The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

247

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

QVA149

QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI

DRUG

Tiotropium

Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

DRUG

Placebo to QVA149

Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI

DRUG

Placebo to tiotropium

Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

DRUG

Salbutamol/albuterol

salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Trial Locations (43)

1000

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Jette

1301

Novartis Investigative Site, Wavre

3000

Novartis Investigative Site, Leuven

4000

Novartis Investigative Site, Liège

5100

Novartis Investigative Site, Jambes

6060

Novartis Investigative Site, Gilly

8400

Novartis Investigative Site, Ostend

10789

Novartis Investigative Site, Berlin

12099

Novartis Investigative Site, Berlin

12203

Novartis Investigative Site, Berlin

13156

Novartis Investigative Site, Berlin

14467

Novartis Investigative Site, Potsdam

14478

Novartis Investigative Site, Potsdam

15562

Novartis Investigative Site, Rüdersdorf

24400

Novartis Investigative Site, Ponferrada

28007

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

30317

Novartis Investigative Site, Hanover

48431

Novartis Investigative Site, Rheine

60389

Novartis Investigative Site, Frankfurt

63739

Novartis Investigative Site, Aschaffenburg

L7N 3V2

Novartis Investigative Site, Burlington

L5M 2V8

Novartis Investigative Site, Mississauga

M5G1N8

Novartis Investigative Site, Toronto

M6H 3M2

Novartis Investigative Site, Toronto

H7S 2M5

Novartis Investigative Site, Laval

J7J 2K8

Novartis Investigative Site, Mirabel

J6E 6J2

Novartis Investigative Site, Saint-Charles-Borromée

04207

Novartis Investigative Site, Leipzig

D-55101

Novartis Investigative Site, Mainz

03050

Novartis Investigative Site, Cottbus

06108

Novartis Investigative Site, Halle

04103

Novartis Investigative Site, Leipzig

04275

Novartis Investigative Site, Leipzig

04357

Novartis Investigative Site, Leipzig

06800

Novartis Investigative Site, Mérida

08914

Novartis Investigative Site, Badalona

M6 8HD

Novartis Investigative Site, Salford

BD9 6RJ

Novartis Investigative Site, Bradford

G11 6NT

Novartis Investigative Site, Glasgow

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

PO6 3AD

Novartis Investigative Site, Portsmouth

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY