Exacerbation Study (INVIGORATE)

September 16, 2013 updated by: Novartis Pharmaceuticals

A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Study Overview

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3439

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Novartis Investigative Site
  - Buenos Aires, Argentina, B1842DID
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1122AAK
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1125ABE
    - Novartis Investigative Site
  - Buenos Aires, Argentina, 5000
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1426ABP
    - Novartis Investigative Site
  - Buenos aires, Argentina, C1221ADC
    - Novartis Investigative Site
  - Mendoza, Argentina, M5500CCG
    - Novartis Investigative Site
- Buenos Aires
  - Capital Federal, Buenos Aires, Argentina, C1424BSF
    - Novartis Investigative Site
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - Novartis Investigative Site
  - Pilar, Buenos Aires, Argentina, B1629AHJ
    - Novartis Investigative Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, C2000DSR
    - Novartis Investigative Site
  - Rosario, Santa Fe, Argentina, S2000AYW
    - Novartis Investigative Site
- Tucuman
  - San Miguel de Tucuman, Tucuman, Argentina, 4000
    - Novartis Investigative Site
Australia
- - Tauranga, New Zealand, Australia, 3001
    - Novartis Investigative Site
- New South Wales
  - Bankstown, New South Wales, Australia, 2200
    - Novartis Investigative Site
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Novartis Investigative Site
  - Daw Park, South Australia, Australia, 5041
    - Novartis Investigative Site
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - Novartis Investigative Site
  - Parkville, Victoria, Australia, 3050
    - Novartis Investigative Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Novartis Investigative Site
Austria
- - Feldbach, Austria, 8330
    - Novartis Investigative Site
  - Grieskirchen, Austria, 4710
    - Novartis Investigative Site
  - Gänserndorf, Austria, 2230
    - Novartis Investigative Site
  - Hallein, Austria, 5400
    - Novartis Investigative Site
  - Linz, Austria, 4020
    - Novartis Investigative Site
  - Perg, Austria, 4320
    - Novartis Investigative Site
  - Zwettl, Austria, 3910
    - Novartis Investigative Site
Belgium
- - Aalst, Belgium, 9300
    - Novartis Investigative Site
  - Antwerpen, Belgium, 2020
    - Novartis Investigative Site
  - Bruxelles, Belgium, 1200
    - Novartis Investigative Site
  - Bruxelles, Belgium, 1000
    - Novartis Investigative Site
  - Duffel, Belgium, 2570
    - Novartis Investigative Site
  - Eupen, Belgium, 4700
    - Novartis Investigative Site
  - Framerie, Belgium, 7080
    - Novartis Investigative Site
  - Geraardsbergen, Belgium, 9500
    - Novartis Investigative Site
  - Gilly, Belgium, 6060
    - Novartis Investigative Site
  - Godinne, Belgium, 5530
    - Novartis Investigative Site
  - Gozée, Belgium, 6534
    - Novartis Investigative Site
  - Herentals, Belgium, 2200
    - Novartis Investigative Site
  - Jambes, Belgium, 5100
    - Novartis Investigative Site
  - Jette, Belgium, 1090
    - Novartis Investigative Site
  - Kortrijk, Belgium, 8500
    - Novartis Investigative Site
  - Leuven, Belgium, 3000
    - Novartis Investigative Site
  - Liege, Belgium, 4000
    - Novartis Investigative Site
  - Liège, Belgium, 4000
    - Novartis Investigative Site
  - Malmedy, Belgium, 4960
    - Novartis Investigative Site
  - Menen, Belgium, 8930
    - Novartis Investigative Site
  - Montigny-le-tilleul, Belgium, 6110
    - Novartis Investigative Site
  - Namur, Belgium, 5000
    - Novartis Investigative Site
  - Oostende, Belgium, 8400
    - Novartis Investigative Site
  - Turnhout, Belgium, 2300
    - Novartis Investigative Site
Brazil
- GO
  - Goiania, GO, Brazil, 74605-050
    - Novartis Investigative Site
- MG
  - Juiz de Fora, MG, Brazil, 36036-110
    - Novartis Investigative Site
- RJ
  - Rio de Janeiro, RJ, Brazil, 22271-110
    - Novartis Investigative Site
- RS
  - Caxias do Sul, RS, Brazil, 95070-560
    - Novartis Investigative Site
  - Porto Alegre, RS, Brazil, 90020-090
    - Novartis Investigative Site
  - Porto Alegre, RS, Brazil, 90610-000
    - Novartis Investigative Site
  - Porto Alegre, RS, Brazil, 90880-480
    - Novartis Investigative Site
- SP
  - São Paulo, SP, Brazil, 04023-062
    - Novartis Investigative Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N1
    - Novartis Investigative Site
  - Calgary, Alberta, Canada, T2V 1P9
    - Novartis Investigative Site
  - Edmonton, Alberta, Canada, T6G 2B7
    - Novartis Investigative Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 1E4
    - Novartis Investigative Site
  - Vancouver, British Columbia, Canada, V5Z 3J5
    - Novartis Investigative Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3C 0N2
    - Novartis Investigative Site
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 1A7
    - Novartis Investigative Site
- Ontario
  - Burlington, Ontario, Canada, L7N 3V2
    - Novartis Investigative Site
  - Mississauga, Ontario, Canada, L5B 4A9
    - Novartis Investigative Site
  - Newmarket, Ontario, Canada, L3Y 5G8
    - Novartis Investigative Site
  - Ottawa, Ontario, Canada, K1Y 4G2
    - Novartis Investigative Site
  - Toronto, Ontario, Canada, M6H 3M2
    - Novartis Investigative Site
  - Toronto, Ontario, Canada, M5T 3A9
    - Novartis Investigative Site
  - Toronto, Ontario, Canada, M5G1N8
    - Novartis Investigative Site
- Quebec
  - Montreal, Quebec, Canada, H2L 4M1
    - Novartis Investigative Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Novartis Investigative Site
  - Montreal, Quebec, Canada, H2L 2W5
    - Novartis Investigative Site
  - Montreal, Quebec, Canada, H2X 2P4
    - Novartis Investigative Site
  - Sainte-Foy, Quebec, Canada, G1V 4G5
    - Novartis Investigative Site
  - Sherbrooke, Quebec, Canada, J1H 4J6
    - Novartis Investigative Site
China
- - Beijing, China, 100020
    - Novartis Investigative Site
  - Beijing, China, 100034
    - Novartis Investigative Site
  - Chongqing, China, 400037
    - Novartis Investigative Site
  - Shanghai, China, 200025
    - Novartis Investigative Site
  - Shen Yang, China, 110001
    - Novartis Investigative Site
- Hebei
  - Shijiazhuang, Hebei, China, 050000
    - Novartis Investigative Site
- Hunan
  - Changsha, Hunan, China, 410003
    - Novartis Investigative Site
  - Changsha City, Hunan, China, 410011
    - Novartis Investigative Site
- Liaoning
  - Shengyang, Liaoning, China, 110016
    - Novartis Investigative Site
- Shanxi
  - Xi'an, Shanxi, China, 710032
    - Novartis Investigative Site
  - Xi'an, Shanxi, China, 710061
    - Novartis Investigative Site
Colombia
- - Barranquilla, Colombia
    - Novartis Investigative Site
  - Bogotá, Colombia
    - Novartis Investigative Site
  - Medellín, Colombia
    - Novartis Investigative Site
Costa Rica
- - San Francisco de Asís, Costa Rica
    - Novartis Investigative Site
  - San Jose, Costa Rica
    - Novartis Investigative Site
Czech Republic
- - Beroun, Czech Republic
    - Novartis Investigative Site
  - Ceske Budejovice, Czech Republic, 370 87
    - Novartis Investigative Site
  - Cesky Krumlov, Czech Republic, 381 01
    - Novartis Investigative Site
  - Cvikov, Czech Republic, 471 54
    - Novartis Investigative Site
  - Karlovy Vary, Czech Republic, 360 66
    - Novartis Investigative Site
  - Karlovy Vary, Czech Republic, 360 06
    - Novartis Investigative Site
  - Kurim, Czech Republic, 66434
    - Novartis Investigative Site
  - Novy Jicin, Czech Republic, 741 01
    - Novartis Investigative Site
  - Ostrava, Czech Republic, 70030
    - Novartis Investigative Site
  - Ostrava - Hrabuvka, Czech Republic, 70030
    - Novartis Investigative Site
  - Praha 6, Czech Republic, 169 00
    - Novartis Investigative Site
  - Prerov, Czech Republic, 75000
    - Novartis Investigative Site
  - Rokycany, Czech Republic, 337 22
    - Novartis Investigative Site
  - Rudna, Czech Republic, 25219
    - Novartis Investigative Site
  - Strakonice, Czech Republic, 38601
    - Novartis Investigative Site
  - Teplice, Czech Republic, 415 01
    - Novartis Investigative Site
  - Zatec, Czech Republic, 438 01
    - Novartis Investigative Site
- CZE
  - Kyjov, CZE, Czech Republic, 697 70
    - Novartis Investigative Site
Denmark
- - Aalborg, Denmark, DK-9100
    - Novartis Investigative Site
  - Copenhagen NV, Denmark, DK-2400
    - Novartis Investigative Site
  - Hellerup, Denmark, DK-2900
    - Novartis Investigative Site
  - Helsingor, Denmark, DK-3000
    - Novartis Investigative Site
  - Hvidovre, Denmark, DK-2650
    - Novartis Investigative Site
  - Odense C, Denmark, DK-5000
    - Novartis Investigative Site
  - Århus, Denmark, DK-8000
    - Novartis Investigative Site
Estonia
- - Rakvere, Estonia, 44310
    - Novartis Investigative Site
  - Tallinn, Estonia, 13619
    - Novartis Investigative Site
  - Tartu, Estonia, 51014
    - Novartis Investigative Site
Finland
- - HUS, Finland, 00029
    - Novartis Investigative Site
  - Helsinki, Finland, 00029
    - Novartis Investigative Site
  - Jyvaskyla, Finland, 40100
    - Novartis Investigative Site
  - Pori, Finland, FIN-28500
    - Novartis Investigative Site
  - Porvoo, Finland, FIN-06200
    - Novartis Investigative Site
  - Tampere, Finland, FIN-33521
    - Novartis Investigative Site
  - Turku, Finland, FIN-20100
    - Novartis Investigative Site
France
- - Beuvry, France, 62660
    - Novartis Investigative Site
  - Bourges, France, 18000
    - Novartis Investigative Site
  - Ferolles-Attily, France, 77150
    - Novartis Investigative Site
  - Lyon cedex 04, France, 69317
    - Novartis Investigative Site
  - Montpellier, France, 34059
    - Novartis Investigative Site
  - Nantes, France, 44000
    - Novartis Investigative Site
  - Nice Cedex 1, France, 06602
    - Novartis Investigative Site
  - Ollioules Cedex, France, 83192
    - Novartis Investigative Site
  - Paris, France, 75006
    - Novartis Investigative Site
  - Perpignan Cedex, France, 66025
    - Novartis Investigative Site
  - Pessac, France, 33604
    - Novartis Investigative Site
  - Reims, France, 51092
    - Novartis Investigative Site
  - St Michel, France, 16470
    - Novartis Investigative Site
  - Vandoeuvre les Nancy, France, 54511
    - Novartis Investigative Site
Germany
- - Bad Woerishofen, Germany, 86825
    - Novartis Investigative Site
  - Berlin, Germany, 12043
    - Novartis Investigative Site
  - Berlin, Germany, 12687
    - Novartis Investigative Site
  - Berlin, Germany, 13086
    - Novartis Investigative Site
  - Berlin, Germany, 10367
    - Novartis Investigative Site
  - Berlin, Germany, 14050
    - Novartis Investigative Site
  - Berlin, Germany, 10969
    - Novartis Investigative Site
  - Berlin, Germany, 13581
    - Novartis Investigative Site
  - Berlin, Germany, 13057
    - Novartis Investigative Site
  - Berlin, Germany, 13507
    - Novartis Investigative Site
  - Bonn, Germany, 53119
    - Novartis Investigative Site
  - Bonn, Germany, 53123
    - Novartis Investigative Site
  - Borstel, Germany, 23845
    - Novartis Investigative Site
  - Dachau, Germany, 85221
    - Novartis Investigative Site
  - Euskirchen, Germany, 53879
    - Novartis Investigative Site
  - Frankfurt, Germany, 60596
    - Novartis Investigative Site
  - Fürstenwalde/Spree, Germany, 15517
    - Novartis Investigative Site
  - Güstrow, Germany, 18273
    - Novartis Investigative Site
  - Hamburg, Germany, 20354
    - Novartis Investigative Site
  - Hamburg, Germany, 20357
    - Novartis Investigative Site
  - Hamburg, Germany, 22299
    - Novartis Investigative Site
  - Hamburg, Germany, 22305
    - Novartis Investigative Site
  - Hoyerswerda, Germany, 02977
    - Novartis Investigative Site
  - Landsberg, Germany, 86899
    - Novartis Investigative Site
  - Leipzig, Germany, 04207
    - Novartis Investigative Site
  - Mainz, Germany, D-55101
    - Novartis Investigative Site
  - Marburg, Germany, 35037
    - Novartis Investigative Site
  - Muenchen, Germany, 80331
    - Novartis Investigative Site
  - Muenchen, Germany, 80539
    - Novartis Investigative Site
  - Muenchen, Germany, 81677
    - Novartis Investigative Site
  - Muenchen, Germany, 81243
    - Novartis Investigative Site
  - München, Germany, 80335
    - Novartis Investigative Site
  - Neu-Ulm, Germany, 89231
    - Novartis Investigative Site
  - Neumünster, Germany, 24534
    - Novartis Investigative Site
  - Neuss, Germany, 41462
    - Novartis Investigative Site
  - Oranienburg, Germany, 16515
    - Novartis Investigative Site
  - Radebeul, Germany, 01445
    - Novartis Investigative Site
  - Ratingen, Germany, 40878
    - Novartis Investigative Site
  - Rüdersdorf, Germany, 15562
    - Novartis Investigative Site
  - Teterow, Germany, 17166
    - Novartis Investigative Site
  - Ulm, Germany, 89081
    - Novartis Investigative Site
  - Wedel, Germany, 22880
    - Novartis Investigative Site
  - Witten, Germany, 58452
    - Novartis Investigative Site
Hungary
- - Budapest, Hungary, 1125
    - Novartis Investigative Site
  - Cegled, Hungary, 2700
    - Novartis Investigative Site
  - Debrecen, Hungary, 4032
    - Novartis Investigative Site
  - Deszk, Hungary, 6772
    - Novartis Investigative Site
  - Mosonmagyarovar, Hungary, 9200
    - Novartis Investigative Site
  - Nyiregyhaza, Hungary, 4400
    - Novartis Investigative Site
  - Sopron, Hungary, 9400
    - Novartis Investigative Site
  - Szarvas, Hungary, 5540
    - Novartis Investigative Site
  - Tatabanya, Hungary, 2800
    - Novartis Investigative Site
  - Torokbalint, Hungary, 2045
    - Novartis Investigative Site
Iceland
- - Reykjavik, Iceland, IS-109
    - Novartis Investigative Site
India
- - Nagpur - Maharashtra, India, 440012
    - Novartis Investigative Site
  - Nagpur - Maharastra, India, 400 012
    - Novartis Investigative Site
  - Panjim, India, 403002
    - Novartis Investigative Site
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500004
    - Novartis Investigative Site
  - Hyderabad, Andhra Pradesh, India, 500012
    - Novartis Investigative Site
- Delhi
  - New Delhi, Delhi, India, 110029
    - Novartis Investigative Site
- Gujrat
  - Ahmedabad, Gujrat, India, 380009
    - Novartis Investigative Site
- Gujrat-India
  - Ahmedabad, Gujrat-India, India, 380054
    - Novartis Investigative Site
- Karnataka
  - Bangalore, Karnataka, India, 560002
    - Novartis Investigative Site
  - Bangalore, Karnataka, India, 560 002
    - Novartis Investigative Site
  - Mangalore, Karnataka, India, 575001
    - Novartis Investigative Site
- Kerala
  - Calicut, Kerala, India, 673008
    - Novartis Investigative Site
  - Trivandrum, Kerala, India, 695011
    - Novartis Investigative Site
- Madhya Pradesh
  - Indore, Madhya Pradesh, India, 452001
    - Novartis Investigative Site
- New Delhi
  - Noida, New Delhi, India, 201301
    - Novartis Investigative Site
- Rajasthan
  - Jaipur, Rajasthan, India, 302023
    - Novartis Investigative Site
- Tamil Nadu
  - Coimbatore, Tamil Nadu, India, 641 002
    - Novartis Investigative Site
  - Vellore, Tamil Nadu, India, 632004
    - Novartis Investigative Site
Israel
- - Ashkelon, Israel, 78278
    - Novartis Investigative Site
  - Jerusalem, Israel, 91120
    - Novartis Investigative Site
  - Ramat Gan, Israel, 52621
    - Novartis Investigative Site
  - Rehovot, Israel, 76100
    - Novartis Investigative Site
  - Tel-Aviv, Israel, 64239
    - Novartis Investigative Site
Italy
- - Napoli, Italy, 80131
    - Novartis Investigative Site
  - Pisa, Italy, 56124
    - Novartis Investigative Site
- BA
  - Acquaviva delle Fonti, BA, Italy, 70021
    - Novartis Investigative Site
  - Bari, BA, Italy, 70124
    - Novartis Investigative Site
- BG
  - Bergamo, BG, Italy, 24128
    - Novartis Investigative Site
- BS
  - Brescia, BS, Italy, 25127
    - Novartis Investigative Site
- CZ
  - Catanzaro, CZ, Italy, 88100
    - Novartis Investigative Site
- FE
  - Cona, FE, Italy, 44100
    - Novartis Investigative Site
- FR
  - Cassino, FR, Italy, 03043
    - Novartis Investigative Site
- GE
  - Genova, GE, Italy, 16132
    - Novartis Investigative Site
- MI
  - Milano, MI, Italy, 20142
    - Novartis Investigative Site
  - Milano, MI, Italy, 20126
    - Novartis Investigative Site
  - Milano, MI, Italy, 20157
    - Novartis Investigative Site
- MO
  - Modena, MO, Italy, 41100
    - Novartis Investigative Site
- PA
  - Palermo, PA, Italy, 90146
    - Novartis Investigative Site
- PN
  - Pordenone, PN, Italy, 33170
    - Novartis Investigative Site
- PO
  - Prato, PO, Italy, 59100
    - Novartis Investigative Site
- PR
  - Parma, PR, Italy, 43100
    - Novartis Investigative Site
- RM
  - Roma, RM, Italy, 00168
    - Novartis Investigative Site
  - Roma, RM, Italy, 00161
    - Novartis Investigative Site
  - Roma, RM, Italy, 00133
    - Novartis Investigative Site
  - Roma, RM, Italy, 00163
    - Novartis Investigative Site
- SA
  - Cava Dei Tirreni, SA, Italy, 84013
    - Novartis Investigative Site
- SI
  - Siena, SI, Italy, 53100
    - Novartis Investigative Site
- TE
  - Teramo, TE, Italy, 64100
    - Novartis Investigative Site
- TO
  - Orbassano, TO, Italy, 10043
    - Novartis Investigative Site
- TS
  - Trieste, TS, Italy, 34149
    - Novartis Investigative Site
- VA
  - Cuasso al Monte, VA, Italy, 21050
    - Novartis Investigative Site
- VR
  - Verona, VR, Italy, 37126
    - Novartis Investigative Site
Latvia
- - Riga, Latvia, 1002
    - Novartis Investigative Site
- LV
  - Riga, LV, Latvia, LV-1038
    - Novartis Investigative Site
Lithuania
- - Kaunas, Lithuania, 44320
    - Novartis Investigative Site
  - Klaipeda, Lithuania, LT-92231
    - Novartis Investigative Site
  - Siauliai, Lithuania, LT-76231
    - Novartis Investigative Site
  - Utena, Lithuania, LT-28151
    - Novartis Investigative Site
  - Vilnius, Lithuania, LT-08661
    - Novartis Investigative Site
Mexico
- - San Luis Potosí, Mexico, 78218
    - Novartis Investigative Site
- Hidalgo
  - Pachuca, Hidalgo, Mexico, 42090
    - Novartis Investigative Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - Novartis Investigative Site
  - Guadalajara, Jalisco, Mexico, 44280
    - Novartis Investigative Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64450
    - Novartis Investigative Site
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Novartis Investigative Site
  - Breda, Netherlands, 4819 EV
    - Novartis Investigative Site
  - Eindhoven, Netherlands, 5623 EJ
    - Novartis Investigative Site
  - Enschede, Netherlands, 7513 ER
    - Novartis Investigative Site
  - Rotterdam, Netherlands, 3045 PM
    - Novartis Investigative Site
  - Sneek, Netherlands, 8601 ZK
    - Novartis Investigative Site
  - Zwolle, Netherlands, 8011 JW
    - Novartis Investigative Site
Peru
- Lima
  - Cercado de Lima, Lima, Peru, 01
    - Novartis Investigative Site
  - Jesus Maria, Lima, Peru, 11
    - Novartis Investigative Site
  - La Victoria, Lima, Peru, 13
    - Novartis Investigative Site
  - Miraflores, Lima, Peru, 18
    - Novartis Investigative Site
  - San Borja, Lima, Peru, 41
    - Novartis Investigative Site
  - San Isidro, Lima, Peru, 27
    - Novartis Investigative Site
  - San Martin de Porres, Lima, Peru, 31
    - Novartis Investigative Site
  - San Miguel, Lima, Peru, 32
    - Novartis Investigative Site
  - Santiago de Surco, Lima, Peru, 33
    - Novartis Investigative Site
Philippines
- - Quezon City, Philippines, 1100
    - Novartis Investigative Site
  - Quezon City, Philippines, 1101
    - Novartis Investigative Site
- Metro Manila
  - Quezon City, Metro Manila, Philippines, 1109
    - Novartis Investigative Site
  - Quezon City, Metro Manila, Philippines, 1104
    - Novartis Investigative Site
Poland
- - Gdansk, Poland, 80-169
    - Novartis Investigative Site
  - Gdansk, Poland, 80-847
    - Novartis Investigative Site
  - Katowice, Poland, 40-752
    - Novartis Investigative Site
  - Krakow, Poland, 31-159
    - Novartis Investigative Site
  - Krakow, Poland, 31-202
    - Novartis Investigative Site
  - Krakow, Poland, 31-455
    - Novartis Investigative Site
  - Warszawa, Poland, 02-341
    - Novartis Investigative Site
  - Warszawa, Poland, 01-138
    - Novartis Investigative Site
  - Wroclaw, Poland, 50-044
    - Novartis Investigative Site
Portugal
- - Amadora, Portugal, 2720-276
    - Novartis Investigative Site
  - Coimbra, Portugal, 3000-075
    - Novartis Investigative Site
  - Coimbra, Portugal, 3041-853
    - Novartis Investigative Site
  - Lisboa, Portugal, 1649-035
    - Novartis Investigative Site
  - Lisboa, Portugal, 1169-024
    - Novartis Investigative Site
  - Lisboa, Portugal, 1769-001
    - Novartis Investigative Site
  - Porto, Portugal, 4200-319
    - Novartis Investigative Site
Romania
- - Bucharest, Romania, 060011
    - Novartis Investigative Site
  - Cluj-Napoca, Romania, 400371
    - Novartis Investigative Site
- District 3
  - Bucharest, District 3, Romania, 030303
    - Novartis Investigative Site
- Jud. Brasov
  - Brasov, Jud. Brasov, Romania, 500118
    - Novartis Investigative Site
- Jud. Constanta
  - Constanta, Jud. Constanta, Romania, 900002
    - Novartis Investigative Site
- Jud. Iasi
  - Iasi, Jud. Iasi, Romania, 700115
    - Novartis Investigative Site
Russian Federation
- - Chelyabinsk, Russian Federation, 454021
    - Novartis Investigative Site
  - Chelyabinsk, Russian Federation, 454047
    - Novartis Investigative Site
  - Ekaterinburg, Russian Federation, 620109
    - Novartis Investigative Site
  - Ekaterinburg, Russian Federation, 620219
    - Novartis Investigative Site
  - Kazan, Russian Federation, 420015
    - Novartis Investigative Site
  - Moscow, Russian Federation, 121359
    - Novartis Investigative Site
  - Moscow, Russian Federation, 105229
    - Novartis Investigative Site
  - Moscow, Russian Federation, 119992
    - Novartis Investigative Site
  - Moscow, Russian Federation, 115280
    - Novartis Investigative Site
  - Moscow, Russian Federation, 105077
    - Novartis Investigative Site
  - Moscow, Russian Federation, 115446
    - Novartis Investigative Site
  - Moscow, Russian Federation, 121609
    - Novartis Investigative Site
  - Samara, Russian Federation, 443079
    - Novartis Investigative Site
  - Sankt-Peterburg, Russian Federation, 197022
    - Novartis Investigative Site
  - St. Petersburg, Russian Federation, 194354
    - Novartis Investigative Site
  - St.-Petersburg, Russian Federation, 193231
    - Novartis Investigative Site
- Tatarstan Republic
  - Kazan, Tatarstan Republic, Russian Federation, 420015
    - Novartis Investigative Site
Slovakia
- - Bratislava, Slovakia, 826 06
    - Novartis Investigative Site
  - Kosice, Slovakia, 040 01
    - Novartis Investigative Site
  - Lucenec, Slovakia, 984 39
    - Novartis Investigative Site
  - Nove Zamky, Slovakia, 940 01
    - Novartis Investigative Site
  - Poprad, Slovakia, 058 01
    - Novartis Investigative Site
- Slovak Republic
  - Bratislava, Slovak Republic, Slovakia, 821 06
    - Novartis Investigative Site
  - Kosice, Slovak Republic, Slovakia, 041 90
    - Novartis Investigative Site
  - Spisska Nova Ves, Slovak Republic, Slovakia, 052 01
    - Novartis Investigative Site
South Africa
- - Bloemfontein, South Africa, 9301
    - Novartis Investigative Site
  - Bloemfontein, South Africa, 9317
    - Novartis Investigative Site
  - Cape Town, South Africa, 8001
    - Novartis Investigative Site
  - Durban, South Africa, 4001
    - Novartis Investigative Site
Spain
- - Madrid, Spain, 28007
    - Novartis Investigative Site
  - Madrid, Spain, 28040
