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Exacerbation Study (INVIGORATE)

16. september 2013 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

3439

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • 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
  • Belgia
      • Aalst, Belgia, 9300
        • Novartis Investigative Site
      • Antwerpen, Belgia, 2020
        • Novartis Investigative Site
      • Bruxelles, Belgia, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgia, 1000
        • Novartis Investigative Site
      • Duffel, Belgia, 2570
        • Novartis Investigative Site
      • Eupen, Belgia, 4700
        • Novartis Investigative Site
      • Framerie, Belgia, 7080
        • Novartis Investigative Site
      • Geraardsbergen, Belgia, 9500
        • Novartis Investigative Site
      • Gilly, Belgia, 6060
        • Novartis Investigative Site
      • Godinne, Belgia, 5530
        • Novartis Investigative Site
      • Gozée, Belgia, 6534
        • Novartis Investigative Site
      • Herentals, Belgia, 2200
        • Novartis Investigative Site
      • Jambes, Belgia, 5100
        • Novartis Investigative Site
      • Jette, Belgia, 1090
        • Novartis Investigative Site
      • Kortrijk, Belgia, 8500
        • Novartis Investigative Site
      • Leuven, Belgia, 3000
        • Novartis Investigative Site
      • Liege, Belgia, 4000
        • Novartis Investigative Site
      • Liège, Belgia, 4000
        • Novartis Investigative Site
      • Malmedy, Belgia, 4960
        • Novartis Investigative Site
      • Menen, Belgia, 8930
        • Novartis Investigative Site
      • Montigny-le-tilleul, Belgia, 6110
        • Novartis Investigative Site
      • Namur, Belgia, 5000
        • Novartis Investigative Site
      • Oostende, Belgia, 8400
        • Novartis Investigative Site
      • Turnhout, Belgia, 2300
        • Novartis Investigative Site
  • Brasil
    • GO
      • Goiania, GO, Brasil, 74605-050
        • Novartis Investigative Site
    • MG
      • Juiz de Fora, MG, Brasil, 36036-110
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brasil, 22271-110
        • Novartis Investigative Site
    • RS
      • Caxias do Sul, RS, Brasil, 95070-560
        • Novartis Investigative Site
      • Porto Alegre, RS, Brasil, 90020-090
        • Novartis Investigative Site
      • Porto Alegre, RS, Brasil, 90610-000
        • Novartis Investigative Site
      • Porto Alegre, RS, Brasil, 90880-480
        • Novartis Investigative Site
    • SP
      • São Paulo, SP, Brasil, 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 føderasjonen
      • Chelyabinsk, Den russiske føderasjonen, 454021
        • Novartis Investigative Site
      • Chelyabinsk, Den russiske føderasjonen, 454047
        • Novartis Investigative Site
      • Ekaterinburg, Den russiske føderasjonen, 620109
        • Novartis Investigative Site
      • Ekaterinburg, Den russiske føderasjonen, 620219
        • Novartis Investigative Site
      • Kazan, Den russiske føderasjonen, 420015
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 121359
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 105229
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 119992
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 115280
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 105077
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 115446
        • Novartis Investigative Site
      • Moscow, Den russiske føderasjonen, 121609
        • Novartis Investigative Site
      • Samara, Den russiske føderasjonen, 443079
        • Novartis Investigative Site
      • Sankt-Peterburg, Den russiske føderasjonen, 197022
        • Novartis Investigative Site
      • St. Petersburg, Den russiske føderasjonen, 194354
        • Novartis Investigative Site
      • St.-Petersburg, Den russiske føderasjonen, 193231
        • Novartis Investigative Site
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Den russiske føderasjonen, 420015
        • Novartis Investigative Site
  • Estland
      • Rakvere, Estland, 44310
        • Novartis Investigative Site
      • Tallinn, Estland, 13619
        • Novartis Investigative Site
      • Tartu, Estland, 51014
        • Novartis Investigative Site
  • Filippinene
      • Quezon City, Filippinene, 1100
        • Novartis Investigative Site
      • Quezon City, Filippinene, 1101
        • Novartis Investigative Site
    • Metro Manila
      • Quezon City, Metro Manila, Filippinene, 1109
        • Novartis Investigative Site
      • Quezon City, Metro Manila, Filippinene, 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
  • Frankrike
      • Beuvry, Frankrike, 62660
        • Novartis Investigative Site
      • Bourges, Frankrike, 18000
        • Novartis Investigative Site
      • Ferolles-Attily, Frankrike, 77150
        • Novartis Investigative Site
      • Lyon cedex 04, Frankrike, 69317
        • Novartis Investigative Site
      • Montpellier, Frankrike, 34059
        • Novartis Investigative Site
      • Nantes, Frankrike, 44000
        • Novartis Investigative Site
      • Nice Cedex 1, Frankrike, 06602
        • Novartis Investigative Site
      • Ollioules Cedex, Frankrike, 83192
        • Novartis Investigative Site
      • Paris, Frankrike, 75006
        • Novartis Investigative Site
      • Perpignan Cedex, Frankrike, 66025
        • Novartis Investigative Site
      • Pessac, Frankrike, 33604
        • Novartis Investigative Site
      • Reims, Frankrike, 51092
        • Novartis Investigative Site
      • St Michel, Frankrike, 16470
        • Novartis Investigative Site
      • Vandoeuvre les Nancy, Frankrike, 54511
        • 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
  • 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
  • Italia
      • Napoli, Italia, 80131
        • Novartis Investigative Site
      • Pisa, Italia, 56124
        • Novartis Investigative Site
    • BA
      • Acquaviva delle Fonti, BA, Italia, 70021
        • Novartis Investigative Site
      • Bari, BA, Italia, 70124
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italia, 24128
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italia, 25127
        • Novartis Investigative Site
    • CZ
      • Catanzaro, CZ, Italia, 88100
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italia, 44100
