Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

PHASE3CompletedINTERVENTIONAL
Enrollment

1,215

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

QVA149

QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI

DRUG

Tiotropium

Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI

DRUG

placebo

placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI

Trial Locations (116)

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Novartis Investigative Site, Riga

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Novartis Investigative Site, Caba

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Novartis Investigative Site, Budapest

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Novartis Investigative Site, Pendik / Istanbul

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Novartis Investigative Site, Buenos Aires

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Novartis Investigative Site, Gödöllő

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Novartis Investigative Site, Monor

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Novartis Investigative Site, Cegléd

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Novartis Investigative Site, Eger

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Novartis Investigative Site, Salta

Novartis Investigative Site, San Miguel de Tucumán

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Novartis Investigative Site, Debrecen

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Novartis Investigative Site, Golnik

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Novartis Investigative Site, Mendoza

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Novartis Investigative Site, Szarvas

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Novartis Investigative Site, Siófok

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Novartis Investigative Site, Mosonmagyaróvár

10000

Novartis Investigative Site, Zagreb

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Novartis Investigative Site, Tallinn

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Novartis Investigative Site, Tallinn

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Novartis Investigative Site, Mexico City

14584

Novartis Investigative Site, Bucheon-si

18204

Novartis Investigative Site, Knez-Selo

31000

Novartis Investigative Site, Osijek

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Novartis Investigative Site, Mersin

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Novartis Investigative Site, Kragujevac

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Novartis Investigative Site, Kartal

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Novartis Investigative Site, Yenisehir/Izmir

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Novartis Investigative Site, León

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Novartis Investigative Site, Kocaeli

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Novartis Investigative Site, Pachuca

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Novartis Investigative Site, Sisak

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Novartis Investigative Site, Petah Tikva

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Novartis Investigative Site, Tartu

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Novartis Investigative Site, Rehovot

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Novartis Investigative Site, Jerusalem

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Novartis Investigative Site, Moscow

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Novartis Investigative Site, Moscow

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Novartis Investigative Site, Yaroslavl

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Novartis Investigative Site, Saint Petersburg

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Novartis Investigative Site, Saint Petersburg

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Novartis Investigative Site, Saint Petersburg

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Novartis Investigative Site, Jaipur

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Novartis Investigative Site, Ahmedabad

390026

Novartis Investigative Site, Ryazan

410012

Novartis Investigative Site, Saratov

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Novartis Investigative Site, Nagpur - Maharashtra

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Novartis Investigative Site, Nagpur

500004

Novartis Investigative Site, Hyderabad

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Novartis Investigative Site, Bangalore

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Novartis Investigative Site, Mysore

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Novartis Investigative Site, Nizhny Novgorod

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Novartis Investigative Site, N.Novgorod

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Novartis Investigative Site, Vellore

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Novartis Investigative Site, Jerusalem

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Novartis Investigative Site, Buenos Aires

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Novartis Investigative Site, Caba

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Novartis Investigative Site, Caba

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Novartis Investigative Site, Caba

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Novartis Investigative Site, Caba

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B8000XAV

Novartis Investigative Site, Lanús

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Novartis Investigative Site, San Juan Bautista

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Novartis Investigative Site, Corrientes

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Novartis Investigative Site, Concepción del Uruguay

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Novartis Investigative Site, Mendoza

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Novartis Investigative Site, Santa Fe

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Novartis Investigative Site, Rosario

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Novartis Investigative Site, Santa Fe

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Novartis Investigative Site, Santa Fe

Unknown

Novartis Investigative Site, Bogota

Novartis Investigative Site, Armenia

Novartis Investigative Site, Barranquilla

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Panama City

10 000

Novartis Investigative Site, Zagreb

H-2030

Novartis Investigative Site, Érd

H-9300

Novartis Investigative Site, Csorna

500 001

Novartis Investigative Site, Hyderabad

403 002

Novartis Investigative Site, Panjim

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Novartis Investigative Site, Trivandrum

334 001

Novartis Investigative Site, Bikaner

302 039

Novartis Investigative Site, Jaipur

641 045.

Novartis Investigative Site, Coimbatore

LV-5401

Novartis Investigative Site, Daugavpils

LV-1038

Novartis Investigative Site, Riga

06726

Novartis Investigative Site, Mexico City

0834-00363

Novartis Investigative Site, Panama City

15-044

Novartis Investigative Site, Bialystok

40-752

Novartis Investigative Site, Katowice

31-159

Novartis Investigative Site, Krakow

90-153

Novartis Investigative Site, Lodz

90-302

Novartis Investigative Site, Lodz

03080

Novartis Investigative Site, Seoul

130-709

Novartis Investigative Site, Seoul

156-755

Novartis Investigative Site, Seoul

705-703

Novartis Investigative Site, Daegu

403-720

Novartis Investigative Site, Incheon

405-760

Novartis Investigative Site, Incheon

130-872

Novartis Investigative Site, Seoul

CV32 4RA

Novartis Investigative Site, Royal Leamington Spa

BD9 6RJ

Novartis Investigative Site, Bradford

B15 2WB

Novartis Investigative Site, Birmingham

B9 5SS

Novartis Investigative Site, Birmingham

CW1 4QJ

Novartis Investigative Site, Cheshire

DN2 5LT

Novartis Investigative Site, Doncaster

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Novartis Investigative Site, Leeds

CH49 5PE

Novartis Investigative Site, Merseyside

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Novartis Investigative Site, Newport

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Novartis Investigative Site, Portsmouth

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Novartis Investigative Site, Wolverhampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY