Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

PHASE4CompletedINTERVENTIONAL
Enrollment

1,053

Participants

Timeline

Start Date

November 20, 2015

Primary Completion Date

July 18, 2017

Study Completion Date

July 18, 2017

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

QVA149

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI

DRUG

Tiotropium

Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®

DRUG

Salmeterol/fluticasone

Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

Trial Locations (167)

1011

Novartis Investigative Site, Riga

1121

Novartis Investigative Site, Budapest

2045

Novartis Investigative Site, Törökbálint

2060

Novartis Investigative Site, Antwerp

2300

Novartis Investigative Site, Turnhout

2400

Novartis Investigative Site, Copenhagen NV

2440

Novartis Investigative Site, Százhalombatta

2650

Novartis Investigative Site, Hvidovre

2660

Novartis Investigative Site, Balassagyarmat

3260

Novartis Investigative Site, Concepción del Uruguay

3300

Novartis Investigative Site, Amstetten

3500

Novartis Investigative Site, Hasselt

4000

Novartis Investigative Site, San Miguel de Tucumán

4501

Novartis Investigative Site, Balvi

4600

Novartis Investigative Site, Thalheim bei Wels

4710

Novartis Investigative Site, Grieskirchen

5100

Novartis Investigative Site, Erpent

5300

Novartis Investigative Site, Gabrovo

5310

Novartis Investigative Site, Éghezée

5601

Novartis Investigative Site, Krāslava

6000

Novartis Investigative Site, Stara Zagora

6800

Novartis Investigative Site, Feldkirch

7000

Novartis Investigative Site, Rousse

7100

Novartis Investigative Site, Szekszárd

7600

Novartis Investigative Site, Mar del Plata

8330

Novartis Investigative Site, Feldbach

9000

Novartis Investigative Site, Varna

10000

Novartis Investigative Site, Zagreb

10117

Novartis Investigative Site, Berlin

10119

Novartis Investigative Site, Berlin

10138

Novartis Investigative Site, Tallinn

10367

Novartis Investigative Site, Berlin

10457

Novartis Investigative Site, Bucharest

10625

Novartis Investigative Site, Berlin

10717

Novartis Investigative Site, Berlin

10787

Novartis Investigative Site, Berlin

10969

Novartis Investigative Site, Berlin

11000

Novartis Investigative Site, Belgrade

Novartis Investigative Site, Belgrade

12157

Novartis Investigative Site, Berlin

12159

Novartis Investigative Site, Berlin

12203

Novartis Investigative Site, Berlin

13156

Novartis Investigative Site, Berlin

13419

Novartis Investigative Site, Tallinn

14000

Novartis Investigative Site, Valjevo

14467

Novartis Investigative Site, Potsdam

14469

Novartis Investigative Site, Potsdam

15562

Novartis Investigative Site, Rudersdorf

18204

Novartis Investigative Site, Knez-Selo

20354

Novartis Investigative Site, Hamburg

22143

Novartis Investigative Site, Hamburg

23552

Novartis Investigative Site, Lübeck

24400

Novartis Investigative Site, Ponferrada

24837

Novartis Investigative Site, Schleswig

25001

Novartis Investigative Site, Brandýs nad Labem

25601

Novartis Investigative Site, Benešov

29010

Novartis Investigative Site, Málaga

30159

Novartis Investigative Site, Hanover

30322

Novartis Investigative Site, Kohtla-Järve

31224

Novartis Investigative Site, Peine

32800

Novartis Investigative Site, Pilsen

34000

Novartis Investigative Site, Kragujevac

35037

Novartis Investigative Site, Marburg

39112

Novartis Investigative Site, Magdeburg

42651

Novartis Investigative Site, Solingen

46600

Novartis Investigative Site, Alzira

48231

Novartis Investigative Site, Warendorf

51000

Novartis Investigative Site, Rijeka

51014

Novartis Investigative Site, Tartu

53123

Novartis Investigative Site, Bonn

56068

Novartis Investigative Site, Koblenz

58089

Novartis Investigative Site, Hagen

58706

Novartis Investigative Site, Menden

60389

Novartis Investigative Site, Frankfurt am Main

60596

Novartis Investigative Site, Frankfurt

63263

Novartis Investigative Site, Neu-Isenburg

63400

Novartis Investigative Site, Ostrów Wielkopolski

69168

Novartis Investigative Site, Wiesloch

86825

Novartis Investigative Site, Bad Wörishofen

91052

Novartis Investigative Site, Erlangen

300310

Novartis Investigative Site, Timișoara

303330

Novartis Investigative Site, Bucharest

310013

Novartis Investigative Site, Arad

310416

Novartis Investigative Site, Arad

330162

Novartis Investigative Site, Deva

400371

Novartis Investigative Site, Cluj-Napoca

500086

Novartis Investigative Site, Brasov

C1425BEN

Novartis Investigative Site, CABA

B8000XAV

Novartis Investigative Site, Lanús

B7600FZN

Novartis Investigative Site, Mar del Plata

B1878FNR

Novartis Investigative Site, Quilmes

T4000IFL

Novartis Investigative Site, San Miguel de Tucumán

Unknown

Novartis Investigative Site, CABA

C1425FVH

Novartis Investigative Site, Ciudad Autonoma de Bs As

M5500CBA

Novartis Investigative Site, Mendoza

V5Z 4E1

Novartis Investigative Site, Vancouver

E1G 1A7

Novartis Investigative Site, Moncton

L7N 3V2

Novartis Investigative Site, Burlington

M5T 3A9

Novartis Investigative Site, Toronto

M6H 3M2

Novartis Investigative Site, Toronto

J8Y 6S8

Novartis Investigative Site, Gatineau

G1G 3Y8

Novartis Investigative Site, Québec

G1W 4R4

Novartis Investigative Site, Québec

G3K 2P8

Novartis Investigative Site, Québec

J6E 2B4

Novartis Investigative Site, Saint-Charles-Borromée

G6P 6P6

Novartis Investigative Site, Victoriaville

267 01

Novartis Investigative Site, Mělník

697 33

Novartis Investigative Site, Kyjov

03050

Novartis Investigative Site, Cottbus

01069

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

04109

Novartis Investigative Site, Leipzig

04207

Novartis Investigative Site, Leipzig

04357

Novartis Investigative Site, Leipzig

04758

Novartis Investigative Site, Oschatz

711 10

Novartis Investigative Site, Heraklion - Crete

570 10

Novartis Investigative Site, Thessaloniki

106 76

Novartis Investigative Site, Athens

LV-2015

Novartis Investigative Site, Jūrmala

LV-3414

Novartis Investigative Site, Liepāja

LV-5401

Novartis Investigative Site, Daugavpils

LV 1002

Novartis Investigative Site, Riga

LV-1038

Novartis Investigative Site, Riga

LT-50128

Novartis Investigative Site, Kaunas

LT-92231

Novartis Investigative Site, Klaipėda

LT-92288

Novartis Investigative Site, Klaipėda

LT-28151

Novartis Investigative Site, Utena

06122

Novartis Investigative Site, Vilnius

LT-08661

Novartis Investigative Site, Vilnius

1814HB

Novartis Investigative Site, Alkmaar

4819 EV

Novartis Investigative Site, Breda

5623 EJ

Novartis Investigative Site, Eindhoven

7207 AE

Novartis Investigative Site, Zutphen

53-301

Novartis Investigative Site, Wroclaw

15-044

Novartis Investigative Site, Bialystok

15-270

Novartis Investigative Site, Bialystok

15-351

Novartis Investigative Site, Bialystok

34-212

Novartis Investigative Site, Bieńkówka

31-023

Novartis Investigative Site, Krakow

90-153

Novartis Investigative Site, Lodz

20-045

Novartis Investigative Site, Lublin

60-214

Novartis Investigative Site, Poznan

60-823

Novartis Investigative Site, Poznan

81-741

Novartis Investigative Site, Sopot

33-100

Novartis Investigative Site, Tarnów

50-434

Novartis Investigative Site, Wroclaw

27-400

Novartis Investigative Site, Ostrowiec Swietokrzyskie

012051

Novartis Investigative Site, Bucharest

050159

Novartis Investigative Site, Bucharest

06601

Novartis Investigative Site, Humenné

058 01

Novartis Investigative Site, Poprad

080 01

Novartis Investigative Site, Prešov

052 01

Novartis Investigative Site, Spišská Nová Ves

08540

Novartis Investigative Site, Centelles

08360

Novartis Investigative Site, Canet de Mar

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

06800

Novartis Investigative Site, Mérida

03550

Novartis Investigative Site, Sant Joan d'Alacant

CV32 4RA

Novartis Investigative Site, Royal Leamington Spa

RH10 7DX

Novartis Investigative Site, Crawley

BD9 6RJ

Novartis Investigative Site, Bradford

BA2 3HT

Novartis Investigative Site, Bath

B15 2TH

Novartis Investigative Site, Birmingham

B9 5SS

Novartis Investigative Site, Birmingham

CV2 2DX

Novartis Investigative Site, Coventry

PL5 3JB

Novartis Investigative Site, Plymouth

WV10 0QP

Novartis Investigative Site, Wolverhampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY