NCT02301975View on ClinicalTrials.gov

An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,526

Participants

Timeline

Start Date

March 1, 2015

Primary Completion Date

November 1, 2016

Study Completion Date

November 25, 2016

Conditions
Asthma
Interventions
DRUG

Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler

FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation.

DRUG

Placebo inhalation powders via ELLIPTA inhaler

Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device.

DRUG

Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler

FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation.

DRUG

Placebo inhalation powder via ACCUHALER/DISKUS inhaler

Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device.

DRUG

Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler

FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation.

Trial Locations (179)

1602

GSK Investigational Site, Florida

1900

GSK Investigational Site, La Plata

4000

GSK Investigational Site, San Miguel de Tucumán

5500

GSK Investigational Site, Mendoza

6682

GSK Investigational Site, Teuchern

7600

GSK Investigational Site, Mar del Plata

10119

GSK Investigational Site, Berlin

10367

GSK Investigational Site, Berlin

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

10969

GSK Investigational Site, Berlin

12203

GSK Investigational Site, Berlin

13156

GSK Investigational Site, Berlin

14469

GSK Investigational Site, Potsdam

15706

GSK Investigational Site, Santiago de Compostela

16499

GSK Investigational Site, Suwon-si, Gyeonggi-do

18020

GSK Investigational Site, Bethlehem

21044

GSK Investigational Site, Columbia

21236

GSK Investigational Site, Baltimore

21502

GSK Investigational Site, Geesthacht

22299

GSK Investigational Site, Hamburg

23225

GSK Investigational Site, Richmond

23552

GSK Investigational Site, Lübeck

24837

GSK Investigational Site, Schleswig

28009

GSK Investigational Site, Madrid

28054

GSK Investigational Site, Gastonia

28078

GSK Investigational Site, Huntersville

28223

GSK Investigational Site, Pozuelo de Alarcón/Madrid

28277

GSK Investigational Site, Charlotte

28739

GSK Investigational Site, Hendersonville

29118

GSK Investigational Site, Orangeburg

29303

GSK Investigational Site, Spartanburg

29615

GSK Investigational Site, Greenville

29732

GSK Investigational Site, Rock Hill

30173

GSK Investigational Site, Hanover

31224

GSK Investigational Site, Peine

31707

GSK Investigational Site, Albany

33165

GSK Investigational Site, Miami

33174

GSK Investigational Site, Miami

35037

GSK Investigational Site, Marburg

39008

GSK Investigational Site, Santander

44130

GSK Investigational Site, Middleburg Heights

44718

GSK Investigational Site, Canton

45030

GSK Investigational Site, Zapopan

45070

GSK Investigational Site, Zapopan

45231

GSK Investigational Site, Cincinnati

45355

GSK Investigational Site, Essen

45359

GSK Investigational Site, Essen

46015

GSK Investigational Site, Valencia

46600

GSK Investigational Site, Alzira/Valencia

48231

GSK Investigational Site, Warendorf

53228

GSK Investigational Site, Greenfield

55402

GSK Investigational Site, Minneapolis

55441

GSK Investigational Site, Plymouth

56068

GSK Investigational Site, Koblenz

58070

GSK Investigational Site, Morelia

58452

GSK Investigational Site, Witten

60389

GSK Investigational Site, Frankfurt am Main

60596

GSK Investigational Site, Frankfurt am Main

63263

GSK Investigational Site, Neu-Isenburg

64718

GSK Investigational Site, Monterrey NL

65203

GSK Investigational Site, Columbia

65401

GSK Investigational Site, Rolla

70378

GSK Investigational Site, Stuttgart

70868

GSK Investigational Site, Ostrava - Poruba

75067

GSK Investigational Site, Lewisville

76712

GSK Investigational Site, Waco

78750

GSK Investigational Site, Austin

80230

GSK Investigational Site, Denver

80339

GSK Investigational Site, Munich

80539

GSK Investigational Site, Munich

86035

GSK Investigational Site, Villahermosa

90274

GSK Investigational Site, Rolling Hills Estates

91786

GSK Investigational Site, Upland

92103

GSK Investigational Site, San Diego

92506

GSK Investigational Site, Riverside

92647

GSK Investigational Site, Huntington Beach

96049

GSK Investigational Site, Bamberg

97504

GSK Investigational Site, Medford

110084

GSK Investigational Site, Piteşti

115201

GSK Investigational Site, Moscow

115478

GSK Investigational Site, Moscow

125315

