AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3INVIGORATENCT00845728

Exacerbation Study

A Phase 3 study testing Indacaterol 150 µg and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 423 sites in 40 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Indacaterol 150 µg and Tiotropium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,439 participants
Where
423 sitesin 40 countries
Study dates
Mar 2009to Jul 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Smoking history of at least 10 pack years, both current and ex-smokers are eligible
  • A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Who cannot join

  • 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

Trial locations and contacts

423 sites in 40 countries.

423 sites in 40 countries

Germany43 sites

  • Novartis Investigative Site

    Bad Wörishofen, 86825

  • Novartis Investigative Site

    Berlin, Germany, 10969

  • Novartis Investigative Site

    Berlin, Germany, 14050

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 12043

  • Novartis Investigative Site

    Berlin, 12687

  • Novartis Investigative Site

    Berlin, 13057

  • Novartis Investigative Site

    Berlin, 13086

  • Novartis Investigative Site

    Berlin, 13507

  • Novartis Investigative Site

    Berlin, 13581

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Bonn, 53123

  • Novartis Investigative Site

    Borstel, 23845

  • Novartis Investigative Site

    Dachau, 85221

  • Novartis Investigative Site

    Euskirchen, 53879

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Fürstenwalde, 15517

  • Novartis Investigative Site

    Güstrow, 18273

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 20357

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hamburg, 22305

  • Novartis Investigative Site

    Hoyerswerda, 02977

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, Germany, 04207

  • Novartis Investigative Site

    Mainz, Germany, D-55101

  • Novartis Investigative Site

    Marburg, Germany, 35037

  • Novartis Investigative Site

    München, Germany, 80331

  • Novartis Investigative Site

    München, 80335

  • Novartis Investigative Site

    München, 80539

  • Novartis Investigative Site

    München, 81243

  • Novartis Investigative Site

    München, 81677

  • Novartis Investigative Site

    Neu-Ulm, 89231

  • Novartis Investigative Site

    Neumünster, 24534

  • Novartis Investigative Site

    Neuss, 41462

  • Novartis Investigative Site

    Oranienburg, 16515

  • Novartis Investigative Site

    Radebeul, 01445

  • Novartis Investigative Site

    Ratingen, 40878

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Teterow, Germany, 17166

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Wedel, 22880

  • Novartis Investigative Site

    Witten, 58452

Other trials in Germany

Italy29 sites

  • Novartis Investigative Site

    Acquaviva delle Fonti, BA, 70021

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Bergamo, BG, 24128

  • Novartis Investigative Site

    Brescia, BS, 25127

  • Novartis Investigative Site

    Cassino, FR, 03043

  • Novartis Investigative Site

    Catanzaro, CZ, 88100

  • Novartis Investigative Site

    Cava de' Tirreni, SA, 84013

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Cuasso al Monte, VA, 21050

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20126

  • Novartis Investigative Site

    Milan, MI, 20142

  • Novartis Investigative Site

    Milan, MI, 20157

  • Novartis Investigative Site

    Modena, MO, 41100

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Pisa, Italy, 56124

  • Novartis Investigative Site

    Pordenone, PN, 33170

  • Novartis Investigative Site

    Prato, PO, 59100

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00163

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Teramo, TE, 64100

  • Novartis Investigative Site

    Trieste, TS, 34149

  • Novartis Investigative Site

    Verona, VR, 37126

Other trials in Italy

Spain26 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Alicante, Valencia, 03114

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, Catalonia, 08041

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

  • Novartis Investigative Site

    Gijón, Principality of Asturias, 33290

  • Novartis Investigative Site

    Illescas, Castille-La Mancha, 45200

  • Novartis Investigative Site

    Jerez de la Frontera, Andalusia, 11407

  • Novartis Investigative Site

    Lugo, Galicia, 27003

  • Novartis Investigative Site

    Madrid, Madrid, 28007

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Mérida, Extremadura, 06800

  • Novartis Investigative Site

    Plasencia, Extremadura, 10600

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Requena, Valencia, 46340

  • Novartis Investigative Site

    Salt, Catalonia, 17190

  • Novartis Investigative Site

    Sanlúcar de Barrameda, Andalusia, 11540

  • Novartis Investigative Site

    Sant Boi de Llobregat, Catalonia, 08830

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Terrassa, Catalonia, 08221

  • Novartis Investigative Site

    Valladolid, Castille and León, 47011

  • Novartis Investigative Site

    Vic, Catalonia, 08500

Other trials in Spain

Belgium23 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Duffel, 2570

  • Novartis Investigative Site

    Eupen, 4700

  • Novartis Investigative Site

    Framerie, Belgium, 7080

  • Novartis Investigative Site

    Geraardsbergen, Belgium, 9500

  • Novartis Investigative Site

    Gilly, Belgium, 6060

  • Novartis Investigative Site

    Godinne, 5530

  • Novartis Investigative Site

    Gozée, 6534

  • Novartis Investigative Site

    Herentals, 2200

  • Novartis Investigative Site

    Jambes, 5100

  • Novartis Investigative Site

    Jette, 1090

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Malmedy, Belgium, 4960

  • Novartis Investigative Site

    Menen, Belgium, 8930

  • Novartis Investigative Site

    Montigny-le-Tilleul, 6110

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Ostend, 8400

  • Novartis Investigative Site

    Turnhout, 2300

Other trials in Belgium

United Kingdom22 sites

  • Novartis Investigative Site

    Ash Vale, Surrey, GU12 5BA

  • Novartis Investigative Site

    Belfast, BT7 2BE

  • Novartis Investigative Site

    Bexhill-on-Sea, TN40 1JJ

  • Novartis Investigative Site

    Bradford, BD9 6RJ

  • Novartis Investigative Site

    Bristol, BS10 5NB

  • Novartis Investigative Site

    Cambridge, United KIngdom, CB7 5JD

  • Novartis Investigative Site

    Crawley, West Sussex, RH10 7DX

  • Novartis Investigative Site

    Lancashire, B13 6TL

  • Novartis Investigative Site

    Lancashire, FY3 7EN

  • Novartis Investigative Site

    Liverpool, L9 7AL

  • Novartis Investigative Site

    London, E2 9JX

  • Novartis Investigative Site

    London, SW3 6PH

  • Novartis Investigative Site

    London, W1G 8HU

  • Novartis Investigative Site

    Newcastle upon Tyne, Newcastle, NE7 7DN

  • Novartis Investigative Site

    Newport, P030 5TG

  • Novartis Investigative Site

    Stockport, SK4 4NX

  • Novartis Investigative Site

    Stockport, SK8 6LU

  • Novartis Investigative Site

    Surrey, KT16 0PZ

  • Novartis Investigative Site

    Swansea, England, SA6 6NL

  • Novartis Investigative Site

    Warminster, BA12 9AA

  • Novartis Investigative Site

    Watford, United Kingdom, WD25 0EA

  • Novartis Investigative Site

    Windsor, SL4 3DP

Other trials in United Kingdom

Canada20 sites

  • Novartis Investigative Site

    Burlington, Ontario, L7N 3V2

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N1

  • Novartis Investigative Site

    Calgary, Alberta, T2V 1P9

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2B7

  • Novartis Investigative Site

    Kelowna, British Columbia, V1Y 1E4

  • Novartis Investigative Site

    Mississauga, Ontario, L5B 4A9

  • Novartis Investigative Site

    Moncton, New Brunswick, E1G 1A7

  • Novartis Investigative Site

    Montreal, Quebec, H2L 2W5

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Montreal, Quebec, H2X 2P4

  • Novartis Investigative Site

    Montreal, Quebec, H4J 1C5

  • Novartis Investigative Site

    Newmarket, Ontario, L3Y 5G8

  • Novartis Investigative Site

    Ottawa, Ontario, K1Y 4G2

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 4G5

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 4J6

  • Novartis Investigative Site

    Toronto, Ontario, M5G1N8

  • Novartis Investigative Site

    Toronto, Ontario, M5T 3A9

  • Novartis Investigative Site

    Toronto, Ontario, M6H 3M2

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 3J5

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

Czechia18 sites

  • Novartis Investigative Site

    Beroun, Czech Republic

  • Novartis Investigative Site

    České Budějovice, Czech Republic, 370 87

  • Novartis Investigative Site

    Český Krumlov, Czech Republic, 381 01

  • Novartis Investigative Site

    Cvikov, Czech Republic, 471 54

  • Novartis Investigative Site

    Karlovy Vary, Czech Republic, 360 06

