Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Exacerbation Study (INVIGORATE)

16. september 2013 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3439

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
      • Tauranga, New Zealand, Australien, 3001
        • Novartis Investigative Site
    • New South Wales
      • Bankstown, New South Wales, Australien, 2200
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Novartis Investigative Site
      • Daw Park, South Australia, Australien, 5041
        • Novartis Investigative Site
    • Victoria
      • Heidelberg, Victoria, Australien, 3084
        • Novartis Investigative Site
      • Parkville, Victoria, Australien, 3050
        • Novartis Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Novartis Investigative Site
  • Belgien
      • Aalst, Belgien, 9300
        • Novartis Investigative Site
      • Antwerpen, Belgien, 2020
        • Novartis Investigative Site
      • Bruxelles, Belgien, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgien, 1000
        • Novartis Investigative Site
      • Duffel, Belgien, 2570
        • Novartis Investigative Site
      • Eupen, Belgien, 4700
        • Novartis Investigative Site
      • Framerie, Belgien, 7080
        • Novartis Investigative Site
      • Geraardsbergen, Belgien, 9500
        • Novartis Investigative Site
      • Gilly, Belgien, 6060
        • Novartis Investigative Site
      • Godinne, Belgien, 5530
        • Novartis Investigative Site
      • Gozée, Belgien, 6534
        • Novartis Investigative Site
      • Herentals, Belgien, 2200
        • Novartis Investigative Site
      • Jambes, Belgien, 5100
        • Novartis Investigative Site
      • Jette, Belgien, 1090
        • Novartis Investigative Site
      • Kortrijk, Belgien, 8500
        • Novartis Investigative Site
      • Leuven, Belgien, 3000
        • Novartis Investigative Site
      • Liege, Belgien, 4000
        • Novartis Investigative Site
      • Liège, Belgien, 4000
        • Novartis Investigative Site
      • Malmedy, Belgien, 4960
        • Novartis Investigative Site
      • Menen, Belgien, 8930
        • Novartis Investigative Site
      • Montigny-le-tilleul, Belgien, 6110
        • Novartis Investigative Site
      • Namur, Belgien, 5000
        • Novartis Investigative Site
      • Oostende, Belgien, 8400
        • Novartis Investigative Site
      • Turnhout, Belgien, 2300
        • Novartis Investigative Site
  • Brasilien
    • GO
      • Goiania, GO, Brasilien, 74605-050
        • Novartis Investigative Site
    • MG
      • Juiz de Fora, MG, Brasilien, 36036-110
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brasilien, 22271-110
        • Novartis Investigative Site
    • RS
      • Caxias do Sul, RS, Brasilien, 95070-560
        • Novartis Investigative Site
      • Porto Alegre, RS, Brasilien, 90020-090
        • Novartis Investigative Site
      • Porto Alegre, RS, Brasilien, 90610-000
        • Novartis Investigative Site
      • Porto Alegre, RS, Brasilien, 90880-480
        • Novartis Investigative Site
    • SP
      • São Paulo, SP, Brasilien, 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
  • 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
  • Danmark
      • Aalborg, Danmark, DK-9100
        • Novartis Investigative Site
      • Copenhagen NV, Danmark, DK-2400
        • Novartis Investigative Site
      • Hellerup, Danmark, DK-2900
        • Novartis Investigative Site
      • Helsingor, Danmark, DK-3000
        • Novartis Investigative Site
      • Hvidovre, Danmark, DK-2650
        • Novartis Investigative Site
      • Odense C, Danmark, DK-5000
        • Novartis Investigative Site
      • Århus, Danmark, DK-8000
        • Novartis Investigative Site
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation, 454021
        • Novartis Investigative Site
      • Chelyabinsk, Den Russiske Føderation, 454047
        • Novartis Investigative Site
      • Ekaterinburg, Den Russiske Føderation, 620109
        • Novartis Investigative Site
      • Ekaterinburg, Den Russiske Føderation, 620219
        • Novartis Investigative Site
      • Kazan, Den Russiske Føderation, 420015
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 121359
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 105229
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 119992
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 115280
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 105077
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 115446
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 121609
        • Novartis Investigative Site
      • Samara, Den Russiske Føderation, 443079
        • Novartis Investigative Site
      • Sankt-Peterburg, Den Russiske Føderation, 197022
        • Novartis Investigative Site
      • St. Petersburg, Den Russiske Føderation, 194354
        • Novartis Investigative Site
      • St.-Petersburg, Den Russiske Føderation, 193231
        • Novartis Investigative Site
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Den Russiske Føderation, 420015
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • Belfast, Det Forenede Kongerige, BT7 2BE
        • Novartis Investigative Site
      • Bexhill-on-Sea, Det Forenede Kongerige, TN40 1JJ
        • Novartis Investigative Site
      • Bradford, Det Forenede Kongerige, BD9 6RJ
        • Novartis Investigative Site
      • Bristol, Det Forenede Kongerige, BS10 5NB
        • Novartis Investigative Site
      • Cambridge, Det Forenede Kongerige, CB7 5JD
        • Novartis Investigative Site
      • Lancashire, Det Forenede Kongerige, FY3 7EN
        • Novartis Investigative Site
      • Lancashire, Det Forenede Kongerige, B13 6TL
        • Novartis Investigative Site
      • Liverpool, Det Forenede Kongerige, L9 7AL
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, SW3 6PH
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, E2 9JX
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, W1G 8HU
        • Novartis Investigative Site
      • Newport, Det Forenede Kongerige, P030 5TG
        • Novartis Investigative Site
      • Stockport, Det Forenede Kongerige, SK4 4NX
        • Novartis Investigative Site
      • Stockport, Det Forenede Kongerige, SK8 6LU
        • Novartis Investigative Site
      • Surrey, Det Forenede Kongerige, KT16 0PZ
        • Novartis Investigative Site
      • Warminster, Det Forenede Kongerige, BA12 9AA
        • Novartis Investigative Site
      • Watford, Det Forenede Kongerige, WD25 0EA
        • Novartis Investigative Site
      • Windsor, Det Forenede Kongerige, SL4 3DP
        • Novartis Investigative Site
    • England
      • Swansea, England, Det Forenede Kongerige, SA6 6NL
        • Novartis Investigative Site
    • Newcastle
      • Newcastle Upon Tyne, Newcastle, Det Forenede Kongerige, NE7 7DN
        • Novartis Investigative Site
    • Surrey
      • Ash Vale, Surrey, Det Forenede Kongerige, GU12 5BA
        • Novartis Investigative Site
    • West Sussex
      • Crawley, West Sussex, Det Forenede Kongerige, RH10 7DX
        • Novartis Investigative Site
  • Estland
      • Rakvere, Estland, 44310
        • Novartis Investigative Site
      • Tallinn, Estland, 13619
        • Novartis Investigative Site
      • Tartu, Estland, 51014
        • Novartis Investigative Site
  • Filippinerne
      • Quezon City, Filippinerne, 1100
        • Novartis Investigative Site
      • Quezon City, Filippinerne, 1101
        • Novartis Investigative Site
    • Metro Manila
      • Quezon City, Metro Manila, Filippinerne, 1109
        • Novartis Investigative Site
      • Quezon City, Metro Manila, Filippinerne, 1104
        • 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
  • Frankrig
      • Beuvry, Frankrig, 62660
        • Novartis Investigative Site
      • Bourges, Frankrig, 18000
        • Novartis Investigative Site
      • Ferolles-Attily, Frankrig, 77150
        • Novartis Investigative Site
      • Lyon cedex 04, Frankrig, 69317
        • Novartis Investigative Site
      • Montpellier, Frankrig, 34059
        • Novartis Investigative Site
      • Nantes, Frankrig, 44000
        • Novartis Investigative Site
      • Nice Cedex 1, Frankrig, 06602
        • Novartis Investigative Site
      • Ollioules Cedex, Frankrig, 83192
        • Novartis Investigative Site
      • Paris, Frankrig, 75006
        • Novartis Investigative Site
      • Perpignan Cedex, Frankrig, 66025
        • Novartis Investigative Site
      • Pessac, Frankrig, 33604
        • Novartis Investigative Site
      • Reims, Frankrig, 51092
        • Novartis Investigative Site
      • St Michel, Frankrig, 16470
        • Novartis Investigative Site
      • Vandoeuvre les Nancy, Frankrig, 54511
        • Novartis Investigative Site
  • Holland
      • Almelo, Holland, 7609 PP
        • Novartis Investigative Site
      • Breda, Holland, 4819 EV
        • Novartis Investigative Site
      • Eindhoven, Holland, 5623 EJ
        • Novartis Investigative Site
      • Enschede, Holland, 7513 ER
        • Novartis Investigative Site
      • Rotterdam, Holland, 3045 PM
        • Novartis Investigative Site
      • Sneek, Holland, 8601 ZK
        • Novartis Investigative Site
      • Zwolle, Holland, 8011 JW
        • Novartis Investigative Site
  • Indien
      • Nagpur - Maharashtra, Indien, 440012
        • Novartis Investigative Site
      • Nagpur - Maharastra, Indien, 400 012
        • Novartis Investigative Site
      • Panjim, Indien, 403002
        • Novartis Investigative Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indien, 500004
        • Novartis Investigative Site
      • Hyderabad, Andhra Pradesh, Indien, 500012
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, Indien, 110029
        • Novartis Investigative Site
    • Gujrat
      • Ahmedabad, Gujrat, Indien, 380009
        • Novartis Investigative Site
    • Gujrat-India
      • Ahmedabad, Gujrat-India, Indien, 380054
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, Indien, 560002
        • Novartis Investigative Site
      • Bangalore, Karnataka, Indien, 560 002
        • Novartis Investigative Site
      • Mangalore, Karnataka, Indien, 575001
        • Novartis Investigative Site
    • Kerala
      • Calicut, Kerala, Indien, 673008
        • Novartis Investigative Site
      • Trivandrum, Kerala, Indien, 695011
        • Novartis Investigative Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, Indien, 452001
        • Novartis Investigative Site
    • New Delhi
      • Noida, New Delhi, Indien, 201301
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, Indien, 302023
        • Novartis Investigative Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Indien, 641 002
        • Novartis Investigative Site
      • Vellore, Tamil Nadu, Indien, 632004
        • Novartis Investigative Site
  • Island
      • Reykjavik, Island, IS-109
        • 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
  • Italien
      • Napoli, Italien, 80131
        • Novartis Investigative Site
      • Pisa, Italien, 56124
        • Novartis Investigative Site
    • BA
      • Acquaviva delle Fonti, BA, Italien, 70021
        • Novartis Investigative Site
      • Bari, BA, Italien, 70124
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italien, 24128
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italien, 25127
        • Novartis Investigative Site
    • CZ
      • Catanzaro, CZ, Italien, 88100
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italien, 44100
        • Novartis Investigative Site
    • FR
      • Cassino, FR, Italien, 03043
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italien, 16132
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italien, 20142
        • Novartis Investigative Site
      • Milano, MI, Italien, 20126
        • Novartis Investigative Site