        • Novartis Investigative Site
    • FR
      • Cassino, FR, Italia, 03043
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italia, 16132
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italia, 20142
        • Novartis Investigative Site
      • Milano, MI, Italia, 20126
        • Novartis Investigative Site
      • Milano, MI, Italia, 20157
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italia, 41100
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italia, 90146
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italia, 33170
        • Novartis Investigative Site
    • PO
      • Prato, PO, Italia, 59100
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italia, 43100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italia, 00168
        • Novartis Investigative Site
      • Roma, RM, Italia, 00161
        • Novartis Investigative Site
      • Roma, RM, Italia, 00133
        • Novartis Investigative Site
      • Roma, RM, Italia, 00163
        • Novartis Investigative Site
    • SA
      • Cava Dei Tirreni, SA, Italia, 84013
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italia, 53100
        • Novartis Investigative Site
    • TE
      • Teramo, TE, Italia, 64100
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italia, 10043
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italia, 34149
        • Novartis Investigative Site
    • VA
      • Cuasso al Monte, VA, Italia, 21050
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italia, 37126
        • 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
  • Latvia
      • Riga, Latvia, 1002
        • Novartis Investigative Site
    • LV
      • Riga, LV, Latvia, 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
  • Nederland
      • Almelo, Nederland, 7609 PP
        • Novartis Investigative Site
      • Breda, Nederland, 4819 EV
        • Novartis Investigative Site
      • Eindhoven, Nederland, 5623 EJ
        • Novartis Investigative Site
      • Enschede, Nederland, 7513 ER
        • Novartis Investigative Site
      • Rotterdam, Nederland, 3045 PM
        • Novartis Investigative Site
      • Sneek, Nederland, 8601 ZK
        • Novartis Investigative Site
      • Zwolle, Nederland, 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
  • 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
  • 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
  • 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
  • Spania
      • Madrid, Spania, 28007
        • Novartis Investigative Site
      • Madrid, Spania, 28040
        • Novartis Investigative Site
    • Andalucia
      • Jerez de La Frontera, Andalucia, Spania, 11407
        • Novartis Investigative Site
      • Malaga, Andalucia, Spania, 29010
        • Novartis Investigative Site
      • Sanlúcar de Barrameda, Andalucia, Spania, 11540
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spania, 41009
        • Novartis Investigative Site
    • Asturias
      • Gijon, Asturias, Spania, 33290
        • Novartis Investigative Site
    • Castilla la Mancha
      • Illescas, Castilla la Mancha, Spania, 45200
        • Novartis Investigative Site
    • Castilla y Leon
      • Valladolid, Castilla y Leon, Spania, 47011
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spania, 08003
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spania, 08041
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spania, 08036
        • Novartis Investigative Site
      • Salt, Cataluña, Spania, 17190
        • Novartis Investigative Site
      • Sant Boi de Llobregat, Cataluña, Spania, 08830
        • Novartis Investigative Site
      • Terrassa, Cataluña, Spania, 08221
        • Novartis Investigative Site
      • Vic, Cataluña, Spania, 08500
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spania, 03114
        • Novartis Investigative Site
      • Alzira, Comunidad Valenciana, Spania, 46600
        • Novartis Investigative Site
      • Requena, Comunidad Valenciana, Spania, 46340
        • Novartis Investigative Site
    • Extremadura
      • Caceres, Extremadura, Spania, 10003
        • Novartis Investigative Site
      • Mérida, Extremadura, Spania, 06800
        • Novartis Investigative Site
      • Plasencia, Extremadura, Spania, 10600
        • Novartis Investigative Site
    • Galicia
      • La Coruna, Galicia, Spania, 15006
        • Novartis Investigative Site
      • Lugo, Galicia, Spania, 27003
        • Novartis Investigative Site
      • Santiago de Compostela, Galicia, Spania, 15706
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spania, 28223
        • Novartis Investigative Site
  • Storbritannia
      • Belfast, Storbritannia, BT7 2BE
        • Novartis Investigative Site
      • Bexhill-on-Sea, Storbritannia, TN40 1JJ
        • Novartis Investigative Site
      • Bradford, Storbritannia, BD9 6RJ
        • Novartis Investigative Site
      • Bristol, Storbritannia, BS10 5NB
        • Novartis Investigative Site
      • Cambridge, Storbritannia, CB7 5JD
        • Novartis Investigative Site
      • Lancashire, Storbritannia, FY3 7EN
        • Novartis Investigative Site
      • Lancashire, Storbritannia, B13 6TL
        • Novartis Investigative Site
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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Indacaterol
Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Legemiddel: Indacaterol 150 µg
Indacaterol 150 µg o.d. delivered via SDDPI
Aktiv komparator: Tiotropium
Tiotropium 18 µg o.d. delivered via the handihaler®
Legemiddel: Tiotropium
Tiotropium 18 µg o.d. delivered via handihaler®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2009

Primær fullføring (Faktiske)

1. juli 2012

Studiet fullført (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først innsendt

15. februar 2009

Først innsendt som oppfylte QC-kriteriene

17. februar 2009

Først lagt ut (Anslag)

18. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. november 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2013

Sist bekreftet

1. september 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CQAB149B2348
  • 2008-007944-33

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Indacaterol 150 µg

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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