GSK Investigational Site, Moscow

194354

GSK Investigational Site, Saint Petersburg

194356

GSK Investigational Site, Saint Petersburg

195030

GSK Investigational Site, Saint Petesburg

196240

GSK Investigational Site, Saint Petersburg

197706

GSK Investigational Site, St'Petersburg

200345

GSK Investigational Site, Craiova

300310

GSK Investigational Site, Timișoara

330182

GSK Investigational Site, Deva

347381

GSK Investigational Site, Volgodonsk

350012

GSK Investigational Site, Krasnodar

355017

GSK Investigational Site, Stavropol

357538

GSK Investigational Site, Pyatigorsk

394018

GSK Investigational Site, Voronezh

400371

GSK Investigational Site, Cluj-Napoca

410028

GSK Investigational Site, Saratov

432063

GSK Investigational Site, Ulyanovsk

450071

GSK Investigational Site, Ufa

500112

GSK Investigational Site, Brasov

505100

GSK Investigational Site, Codlea

600023

GSK Investigational Site, Vladimir

600114

GSK Investigational Site, Bacau

600252

GSK Investigational Site, Bacau

634009

GSK Investigational Site, Tomsk

634033

GSK Investigational Site, Tomsk

644112

GSK Investigational Site, Omsk

650000

GSK Investigational Site, Kemerovo

650002

GSK Investigational Site, Kemerovo

664043

GSK Investigational Site, Irkutsk

675000

GSK Investigational Site, Blagoveshchensk

720284

GSK Investigational Site, Suceava

2341131

GSK Investigational Site, Valparaíso

2520594

GSK Investigational Site, Viña del Mar

4070038

GSK Investigational Site, Concepción

7500692

GSK Investigational Site, Santiago

7500698

GSK Investigational Site, Santiago

7500710

GSK Investigational Site, Santiago

7510186

GSK Investigational Site, Santiago

41940455

GSK Investigational Site, Salvador

68123-4303

GSK Investigational Site, Bellevue

B1878FNR

GSK Investigational Site, Quilmes

S2000DBS

GSK Investigational Site, Rosario

S2000JKR

GSK Investigational Site, Rosario

C1121ABE

GSK Investigational Site, Buenos Aires

C1424BSF

GSK Investigational Site, Buenos Aires

C1425BEN

GSK Investigational Site, Buenos Aires

C1426ABP

GSK Investigational Site, Buenos Aires

B7600FYK

GSK Investigational Site, Mar del Plata

M5500CCG

GSK Investigational Site, Mendoza

74110 030

GSK Investigational Site, Goiânia

90610-000

GSK Investigational Site, Porto Alegre

01323903

GSK Investigational Site, São Paulo

04266-010

GSK Investigational Site, São Paulo

470 01

GSK Investigational Site, Česká Lípa

748 01

GSK Investigational Site, Hlučín

500 02

GSK Investigational Site, Hradec Králové

284 01

GSK Investigational Site, Kutná Hora

410 02

GSK Investigational Site, Lovosice

772 00

GSK Investigational Site, Olomouc

337 01

GSK Investigational Site, Rokycany

390 01

GSK Investigational Site, Tábor

415 10

GSK Investigational Site, Teplice

407 47

GSK Investigational Site, Varnsdorf

04509

GSK Investigational Site, Delitzsch

04109

GSK Investigational Site, Leipzg

04207

GSK Investigational Site, Leipzig

04275

GSK Investigational Site, Leipzig

04357

GSK Investigational Site, Leipzig

04626

GSK Investigational Site, Schmölln

01710

GSK Investigational Site, Mexico City

7609 PP

GSK Investigational Site, Almelo

1311 RL

GSK Investigational Site, Almere Stad

1315 RC

GSK Investigational Site, Almere Stad

4818 CK

GSK Investigational Site, Breda

4819 EV

GSK Investigational Site, Breda

5623 EJ

GSK Investigational Site, Eindhoven

3844 DG

GSK Investigational Site, Harderwijk

1624 NP

GSK Investigational Site, Hoorn

7694 AC

GSK Investigational Site, Kloosterhaar

7442 LS

GSK Investigational Site, Nijverdal

7207 AE

GSK Investigational Site, Zutphen

020125

GSK Investigational Site, Bucharest

022102

GSK Investigational Site, Bucharest

030317

GSK Investigational Site, Bucharest

050159

GSK Investigational Site, Bucharest

656 045

GSK Investigational Site, Barnaul

123 182

GSK Investigational Site, Moscow

361-763

GSK Investigational Site, Cheongju-si, Chungcheongbuk-do

403-720

GSK Investigational Site, Incheon

110-744

GSK Investigational Site, Seoul

135-710

GSK Investigational Site, Seoul

138-736

GSK Investigational Site, Seoul

03004

GSK Investigational Site, Alicante

08916

GSK Investigational Site, Badalona

08016

GSK Investigational Site, Barcelona

08035

GSK Investigational Site, Barcelona

08540

GSK Investigational Site, Centelles (Barcelona)

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02301975 - An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma | Biotech Hunter | Biotech Hunter