    - Novartis Investigative Site
- Andalucia
  - Jerez de La Frontera, Andalucia, Spain, 11407
    - Novartis Investigative Site
  - Malaga, Andalucia, Spain, 29010
    - Novartis Investigative Site
  - Sanlúcar de Barrameda, Andalucia, Spain, 11540
    - Novartis Investigative Site
  - Sevilla, Andalucia, Spain, 41009
    - Novartis Investigative Site
- Asturias
  - Gijon, Asturias, Spain, 33290
    - Novartis Investigative Site
- Castilla la Mancha
  - Illescas, Castilla la Mancha, Spain, 45200
    - Novartis Investigative Site
- Castilla y Leon
  - Valladolid, Castilla y Leon, Spain, 47011
    - Novartis Investigative Site
- Cataluña
  - Barcelona, Cataluña, Spain, 08003
    - Novartis Investigative Site
  - Barcelona, Cataluña, Spain, 08041
    - Novartis Investigative Site
  - Barcelona, Cataluña, Spain, 08036
    - Novartis Investigative Site
  - Salt, Cataluña, Spain, 17190
    - Novartis Investigative Site
  - Sant Boi de Llobregat, Cataluña, Spain, 08830
    - Novartis Investigative Site
  - Terrassa, Cataluña, Spain, 08221
    - Novartis Investigative Site
  - Vic, Cataluña, Spain, 08500
    - Novartis Investigative Site
- Comunidad Valenciana
  - Alicante, Comunidad Valenciana, Spain, 03114
    - Novartis Investigative Site
  - Alzira, Comunidad Valenciana, Spain, 46600
    - Novartis Investigative Site
  - Requena, Comunidad Valenciana, Spain, 46340
    - Novartis Investigative Site
- Extremadura
  - Caceres, Extremadura, Spain, 10003
    - Novartis Investigative Site
  - Mérida, Extremadura, Spain, 06800
    - Novartis Investigative Site
  - Plasencia, Extremadura, Spain, 10600
    - Novartis Investigative Site
- Galicia
  - La Coruna, Galicia, Spain, 15006
    - Novartis Investigative Site
  - Lugo, Galicia, Spain, 27003
    - Novartis Investigative Site
  - Santiago de Compostela, Galicia, Spain, 15706
    - Novartis Investigative Site
- Madrid
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Novartis Investigative Site
Sweden
- - Göteborg, Sweden, 413 45
    - Novartis Investigative Site
  - Göteborg, Sweden, 412 63
    - Novartis Investigative Site
  - Luleå, Sweden, SE-971 80
    - Novartis Investigative Site
  - Lund, Sweden, SE-221 85
    - Novartis Investigative Site
  - Malmö, Sweden, 205 02
    - Novartis Investigative Site
  - Skellefteå, Sweden, SE 931 32
    - Novartis Investigative Site
  - Stockholm, Sweden, S-171 76
    - Novartis Investigative Site
  - Sundsvall, Sweden, 851 86
    - Novartis Investigative Site
Switzerland
- - Bern, Switzerland, 3013
    - Novartis Investigative Site
  - Crans-Montana, Switzerland, 3963
    - Novartis Investigative Site
  - Lausanne, Switzerland, 1011
    - Novartis Investigative Site
  - St. Gallen, Switzerland, 9007
    - Novartis Investigative Site
  - Thun, Switzerland, 3600
    - Novartis Investigative Site
  - Winterthur, Switzerland, 8401
    - Novartis Investigative Site
  - Zuerich, Switzerland, 8032
    - Novartis Investigative Site
- ZH
  - Faltigberg-Wald, ZH, Switzerland, 8639
    - Novartis Investigative Site
Taiwan
- - Taichung, Taiwan, 40447
    - Novartis Investigative Site
  - Taichung, Taiwan, 40705
    - Novartis Investigative Site
  - Taipei, Taiwan, 10002
    - Novartis Investigative Site
  - Taipei, Taiwan, 110
    - Novartis Investigative Site
  - Taipei County, Taiwan
    - Novartis Investigative Site
Thailand
- - Bangkok, Thailand, 10700
    - Novartis Investigative Site
  - Chiang Mai, Thailand, 50200
    - Novartis Investigative Site
  - Khon Kaen, Thailand, 40002
    - Novartis Investigative Site
  - Songkla, Thailand, 90110
    - Novartis Investigative Site
Turkey
- - Ankara, Turkey, 06100
    - Novartis Investigative Site
  - Canakkale, Turkey, 17100
    - Novartis Investigative Site
  - Diskapi / Ankara, Turkey, 06110
    - Novartis Investigative Site
  - Emek / Ankara, Turkey, 06510
    - Novartis Investigative Site
  - Gaziantep, Turkey, 27070
    - Novartis Investigative Site
  - Isparta, Turkey, 32100
    - Novartis Investigative Site
  - Istanbul, Turkey
    - Novartis Investigative Site
  - Izmir, Turkey, 35340
    - Novartis Investigative Site
  - Kahramanmaras, Turkey, 46100
    - Novartis Investigative Site
  - Kecioren / Ankara, Turkey, 06280
    - Novartis Investigative Site
  - Kozlu / Zonguldak, Turkey, 67600
    - Novartis Investigative Site
  - Malatya, Turkey, 44280
    - Novartis Investigative Site
  - Mersin, Turkey, 33079
    - Novartis Investigative Site
  - Yenisehir/Izmir, Turkey, 35110
    - Novartis Investigative Site
United Kingdom
- - Belfast, United Kingdom, BT7 2BE
    - Novartis Investigative Site
  - Bexhill-on-Sea, United Kingdom, TN40 1JJ
    - Novartis Investigative Site
  - Bradford, United Kingdom, BD9 6RJ
    - Novartis Investigative Site
  - Bristol, United Kingdom, BS10 5NB
    - Novartis Investigative Site
  - Cambridge, United Kingdom, CB7 5JD
    - Novartis Investigative Site
  - Lancashire, United Kingdom, FY3 7EN
    - Novartis Investigative Site
  - Lancashire, United Kingdom, B13 6TL
    - Novartis Investigative Site
  - Liverpool, United Kingdom, L9 7AL
    - Novartis Investigative Site
  - London, United Kingdom, SW3 6PH
    - Novartis Investigative Site
  - London, United Kingdom, E2 9JX
    - Novartis Investigative Site
  - London, United Kingdom, W1G 8HU
    - Novartis Investigative Site
  - Newport, United Kingdom, P030 5TG
    - Novartis Investigative Site
  - Stockport, United Kingdom, SK4 4NX
    - Novartis Investigative Site
  - Stockport, United Kingdom, SK8 6LU
    - Novartis Investigative Site
  - Surrey, United Kingdom, KT16 0PZ
    - Novartis Investigative Site
  - Warminster, United Kingdom, BA12 9AA
    - Novartis Investigative Site
  - Watford, United Kingdom, WD25 0EA
    - Novartis Investigative Site
  - Windsor, United Kingdom, SL4 3DP
    - Novartis Investigative Site
- England
  - Swansea, England, United Kingdom, SA6 6NL
    - Novartis Investigative Site
- Newcastle
  - Newcastle Upon Tyne, Newcastle, United Kingdom, NE7 7DN
    - Novartis Investigative Site
- Surrey
  - Ash Vale, Surrey, United Kingdom, GU12 5BA
    - Novartis Investigative Site
- West Sussex
  - Crawley, West Sussex, United Kingdom, RH10 7DX
    - Novartis Investigative Site
Venezuela
- Estado Carabobo
  - Valencia, Estado Carabobo, Venezuela, 2005
    - Novartis Investigative Site
- Estado Lara
  - Barquisimeto, Estado Lara, Venezuela, 3002
    - Novartis Investigative Site
- Estado Zulia
  - Maracaibo, Estado Zulia, Venezuela, 4002
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
1. Smoking history of at least 10 pack years, both current and ex-smokers are eligible
2. A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Exclusion Criteria:

Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indacaterol Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)	Drug: Indacaterol 150 µg Indacaterol 150 µg o.d. delivered via SDDPI
Active Comparator: Tiotropium Tiotropium 18 µg o.d. delivered via the handihaler®	Drug: Tiotropium Tiotropium 18 µg o.d. delivered via handihaler®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1). Time Frame: 12 weeks	The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of COPD Exacerbations Time Frame: 52 weeks	COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.	52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, Cameron R, Shoaib M, Lawrence D, Young D, McBryan D; INVIGORATE investigators. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013 Sep;1(7):524-33. doi: 10.1016/S2213-2600(13)70158-9. Epub 2013 Aug 21.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 15, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CQAB149B2348
2008-007944-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Exacerbation Study (INVIGORATE)

A Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Indacaterol 150 µg

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