  • Novartis Investigative Site

    Karlovy Vary, Czech Republic, 360 66

  • Novartis Investigative Site

    Kuřim, Czech Republic, 66434

  • Novartis Investigative Site

    Kyjov, CZE, 697 70

  • Novartis Investigative Site

    Nový Jičín, 741 01

  • Novartis Investigative Site

    Ostrava, Czech Republic, 70030

  • Novartis Investigative Site

    Ostrava - Hrabuvka, Czech Republic, 70030

  • Novartis Investigative Site

    Prague, Czech Republic, 169 00

  • Novartis Investigative Site

    Přerov, Czech Republic, 75000

  • Novartis Investigative Site

    Rokycany, Czech Republic, 337 22

  • Novartis Investigative Site

    Rudná, Czech Republic, 25219

  • Novartis Investigative Site

    Strakonice, Czech Republic, 38601

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Žatec, Czech Republic, 438 01

Other trials in Czechia

India18 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380009

  • Novartis Investigative Site

    Ahmedabad, Gujrat-India, 380054

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 002

  • Novartis Investigative Site

    Bangalore, Karnataka, 560002

  • Novartis Investigative Site

    Calicut, Kerala, 673008

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 002

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500004

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500012

  • Novartis Investigative Site

    Indore, Madhya Pradesh, 452001

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302023

  • Novartis Investigative Site

    Mangalore, Karnataka, 575001

  • Novartis Investigative Site

    Nagpur - Maharashtra, India, 440012

  • Novartis Investigative Site

    Nagpur - Maharastra, India, 400 012

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029

  • Novartis Investigative Site

    Noida, New Delhi, 201301

  • Novartis Investigative Site

    Panjim, 403002

  • Novartis Investigative Site

    Trivandrum, Kerala, 695011

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632004

Other trials in India

Russia17 sites

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Chelyabinsk, 454047

  • Novartis Investigative Site

    Kazan', Tatarstan Republic, 420015

  • Novartis Investigative Site

    Kazan', 420015

  • Novartis Investigative Site

    Moscow, 105077

  • Novartis Investigative Site

    Moscow, 105229

  • Novartis Investigative Site

    Moscow, 115280

  • Novartis Investigative Site

    Moscow, 115446

  • Novartis Investigative Site

    Moscow, 119992

  • Novartis Investigative Site

    Moscow, 121359

  • Novartis Investigative Site

    Moscow, 121609

  • Novartis Investigative Site

    Saint Petersburg, 193231

  • Novartis Investigative Site

    Saint Petersburg, 194354

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Samara, 443079

  • Novartis Investigative Site

    Yekaterinburg, 620109

  • Novartis Investigative Site

    Yekaterinburg, 620219

Other trials in Russia

Argentina14 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, 5000

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, B1842DID

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1122AAK

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1125ABE

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1221ADC

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1426ABP

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, C1424BSF

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Mendoza, Mendoza Province, M5500CCG

  • Novartis Investigative Site

    Pilar, Buenos Aires, B1629AHJ

  • Novartis Investigative Site

    Rosario, Santa Fe Province, C2000DSR

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AYW

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

France14 sites

  • Novartis Investigative Site

    Beuvry, France, 62660

  • Novartis Investigative Site

    Bourges, France, 18000

  • Novartis Investigative Site

    Ferolles-Attily, France, 77150

  • Novartis Investigative Site

    Lyon, 69317

  • Novartis Investigative Site

    Montpellier, 34059

  • Novartis Investigative Site

    Nantes, 44000

  • Novartis Investigative Site

    Nice, 06602

  • Novartis Investigative Site

    Ollioules, 83192

  • Novartis Investigative Site

    Paris, 75006

  • Novartis Investigative Site

    Perpignan, 66025

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Reims, 51092

  • Novartis Investigative Site

    Saint-Michel-sur-Orge, 16470

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Turkey (Türkiye)14 sites

  • Novartis Investigative Site

    Ankara, Turkey, 06100

  • Novartis Investigative Site

    Çanakkale, 17100

  • Novartis Investigative Site

    Diskapi / Ankara, 06110

  • Novartis Investigative Site

    Emek / Ankara, 06510

  • Novartis Investigative Site

    Gaziantep, 27070

  • Novartis Investigative Site

    Isparta, Turkey, 32100

  • Novartis Investigative Site

    Istanbul

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kahramanmaraş, Turkey, 46100

  • Novartis Investigative Site

    Kecioren / Ankara, 06280

  • Novartis Investigative Site

    Kozlu / Zonguldak, 67600

  • Novartis Investigative Site

    Malatya, 44280

  • Novartis Investigative Site

    Mersin, 33079

  • Novartis Investigative Site

    Yenisehir/Izmir, 35110

Other trials in Turkey (Türkiye)

China11 sites

  • Novartis Investigative Site

    Beijing, 100020

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Changsha, Hunan, 410003

  • Novartis Investigative Site

    Changsha, Hunan, 410011

  • Novartis Investigative Site

    Chongqing, 400037

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shengyang, Liaoning, 110016

  • Novartis Investigative Site

    Shenyang, 110001

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000

  • Novartis Investigative Site

    Xi’an, Shanxi, 710032

  • Novartis Investigative Site

    Xi’an, Shanxi, 710061

Other trials in China

Hungary10 sites

  • Novartis Investigative Site

    Budapest, 1125

  • Novartis Investigative Site

    Cegléd, Hungary, 2700

  • Novartis Investigative Site

    Debrecen, Hungary, 4032

  • Novartis Investigative Site

    Deszk, 6772

  • Novartis Investigative Site

    Mosonmagyaróvár, 9200

  • Novartis Investigative Site

    Nyíregyháza, 4400

  • Novartis Investigative Site

    Sopron, 9400

  • Novartis Investigative Site

    Szarvas, Hungary, 5540

  • Novartis Investigative Site

    Tatabánya, Hungary, 2800

  • Novartis Investigative Site

    Törökbálint, 2045

Other trials in Hungary

Peru9 sites

  • Novartis Investigative Site

    Jesus Maria, Lima region, 11

  • Novartis Investigative Site

    La Victoria, Lima region, 13

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

  • Novartis Investigative Site

    Miraflores, Lima region, 18

  • Novartis Investigative Site

    San Borja, Lima region, 41

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    San Martín de Porres, Lima region, 31

  • Novartis Investigative Site

    San Miguel, Lima region, 32

  • Novartis Investigative Site

    Santiago de Surco, Lima region, 33

Other trials in Peru

Poland9 sites

  • Novartis Investigative Site

    Gdansk, 80-169

  • Novartis Investigative Site

    Gdansk, 80-847

  • Novartis Investigative Site

    Katowice, 40-752

  • Novartis Investigative Site

    Krakow, 31-159

  • Novartis Investigative Site

    Krakow, 31-202

  • Novartis Investigative Site

    Krakow, 31-455

  • Novartis Investigative Site

    Warsaw, 01-138

  • Novartis Investigative Site

    Warsaw, 02-341

  • Novartis Investigative Site

    Wroclaw, 50-044

Other trials in Poland

Brazil8 sites

  • Novartis Investigative Site

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Novartis Investigative Site

    Goiânia, Goiás, 74605-050

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais, 36036-110

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22271-110

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-062

Other trials in Brazil

Slovakia8 sites

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 821 06

  • Novartis Investigative Site

    Bratislava, 826 06

  • Novartis Investigative Site

    Košice, Slovak Republic, 041 90

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Lučenec, 984 39

  • Novartis Investigative Site

    Nové Zámky, 940 01

  • Novartis Investigative Site

    Poprad, 058 01

  • Novartis Investigative Site

    Spišská Nová Ves, Slovak Republic, 052 01

Other trials in Slovakia

Sweden8 sites

  • Novartis Investigative Site

    Gothenburg, 412 63

  • Novartis Investigative Site

    Gothenburg, 413 45

  • Novartis Investigative Site

    Luleå, SE-971 80

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Malmö, 205 02

  • Novartis Investigative Site

    Skellefteå, Sweden, SE 931 32

  • Novartis Investigative Site

    Stockholm, S-171 76

  • Novartis Investigative Site

    Sundsvall, 851 86

Other trials in Sweden

Switzerland8 sites

  • Novartis Investigative Site

    Bern, 3013

  • Novartis Investigative Site

    Crans-Montana, 3963

  • Novartis Investigative Site

    Faltigberg-Wald, Canton of Zurich, 8639

  • Novartis Investigative Site

    Lausanne, 1011

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Thun, 3600

  • Novartis Investigative Site

    Winterthur, 8401

  • Novartis Investigative Site

    Zurich, 8032

Other trials in Switzerland

Australia7 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Bankstown, New South Wales, 2200

  • Novartis Investigative Site

    Daw Park, South Australia, 5041

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    Parkville, Victoria, 3050

  • Novartis Investigative Site

    Tauranga, New Zealand, 3001

Other trials in Australia

Austria7 sites

  • Novartis Investigative Site

    Feldbach, Austria, 8330

  • Novartis Investigative Site

    Gänserndorf, Austria, 2230

  • Novartis Investigative Site

    Grieskirchen, Austria, 4710

  • Novartis Investigative Site

    Hallein, Austria, 5400

  • Novartis Investigative Site

    Linz, Austria, 4020

  • Novartis Investigative Site

    Perg, Austria, 4320

  • Novartis Investigative Site

    Zwettl Stadt, Austria, 3910

Other trials in Austria

Denmark7 sites

  • Novartis Investigative Site

    Aalborg, Denmark, DK-9100

  • Novartis Investigative Site

    Aarhus, DK-8000

  • Novartis Investigative Site

    Copenhagen NV, DK-2400

  • Novartis Investigative Site

    Elsinore, Denmark, DK-3000

  • Novartis Investigative Site

    Hellerup, Denmark, DK-2900

  • Novartis Investigative Site

    Hvidovre, Denmark, DK-2650

  • Novartis Investigative Site

    Odense C, DK-5000

Other trials in Denmark

Finland7 sites

  • Novartis Investigative Site

    Helsinki, Finland, 00029

  • Novartis Investigative Site

    HUS, 00029

  • Novartis Investigative Site

    Jyväskylä, Finland, 40100

  • Novartis Investigative Site

    Pori, FIN-28500

  • Novartis Investigative Site

    Porvoo, FIN-06200

  • Novartis Investigative Site

    Tampere, FIN-33521

  • Novartis Investigative Site

    Turku, Finland, FIN-20100

Other trials in Finland

Netherlands7 sites

  • Novartis Investigative Site

    Almelo, Netherlands, 7609 PP

  • Novartis Investigative Site

    Breda, Netherlands, 4819 EV

  • Novartis Investigative Site

    Eindhoven, 5623 EJ

  • Novartis Investigative Site

    Enschede, Netherlands, 7513 ER

  • Novartis Investigative Site

    Rotterdam, 3045 PM

  • Novartis Investigative Site

    Sneek, 8601 ZK

  • Novartis Investigative Site

    Zwolle, 8011 JW

Other trials in Netherlands

Portugal7 sites

  • Novartis Investigative Site

    Amadora, 2720-276

  • Novartis Investigative Site

    Coimbra, 3000-075

  • Novartis Investigative Site

    Coimbra, 3041-853

  • Novartis Investigative Site

    Lisbon, 1169-024

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Lisbon, 1769-001

  • Novartis Investigative Site

    Porto, 4200-319

Other trials in Portugal

Romania6 sites

  • Novartis Investigative Site

    Brasov, Jud. Brasov, 500118

  • Novartis Investigative Site

    Bucharest, District 3, 030303

  • Novartis Investigative Site

    Bucharest, 060011

  • Novartis Investigative Site

    Cluj-Napoca, 400371

  • Novartis Investigative Site

    Constanța, Jud. Constanta, 900002

  • Novartis Investigative Site

    Iași, Jud. Iasi, 700115

Other trials in Romania

Israel5 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Rehovot, 76100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Lithuania5 sites

  • Novartis Investigative Site

    Kaunas, 44320

  • Novartis Investigative Site

    Klaipėda, LT-92231

  • Novartis Investigative Site

    Šiauliai, LT-76231

  • Novartis Investigative Site

    Utena, LT-28151

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Mexico5 sites

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44100

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44280

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64450

  • Novartis Investigative Site

    Pachuca, Hidalgo, 42090

  • Novartis Investigative Site

    San Luis Potosí City, San Luis Potosí, 78218

Other trials in Mexico

Taiwan5 sites

  • Novartis Investigative Site

    Taichung, Taiwan, 40447

  • Novartis Investigative Site

    Taichung, Taiwan, 40705

  • Novartis Investigative Site

    Taipei, Taiwan, 10002

  • Novartis Investigative Site

    Taipei, 110

  • Novartis Investigative Site

    Taipei County, Taiwan

Other trials in Taiwan

Philippines4 sites

  • Novartis Investigative Site

    Quezon City, National Capital Region, 1104

  • Novartis Investigative Site

    Quezon City, National Capital Region, 1109

  • Novartis Investigative Site

    Quezon City, Philippines, 1101

  • Novartis Investigative Site

    Quezon City, 1100

Other trials in Philippines

South Africa4 sites

  • Novartis Investigative Site

    Bloemfontein, 9301

  • Novartis Investigative Site

    Bloemfontein, 9317

  • Novartis Investigative Site

    Cape Town, 8001

  • Novartis Investigative Site

    Durban, South Africa, 4001

Other trials in South Africa

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, 40002

  • Novartis Investigative Site

    Songkhla, 90110

Other trials in Thailand

Colombia3 sites

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Medellín

Other trials in Colombia

Estonia3 sites

  • Novartis Investigative Site

    Rakvere, 44310

  • Novartis Investigative Site

    Tallinn, 13619

  • Novartis Investigative Site

    Tartu, Estonia, 51014

Other trials in Estonia

Venezuela3 sites

  • Novartis Investigative Site

    Barquisimeto, Lara, 3002

  • Novartis Investigative Site

    Maracaibo, Zulia, 4002

  • Novartis Investigative Site

    Valencia, Carabobo, 2005

Other trials in Venezuela

Costa Rica2 sites

  • Novartis Investigative Site

    San Francisco de Asís, Costa Rica

  • Novartis Investigative Site

    San José, Costa Rica

Other trials in Costa Rica

Latvia2 sites

  • Novartis Investigative Site

    Riga, LV, LV-1038

  • Novartis Investigative Site

    Riga, 1002

Other trials in Latvia

Iceland1 site

  • Novartis Investigative Site

    Reykjavik, IS-109

Other trials in Iceland

About this study

Official title: 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

Being tested
Indacaterol 150 µg, Tiotropium
Keywords
Indacaterol, Tiotropium, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indacaterol 150 µgDrug

    Indacaterol 150 µg o.d. delivered via SDDPI

  • TiotropiumDrug

    Tiotropium 18 µg o.d. delivered via handihaler®

Study groups in NCT00845728
Study groupRoleWhat they receive
IndacaterolExperimentalIndacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Receives: Drug: Indacaterol 150 µg
TiotropiumActive comparatorTiotropium 18 µg o.d. delivered via the handihaler®
Receives: Drug: Tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trough Forced Expiratory Volume in 1 Second (FEV1).

    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.

    Measured: 12 weeks

Secondary outcomes (1)

  1. Rate of COPD Exacerbations

    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.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00845728
Sponsor's protocol ID
CQAB149B2348
Other IDs
2008-007944-33, 2008
Acronym
INVIGORATE
Status last verified
Sep 2013
First submitted
15 Feb 2009
Last updated
19 Nov 2013
Data monitoring committee
Yes

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.

    PubMed 24461613

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 150 µg and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 423 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 423 sites in Germany, Italy, Spain, Belgium, United Kingdom and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough Forced Expiratory Volume in 1 Second (FEV1). (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00845728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in