      • Milano, MI, Italien, 20157
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italien, 41100
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italien, 90146
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italien, 33170
        • Novartis Investigative Site
    • PO
      • Prato, PO, Italien, 59100
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italien, 43100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italien, 00168
        • Novartis Investigative Site
      • Roma, RM, Italien, 00161
        • Novartis Investigative Site
      • Roma, RM, Italien, 00133
        • Novartis Investigative Site
      • Roma, RM, Italien, 00163
        • Novartis Investigative Site
    • SA
      • Cava Dei Tirreni, SA, Italien, 84013
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italien, 53100
        • Novartis Investigative Site
    • TE
      • Teramo, TE, Italien, 64100
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italien, 10043
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italien, 34149
        • Novartis Investigative Site
    • VA
      • Cuasso al Monte, VA, Italien, 21050
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italien, 37126
        • Novartis Investigative Site
  • Kalkun
      • Ankara, Kalkun, 06100
        • Novartis Investigative Site
      • Canakkale, Kalkun, 17100
        • Novartis Investigative Site
      • Diskapi / Ankara, Kalkun, 06110
        • Novartis Investigative Site
      • Emek / Ankara, Kalkun, 06510
        • Novartis Investigative Site
      • Gaziantep, Kalkun, 27070
        • Novartis Investigative Site
      • Isparta, Kalkun, 32100
        • Novartis Investigative Site
      • Istanbul, Kalkun
        • Novartis Investigative Site
      • Izmir, Kalkun, 35340
        • Novartis Investigative Site
      • Kahramanmaras, Kalkun, 46100
        • Novartis Investigative Site
      • Kecioren / Ankara, Kalkun, 06280
        • Novartis Investigative Site
      • Kozlu / Zonguldak, Kalkun, 67600
        • Novartis Investigative Site
      • Malatya, Kalkun, 44280
        • Novartis Investigative Site
      • Mersin, Kalkun, 33079
        • Novartis Investigative Site
      • Yenisehir/Izmir, Kalkun, 35110
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100020
        • Novartis Investigative Site
      • Beijing, Kina, 100034
        • Novartis Investigative Site
      • Chongqing, Kina, 400037
        • Novartis Investigative Site
      • Shanghai, Kina, 200025
        • Novartis Investigative Site
      • Shen Yang, Kina, 110001
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050000
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, Kina, 410003
        • Novartis Investigative Site
      • Changsha City, Hunan, Kina, 410011
        • Novartis Investigative Site
    • Liaoning
      • Shengyang, Liaoning, Kina, 110016
        • Novartis Investigative Site
    • Shanxi
      • Xi'an, Shanxi, Kina, 710032
        • Novartis Investigative Site
      • Xi'an, Shanxi, Kina, 710061
        • Novartis Investigative Site
  • Letland
      • Riga, Letland, 1002
        • Novartis Investigative Site
    • LV
      • Riga, LV, Letland, LV-1038
        • Novartis Investigative Site
  • Litauen
      • Kaunas, Litauen, 44320
        • Novartis Investigative Site
      • Klaipeda, Litauen, LT-92231
        • Novartis Investigative Site
      • Siauliai, Litauen, LT-76231
        • Novartis Investigative Site
      • Utena, Litauen, LT-28151
        • Novartis Investigative Site
      • Vilnius, Litauen, 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
  • 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
  • Polen
      • Gdansk, Polen, 80-169
        • Novartis Investigative Site
      • Gdansk, Polen, 80-847
        • Novartis Investigative Site
      • Katowice, Polen, 40-752
        • Novartis Investigative Site
      • Krakow, Polen, 31-159
        • Novartis Investigative Site
      • Krakow, Polen, 31-202
        • Novartis Investigative Site
      • Krakow, Polen, 31-455
        • Novartis Investigative Site
      • Warszawa, Polen, 02-341
        • Novartis Investigative Site
      • Warszawa, Polen, 01-138
        • Novartis Investigative Site
      • Wroclaw, Polen, 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
  • Rumænien
      • Bucharest, Rumænien, 060011
        • Novartis Investigative Site
      • Cluj-Napoca, Rumænien, 400371
        • Novartis Investigative Site
    • District 3
      • Bucharest, District 3, Rumænien, 030303
        • Novartis Investigative Site
    • Jud. Brasov
      • Brasov, Jud. Brasov, Rumænien, 500118
        • Novartis Investigative Site
    • Jud. Constanta
      • Constanta, Jud. Constanta, Rumænien, 900002
        • Novartis Investigative Site
    • Jud. Iasi
      • Iasi, Jud. Iasi, Rumænien, 700115
        • Novartis Investigative Site
  • Schweiz
      • Bern, Schweiz, 3013
        • Novartis Investigative Site
      • Crans-Montana, Schweiz, 3963
        • Novartis Investigative Site
      • Lausanne, Schweiz, 1011
        • Novartis Investigative Site
      • St. Gallen, Schweiz, 9007
        • Novartis Investigative Site
      • Thun, Schweiz, 3600
        • Novartis Investigative Site
      • Winterthur, Schweiz, 8401
        • Novartis Investigative Site
      • Zuerich, Schweiz, 8032
        • Novartis Investigative Site
    • ZH
      • Faltigberg-Wald, ZH, Schweiz, 8639
        • Novartis Investigative Site
  • Slovakiet
      • Bratislava, Slovakiet, 826 06
        • Novartis Investigative Site
      • Kosice, Slovakiet, 040 01
        • Novartis Investigative Site
      • Lucenec, Slovakiet, 984 39
        • Novartis Investigative Site
      • Nove Zamky, Slovakiet, 940 01
        • Novartis Investigative Site
      • Poprad, Slovakiet, 058 01
        • Novartis Investigative Site
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakiet, 821 06
        • Novartis Investigative Site
      • Kosice, Slovak Republic, Slovakiet, 041 90
        • Novartis Investigative Site
      • Spisska Nova Ves, Slovak Republic, Slovakiet, 052 01
        • Novartis Investigative Site
  • Spanien
      • Madrid, Spanien, 28007
        • Novartis Investigative Site
      • Madrid, Spanien, 28040
        • Novartis Investigative Site
    • Andalucia
      • Jerez de La Frontera, Andalucia, Spanien, 11407
        • Novartis Investigative Site
      • Malaga, Andalucia, Spanien, 29010
        • Novartis Investigative Site
      • Sanlúcar de Barrameda, Andalucia, Spanien, 11540
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spanien, 41009
        • Novartis Investigative Site
    • Asturias
      • Gijon, Asturias, Spanien, 33290
        • Novartis Investigative Site
    • Castilla la Mancha
      • Illescas, Castilla la Mancha, Spanien, 45200
        • Novartis Investigative Site
    • Castilla y Leon
      • Valladolid, Castilla y Leon, Spanien, 47011
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spanien, 08003
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spanien, 08041
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spanien, 08036
        • Novartis Investigative Site
      • Salt, Cataluña, Spanien, 17190
        • Novartis Investigative Site
      • Sant Boi de Llobregat, Cataluña, Spanien, 08830
        • Novartis Investigative Site
      • Terrassa, Cataluña, Spanien, 08221
        • Novartis Investigative Site
      • Vic, Cataluña, Spanien, 08500
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spanien, 03114
        • Novartis Investigative Site
      • Alzira, Comunidad Valenciana, Spanien, 46600
        • Novartis Investigative Site
      • Requena, Comunidad Valenciana, Spanien, 46340
        • Novartis Investigative Site
    • Extremadura
      • Caceres, Extremadura, Spanien, 10003
        • Novartis Investigative Site
      • Mérida, Extremadura, Spanien, 06800
        • Novartis Investigative Site
      • Plasencia, Extremadura, Spanien, 10600
        • Novartis Investigative Site
    • Galicia
      • La Coruna, Galicia, Spanien, 15006
        • Novartis Investigative Site
      • Lugo, Galicia, Spanien, 27003
        • Novartis Investigative Site
      • Santiago de Compostela, Galicia, Spanien, 15706
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spanien, 28223
        • Novartis Investigative Site
  • Sverige
      • Göteborg, Sverige, 413 45
        • Novartis Investigative Site
      • Göteborg, Sverige, 412 63
        • Novartis Investigative Site
      • Luleå, Sverige, SE-971 80
        • Novartis Investigative Site
      • Lund, Sverige, SE-221 85
        • Novartis Investigative Site
      • Malmö, Sverige, 205 02
        • Novartis Investigative Site
      • Skellefteå, Sverige, SE 931 32
        • Novartis Investigative Site
      • Stockholm, Sverige, S-171 76
        • Novartis Investigative Site
      • Sundsvall, Sverige, 851 86
        • Novartis Investigative Site
  • Sydafrika
      • Bloemfontein, Sydafrika, 9301
        • Novartis Investigative Site
      • Bloemfontein, Sydafrika, 9317
        • Novartis Investigative Site
      • Cape Town, Sydafrika, 8001
        • Novartis Investigative Site
      • Durban, Sydafrika, 4001
        • 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
  • Tjekkiet
      • Beroun, Tjekkiet
        • Novartis Investigative Site
      • Ceske Budejovice, Tjekkiet, 370 87
        • Novartis Investigative Site
      • Cesky Krumlov, Tjekkiet, 381 01
        • Novartis Investigative Site
      • Cvikov, Tjekkiet, 471 54
        • Novartis Investigative Site
      • Karlovy Vary, Tjekkiet, 360 66
        • Novartis Investigative Site
      • Karlovy Vary, Tjekkiet, 360 06
        • Novartis Investigative Site
      • Kurim, Tjekkiet, 66434
        • Novartis Investigative Site
      • Novy Jicin, Tjekkiet, 741 01
        • Novartis Investigative Site
      • Ostrava, Tjekkiet, 70030
        • Novartis Investigative Site
      • Ostrava - Hrabuvka, Tjekkiet, 70030
        • Novartis Investigative Site
      • Praha 6, Tjekkiet, 169 00
        • Novartis Investigative Site
      • Prerov, Tjekkiet, 75000
        • Novartis Investigative Site
      • Rokycany, Tjekkiet, 337 22
        • Novartis Investigative Site
      • Rudna, Tjekkiet, 25219
        • Novartis Investigative Site
      • Strakonice, Tjekkiet, 38601
        • Novartis Investigative Site
      • Teplice, Tjekkiet, 415 01
        • Novartis Investigative Site
      • Zatec, Tjekkiet, 438 01
        • Novartis Investigative Site
    • CZE
      • Kyjov, CZE, Tjekkiet, 697 70
        • Novartis Investigative Site
  • Tyskland
      • Bad Woerishofen, Tyskland, 86825
        • Novartis Investigative Site
      • Berlin, Tyskland, 12043
        • Novartis Investigative Site
      • Berlin, Tyskland, 12687
        • Novartis Investigative Site
      • Berlin, Tyskland, 13086
        • Novartis Investigative Site
      • Berlin, Tyskland, 10367
        • Novartis Investigative Site
      • Berlin, Tyskland, 14050
        • Novartis Investigative Site
      • Berlin, Tyskland, 10969
        • Novartis Investigative Site
      • Berlin, Tyskland, 13581
        • Novartis Investigative Site
      • Berlin, Tyskland, 13057
        • Novartis Investigative Site
      • Berlin, Tyskland, 13507
        • Novartis Investigative Site
      • Bonn, Tyskland, 53119
        • Novartis Investigative Site
      • Bonn, Tyskland, 53123
        • Novartis Investigative Site
      • Borstel, Tyskland, 23845
        • Novartis Investigative Site
      • Dachau, Tyskland, 85221
        • Novartis Investigative Site
      • Euskirchen, Tyskland, 53879
        • Novartis Investigative Site
      • Frankfurt, Tyskland, 60596
        • Novartis Investigative Site
      • Fürstenwalde/Spree, Tyskland, 15517
        • Novartis Investigative Site
      • Güstrow, Tyskland, 18273
