Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

657

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

NVA237

NVA237 50 μg inhalation capsules once a day, delivered via SDDPI

DRUG

Tiotropium

Tiotropium 18 μg once a day delivered via HandiHaler® device

DRUG

Placebo to tiotropium

Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.

DRUG

Placebo to NVA237

Placebo to NVA237 50 μg once a day delivered via SDDPI

DRUG

salbutamol/albuterol

salbutamol/albuterol given as a rescue medication via inhaler when needed

Trial Locations (77)

600

Novartis Investigative Site, Chiayi City

1000

Novartis Investigative Site, Manila

1002

Novartis Investigative Site, Riga

1100

Novartis Investigative Site, Quezon City

3020

Novartis Investigative Site, Bulacan

4217

Novartis Investigative Site, Lipa City

7500

Novartis Investigative Site, Cape Town

7764

Novartis Investigative Site, Gatesville

7925

Novartis Investigative Site, Cape Town

10000

Novartis Investigative Site, Zagreb

10117

Novartis Investigative Site, Berlin

13419

Novartis Investigative Site, Tallinn

13619

Novartis Investigative Site, Tallinn

14050

Novartis Investigative Site, Berlin

Novartis Investigative Site, Berlin

14478

Novartis Investigative Site, Potsdam

15562

Novartis Investigative Site, Rüdersdorf

20253

Novartis Investigative Site, Hamburg

25219

Novartis Investigative Site, Rudná

34121

Novartis Investigative Site, Kassel

40447

Novartis Investigative Site, Taichung

44000

Novartis Investigative Site, Sisak

Novartis Investigative Site, Nantes

51014

Novartis Investigative Site, Tartu

51092

Novartis Investigative Site, Reims

60596

Novartis Investigative Site, Frankfurt

62660

Novartis Investigative Site, Beuvry

65187

Novartis Investigative Site, Wiesbaden

69317

Novartis Investigative Site, Lyon

72714

Novartis Investigative Site, Paide

83301

Novartis Investigative Site, Niaosong Township

92288

Novartis Investigative Site, Klaipėda

641014

Novartis Investigative Site, Coimbatore

M5G1N8

Novartis Investigative Site, Toronto

M5T 3A9

Novartis Investigative Site, Toronto

M6H 3M2

Novartis Investigative Site, Toronto

J8Y 6S8

Novartis Investigative Site, Gatineau

J7J 2K8

Novartis Investigative Site, Mirabel

J6E 6J2

Novartis Investigative Site, Saint-Charles-Borromée

10 000

Novartis Investigative Site, Zagreb

471 54

Novartis Investigative Site, Cvikov

460 01

Novartis Investigative Site, Liberec

108 00

Novartis Investigative Site, Prague

140 46

Novartis Investigative Site, Prague

169 00

Novartis Investigative Site, Prague

415 01

Novartis Investigative Site, Teplice

438 01

Novartis Investigative Site, Žatec

04207

Novartis Investigative Site, Leipzig

01010

Novartis Investigative Site, Guatemala City

01011

Novartis Investigative Site, Guatemala City

522 001

Novartis Investigative Site, Guntur

380 009

Novartis Investigative Site, Ahmedabad

600 087

Novartis Investigative Site, Chennai - Tamil Nadu

560 010

Novartis Investigative Site, Bangalore

Unknown

Novartis Investigative Site, Nagpur

Novartis Investigative Site, Bucheon-si

Novartis Investigative Site, Taipei County

Novartis Investigative Site, Chiayi City

641 045

Novartis Investigative Site, Coimbatore

LV-5401

Novartis Investigative Site, Daugavpils

LT-62114

Novartis Investigative Site, Alytus

LT-47144

Novartis Investigative Site, Kaunas

LT-92231

Novartis Investigative Site, Klaipėda

LT-28151

Novartis Investigative Site, Utena

06001

Novartis Investigative Site, Vilnius

LT-08661

Novartis Investigative Site, Vilnius

80-169

Novartis Investigative Site, Gdansk

80-847

Novartis Investigative Site, Gdansk

40-752

Novartis Investigative Site, Katowice

60-693

Novartis Investigative Site, Poznan

51-162

Novartis Investigative Site, Wroclaw

602-739

Novartis Investigative Site, Busan

130-709

Novartis Investigative Site, Seoul

156-755

Novartis Investigative Site, Seoul

705-717

Novartis Investigative Site, Daegu

130-702

Novartis Investigative Site, Seoul

152-703

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY