site, Eindhoven

7555 DL

GSK Investigational Site, Hengelo

2333 ZA

GSK Investigational Site, Leiden

3051 GV

GSK Investigational Site, Rotterdam

3067 GJ

GSK Investigational Site, Rotterdam

3083 AN

GSK Investigational Site, Rotterdam

3511 NH

GSK Investigational Site, Utrecht

15-183

GSK Investigational Site, Bialystok

85-681

GSK Investigational Site, Bydgoszcz

86-300

GSK Investigational Site, Grudziądz

64-000

GSK Investigational Site, Kościan

31-209

GSK Investigational Site, Krakow

31-637

GSK Investigational Site, Krakow

90-302

GSK Investigational Site, Lodz

20-089

GSK Investigational Site, Lublin

27-400

GSK Investigational Site, Ostrowiec Świętokrzyski

60-823

GSK Investigational Site, Poznan

35-051

GSK Investigational Site, Rzeszów

81-741

GSK Investigational Site, Sopot

71-124

GSK Investigational Site, Szczecin

76-200

GSK Investigational Site, Słupsk

33-100

GSK Investigational Site, Tarnów

95-100

GSK Investigational Site, Zgierz

012363

GSK Investigational Site, Bucharest

014452

GSK Investigational Site, Bucharest

020125

GSK Investigational Site, Bucharest

030317

GSK Investigational Site, Bucharest

040069

GSK Investigational Site, Bucharest

050159

GSK Investigational Site, Bucharest

115 280

GSK Investigational Site, Moscow

634 050

GSK Investigational Site, Tomsk

0183

GSK Investigational Site, Pretoria West

602-715

GSK Investigational Site, Busan

705-703

GSK Investigational Site, Daegu

05505

GSK Investigational Site, Seoul

06591

GSK Investigational Site, Seoul

110-744

GSK Investigational Site, Seoul

130-709

GSK Investigational Site, Seoul

140-887

GSK Investigational Site, Seoul

443-380

GSK Investigational Site, Suwon-si, Gyeonggi-do

220-701

GSK Investigational Site, Wonju-si, Kanwon-do

08916

GSK Investigational Site, Badalona

08003

GSK Investigational Site, Barcelona

08006

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

09006

GSK Investigational Site, Burgos

08907

GSK Investigational Site, L'Hospitalet de Llobregat

AB25 2ZG

GSK Investigational Site, Aberdeen

RM1 3PJ

GSK Investigational Site, Romford

ML2 0DP

GSK Investigational Site, Wishaw

FY3 7EN

GSK Investigational Site, Blackpool

HA6 2RN

GSK Investigational Site, Northwood

NN17 2UR

GSK Investigational Site, Corby

TN40 1JJ

GSK Investigational Site, Bexhill-on-Sea

BD9 6RJ

GSK Investigational Site, Bradford

B15 2GW

GSK Investigational Site, Edgbaston

L7 8XP

GSK Investigational Site, Liverpool

DA14 6LT

GSK Investigational Site, Sidcup, Kent

BA14 9AR

GSK Investigational Site, Trowbridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02924688 - A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma | Biotech Hunter | Biotech Hunter