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20354
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20357
        • Novartis Investigative Site
      • Hamburg, Tyskland, 22299
        • Novartis Investigative Site
      • Hamburg, Tyskland, 22305
        • Novartis Investigative Site
      • Hoyerswerda, Tyskland, 02977
        • Novartis Investigative Site
      • Landsberg, Tyskland, 86899
        • Novartis Investigative Site
      • Leipzig, Tyskland, 04207
        • Novartis Investigative Site
      • Mainz, Tyskland, D-55101
        • Novartis Investigative Site
      • Marburg, Tyskland, 35037
        • Novartis Investigative Site
      • Muenchen, Tyskland, 80331
        • Novartis Investigative Site
      • Muenchen, Tyskland, 80539
        • Novartis Investigative Site
      • Muenchen, Tyskland, 81677
        • Novartis Investigative Site
      • Muenchen, Tyskland, 81243
        • Novartis Investigative Site
      • München, Tyskland, 80335
        • Novartis Investigative Site
      • Neu-Ulm, Tyskland, 89231
        • Novartis Investigative Site
      • Neumünster, Tyskland, 24534
        • Novartis Investigative Site
      • Neuss, Tyskland, 41462
        • Novartis Investigative Site
      • Oranienburg, Tyskland, 16515
        • Novartis Investigative Site
      • Radebeul, Tyskland, 01445
        • Novartis Investigative Site
      • Ratingen, Tyskland, 40878
        • Novartis Investigative Site
      • Rüdersdorf, Tyskland, 15562
        • Novartis Investigative Site
      • Teterow, Tyskland, 17166
        • Novartis Investigative Site
      • Ulm, Tyskland, 89081
        • Novartis Investigative Site
      • Wedel, Tyskland, 22880
        • Novartis Investigative Site
      • Witten, Tyskland, 58452
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1125
        • Novartis Investigative Site
      • Cegled, Ungarn, 2700
        • Novartis Investigative Site
      • Debrecen, Ungarn, 4032
        • Novartis Investigative Site
      • Deszk, Ungarn, 6772
        • Novartis Investigative Site
      • Mosonmagyarovar, Ungarn, 9200
        • Novartis Investigative Site
      • Nyiregyhaza, Ungarn, 4400
        • Novartis Investigative Site
      • Sopron, Ungarn, 9400
        • Novartis Investigative Site
      • Szarvas, Ungarn, 5540
        • Novartis Investigative Site
      • Tatabanya, Ungarn, 2800
        • Novartis Investigative Site
      • Torokbalint, Ungarn, 2045
        • 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
  • Østrig
      • Feldbach, Østrig, 8330
        • Novartis Investigative Site
      • Grieskirchen, Østrig, 4710
        • Novartis Investigative Site
      • Gänserndorf, Østrig, 2230
        • Novartis Investigative Site
      • Hallein, Østrig, 5400
        • Novartis Investigative Site
      • Linz, Østrig, 4020
        • Novartis Investigative Site
      • Perg, Østrig, 4320
        • Novartis Investigative Site
      • Zwettl, Østrig, 3910
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Indacaterol
Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Medicin: Indacaterol 150 µg
Indacaterol 150 µg o.d. delivered via SDDPI
Aktiv komparator: Tiotropium
Tiotropium 18 µg o.d. delivered via the handihaler®
Medicin: Tiotropium
Tiotropium 18 µg o.d. delivered via handihaler®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trough Forced Expiratory Volume in 1 Second (FEV1).
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of COPD Exacerbations
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2009

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først indsendt

15. februar 2009

Først indsendt, der opfyldte QC-kriterier

17. februar 2009

Først opslået (Skøn)

18. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CQAB149B2348
  • 2008-007944-33

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Indacaterol 150 µg

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lithuania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner