Chronic Obstructive Pulmonary Disease Clinical Trial
— INVIGORATEOfficial 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
| Status | Completed |
| Enrollment | 3439 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novartis Investigative Site | Buenos Aires | |
| Argentina | Novartis Investigative Site | Buenos Aires | |
| Argentina | Novartis Investigative Site | Buenos Aires | |
| Argentina | Novartis Investigative Site | Buenos Aires | |
| Argentina | Novartis Investigative Site | Buenos aires | |
| Argentina | Novartis Investigative Site | Buenos Aires | |
| Argentina | Novartis Investigative Site | Buenos Aires | |
| Argentina | Novartis Investigative Site | Capital Federal | Buenos Aires |
| Argentina | Novartis Investigative Site | Mar del Plata | Buenos Aires |
| Argentina | Novartis Investigative Site | Mendoza | |
| Argentina | Novartis Investigative Site | Pilar | Buenos Aires |
| Argentina | Novartis Investigative Site | Rosario | Santa Fe |
| Argentina | Novartis Investigative Site | Rosario | Santa Fe |
| Argentina | Novartis Investigative Site | San Miguel de Tucuman | Tucuman |
| Australia | Novartis Investigative Site | Adelaide | South Australia |
| Australia | Novartis Investigative Site | Bankstown | New South Wales |
| Australia | Novartis Investigative Site | Daw Park | South Australia |
| Australia | Novartis Investigative Site | Heidelberg | Victoria |
| Australia | Novartis Investigative Site | Nedlands | Western Australia |
| Australia | Novartis Investigative Site | Parkville | Victoria |
| Australia | Novartis Investigative Site | Tauranga, New Zealand | |
| Austria | Novartis Investigative Site | Feldbach | |
| Austria | Novartis Investigative Site | Gänserndorf | |
| Austria | Novartis Investigative Site | Grieskirchen | |
| Austria | Novartis Investigative Site | Hallein | |
| Austria | Novartis Investigative Site | Linz | |
| Austria | Novartis Investigative Site | Perg | |
| Austria | Novartis Investigative Site | Zwettl | |
| Belgium | Novartis Investigative Site | Aalst | |
| Belgium | Novartis Investigative Site | Antwerpen | |
| Belgium | Novartis Investigative Site | Bruxelles | |
| Belgium | Novartis Investigative Site | Bruxelles | |
| Belgium | Novartis Investigative Site | Duffel | |
| Belgium | Novartis Investigative Site | Eupen | |
| Belgium | Novartis Investigative Site | Framerie | |
| Belgium | Novartis Investigative Site | Geraardsbergen | |
| Belgium | Novartis Investigative Site | Gilly | |
| Belgium | Novartis Investigative Site | Godinne | |
| Belgium | Novartis Investigative Site | Gozée | |
| Belgium | Novartis Investigative Site | Herentals | |
| Belgium | Novartis Investigative Site | Jambes | |
| Belgium | Novartis Investigative Site | Jette | |
| Belgium | Novartis Investigative Site | Kortrijk | |
| Belgium | Novartis Investigative Site | Leuven | |
| Belgium | Novartis Investigative Site | Liege | |
| Belgium | Novartis Investigative Site | Liège | |
| Belgium | Novartis Investigative Site | Malmedy | |
| Belgium | Novartis Investigative Site | Menen | |
| Belgium | Novartis Investigative Site | Montigny-le-tilleul | |
| Belgium | Novartis Investigative Site | Namur | |
| Belgium | Novartis Investigative Site | Oostende | |
| Belgium | Novartis Investigative Site | Turnhout | |
| Brazil | Novartis Investigative Site | Caxias do Sul | RS |
| Brazil | Novartis Investigative Site | Goiania | GO |
| Brazil | Novartis Investigative Site | Juiz de Fora | MG |
| Brazil | Novartis Investigative Site | Porto Alegre | RS |
| Brazil | Novartis Investigative Site | Porto Alegre | RS |
| Brazil | Novartis Investigative Site | Porto Alegre | RS |
| Brazil | Novartis Investigative Site | Rio de Janeiro | RJ |
| Brazil | Novartis Investigative Site | São Paulo | SP |
| Canada | Novartis Investigative Site | Burlington | Ontario |
| Canada | Novartis Investigative Site | Calgary | Alberta |
| Canada | Novartis Investigative Site | Calgary | Alberta |
| Canada | Novartis Investigative Site | Edmonton | Alberta |
| Canada | Novartis Investigative Site | Kelowna | British Columbia |
| Canada | Novartis Investigative Site | Mississauga | Ontario |
| Canada | Novartis Investigative Site | Moncton | New Brunswick |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Canada | Novartis Investigative Site | Newmarket | Ontario |
| Canada | Novartis Investigative Site | Ottawa | Ontario |
| Canada | Novartis Investigative Site | Sainte-Foy | Quebec |
| Canada | Novartis Investigative Site | Sherbrooke | Quebec |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| Canada | Novartis Investigative Site | Vancouver | British Columbia |
| Canada | Novartis Investigative Site | Winnipeg | Manitoba |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Changsha | Hunan |
| China | Novartis Investigative Site | Changsha City | Hunan |
| China | Novartis Investigative Site | Chongqing | |
| China | Novartis Investigative Site | Shanghai | |
| China | Novartis Investigative Site | Shen Yang | |
| China | Novartis Investigative Site | Shengyang | Liaoning |
| China | Novartis Investigative Site | Shijiazhuang | Hebei |
| China | Novartis Investigative Site | Xi'an | Shanxi |
| China | Novartis Investigative Site | Xi'an | Shanxi |
| Colombia | Novartis Investigative Site | Barranquilla | |
| Colombia | Novartis Investigative Site | Bogotá | |
| Colombia | Novartis Investigative Site | Medellín | |
| Costa Rica | Novartis Investigative Site | San Francisco de Asís | |
| Costa Rica | Novartis Investigative Site | San Jose | |
| Czech Republic | Novartis Investigative Site | Beroun | |
| Czech Republic | Novartis Investigative Site | Ceske Budejovice | |
| Czech Republic | Novartis Investigative Site | Cesky Krumlov | |
| Czech Republic | Novartis Investigative Site | Cvikov | |
| Czech Republic | Novartis Investigative Site | Karlovy Vary | |
| Czech Republic | Novartis Investigative Site | Karlovy Vary | |
| Czech Republic | Novartis Investigative Site | Kurim | |
| Czech Republic | Novartis Investigative Site | Kyjov | CZE |
| Czech Republic | Novartis Investigative Site | Novy Jicin | |
| Czech Republic | Novartis Investigative Site | Ostrava | |
| Czech Republic | Novartis Investigative Site | Ostrava - Hrabuvka | |
| Czech Republic | Novartis Investigative Site | Praha 6 | |
| Czech Republic | Novartis Investigative Site | Prerov | |
| Czech Republic | Novartis Investigative Site | Rokycany | |
| Czech Republic | Novartis Investigative Site | Rudna | |
| Czech Republic | Novartis Investigative Site | Strakonice | |
| Czech Republic | Novartis Investigative Site | Teplice | |
| Czech Republic | Novartis Investigative Site | Zatec | |
| Denmark | Novartis Investigative Site | Aalborg | |
| Denmark | Novartis Investigative Site | Århus | |
| Denmark | Novartis Investigative Site | Copenhagen NV | |
| Denmark | Novartis Investigative Site | Hellerup | |
| Denmark | Novartis Investigative Site | Helsingor | |
| Denmark | Novartis Investigative Site | Hvidovre | |
| Denmark | Novartis Investigative Site | Odense C | |
| Estonia | Novartis Investigative Site | Rakvere | |
| Estonia | Novartis Investigative Site | Tallinn | |
| Estonia | Novartis Investigative Site | Tartu | |
| Finland | Novartis Investigative Site | Helsinki | |
| Finland | Novartis Investigative Site | HUS | |
| Finland | Novartis Investigative Site | Jyvaskyla | |
| Finland | Novartis Investigative Site | Pori | |
| Finland | Novartis Investigative Site | Porvoo | |
| Finland | Novartis Investigative Site | Tampere | |
| Finland | Novartis Investigative Site | Turku | |
| France | Novartis Investigative Site | Beuvry | |
| France | Novartis Investigative Site | Bourges | |
| France | Novartis Investigative Site | Ferolles-Attily | |
| France | Novartis Investigative Site | Lyon cedex 04 | |
| France | Novartis Investigative Site | Montpellier | |
| France | Novartis Investigative Site | Nantes | |
| France | Novartis Investigative Site | Nice Cedex 1 | |
| France | Novartis Investigative Site | Ollioules Cedex | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Perpignan Cedex | |
| France | Novartis Investigative Site | Pessac | |
| France | Novartis Investigative Site | Reims | |
| France | Novartis Investigative Site | St Michel | |
| France | Novartis Investigative Site | Vandoeuvre les Nancy | |
| Germany | Novartis Investigative Site | Bad Woerishofen | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Bonn | |
| Germany | Novartis Investigative Site | Bonn | |
| Germany | Novartis Investigative Site | Borstel | |
| Germany | Novartis Investigative Site | Dachau | |
| Germany | Novartis Investigative Site | Euskirchen | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Fürstenwalde/Spree | |
| Germany | Novartis Investigative Site | Güstrow | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Hoyerswerda | |
| Germany | Novartis Investigative Site | Landsberg | |
| Germany | Novartis Investigative Site | Leipzig | |
| Germany | Novartis Investigative Site | Mainz | |
| Germany | Novartis Investigative Site | Marburg | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | Muenchen | |
| Germany | Novartis Investigative Site | München | |
| Germany | Novartis Investigative Site | Neu-Ulm | |
| Germany | Novartis Investigative Site | Neumünster | |
| Germany | Novartis Investigative Site | Neuss | |
| Germany | Novartis Investigative Site | Oranienburg | |
| Germany | Novartis Investigative Site | Radebeul | |
| Germany | Novartis Investigative Site | Ratingen | |
| Germany | Novartis Investigative Site | Rüdersdorf | |
| Germany | Novartis Investigative Site | Teterow | |
| Germany | Novartis Investigative Site | Ulm | |
| Germany | Novartis Investigative Site | Wedel | |
| Germany | Novartis Investigative Site | Witten | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Cegled | |
| Hungary | Novartis Investigative Site | Debrecen | |
| Hungary | Novartis Investigative Site | Deszk | |
| Hungary | Novartis Investigative Site | Mosonmagyarovar | |
| Hungary | Novartis Investigative Site | Nyiregyhaza | |
| Hungary | Novartis Investigative Site | Sopron | |
| Hungary | Novartis Investigative Site | Szarvas | |
| Hungary | Novartis Investigative Site | Tatabanya | |
| Hungary | Novartis Investigative Site | Torokbalint | |
| Iceland | Novartis Investigative Site | Reykjavik | |
| India | Novartis Investigative Site | Ahmedabad | Gujrat-India |
| India | Novartis Investigative Site | Ahmedabad | Gujrat |
| India | Novartis Investigative Site | Bangalore | Karnataka |
| India | Novartis Investigative Site | Bangalore | Karnataka |
| India | Novartis Investigative Site | Calicut | Kerala |
| India | Novartis Investigative Site | Coimbatore | Tamil Nadu |
| India | Novartis Investigative Site | Hyderabad | Andhra Pradesh |
| India | Novartis Investigative Site | Hyderabad | Andhra Pradesh |
| India | Novartis Investigative Site | Indore | Madhya Pradesh |
| India | Novartis Investigative Site | Jaipur | Rajasthan |
| India | Novartis Investigative Site | Mangalore | Karnataka |
| India | Novartis Investigative Site | Nagpur - Maharashtra | |
| India | Novartis Investigative Site | Nagpur - Maharastra | |
| India | Novartis Investigative Site | New Delhi | Delhi |
| India | Novartis Investigative Site | Noida | New Delhi |
| India | Novartis Investigative Site | Panjim | |
| India | Novartis Investigative Site | Trivandrum | Kerala |
| India | Novartis Investigative Site | Vellore | Tamil Nadu |
| Israel | Novartis Investigative Site | Ashkelon | |
| Israel | Novartis Investigative Site | Jerusalem | |
| Israel | Novartis Investigative Site | Ramat Gan | |
| Israel | Novartis Investigative Site | Rehovot | |
| Israel | Novartis Investigative Site | Tel-Aviv | |
| Italy | Novartis Investigative Site | Acquaviva delle Fonti | BA |
| Italy | Novartis Investigative Site | Bari | BA |
| Italy | Novartis Investigative Site | Bergamo | BG |
| Italy | Novartis Investigative Site | Brescia | BS |
| Italy | Novartis Investigative Site | Cassino | FR |
| Italy | Novartis Investigative Site | Catanzaro | CZ |
| Italy | Novartis Investigative Site | Cava Dei Tirreni | SA |
| Italy | Novartis Investigative Site | Cona | FE |
| Italy | Novartis Investigative Site | Cuasso al Monte | VA |
| Italy | Novartis Investigative Site | Genova | GE |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Modena | MO |
| Italy | Novartis Investigative Site | Napoli | |
| Italy | Novartis Investigative Site | Orbassano | TO |
| Italy | Novartis Investigative Site | Palermo | PA |
| Italy | Novartis Investigative Site | Parma | PR |
| Italy | Novartis Investigative Site | Pisa | |
| Italy | Novartis Investigative Site | Pordenone | PN |
| Italy | Novartis Investigative Site | Prato | PO |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Siena | SI |
| Italy | Novartis Investigative Site | Teramo | TE |
| Italy | Novartis Investigative Site | Trieste | TS |
| Italy | Novartis Investigative Site | Verona | VR |
| Latvia | Novartis Investigative Site | Riga | LV |
| Latvia | Novartis Investigative Site | Riga | |
| Lithuania | Novartis Investigative Site | Kaunas | |
| Lithuania | Novartis Investigative Site | Klaipeda | |
| Lithuania | Novartis Investigative Site | Siauliai | |
| Lithuania | Novartis Investigative Site | Utena | |
| Lithuania | Novartis Investigative Site | Vilnius | |
| Mexico | Novartis Investigative Site | Guadalajara | Jalisco |
| Mexico | Novartis Investigative Site | Guadalajara | Jalisco |
| Mexico | Novartis Investigative Site | Monterrey | Nuevo León |
| Mexico | Novartis Investigative Site | Pachuca | Hidalgo |
| Mexico | Novartis Investigative Site | San Luis Potosí | |
| Netherlands | Novartis Investigative Site | Almelo | |
| Netherlands | Novartis Investigative Site | Breda | |
| Netherlands | Novartis Investigative Site | Eindhoven | |
| Netherlands | Novartis Investigative Site | Enschede | |
| Netherlands | Novartis Investigative Site | Rotterdam | |
| Netherlands | Novartis Investigative Site | Sneek | |
| Netherlands | Novartis Investigative Site | Zwolle | |
| Peru | Novartis Investigative Site | Cercado de Lima | Lima |
| Peru | Novartis Investigative Site | Jesus Maria | Lima |
| Peru | Novartis Investigative Site | La Victoria | Lima |
| Peru | Novartis Investigative Site | Miraflores | Lima |
| Peru | Novartis Investigative Site | San Borja | Lima |
| Peru | Novartis Investigative Site | San Isidro | Lima |
| Peru | Novartis Investigative Site | San Martin de Porres | Lima |
| Peru | Novartis Investigative Site | San Miguel | Lima |
| Peru | Novartis Investigative Site | Santiago de Surco | Lima |
| Philippines | Novartis Investigative Site | Quezon City | Metro Manila |
| Philippines | Novartis Investigative Site | Quezon City | Metro Manila |
| Philippines | Novartis Investigative Site | Quezon City | |
| Philippines | Novartis Investigative Site | Quezon City | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Katowice | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Warszawa | |
| Poland | Novartis Investigative Site | Warszawa | |
| Poland | Novartis Investigative Site | Wroclaw | |
| Portugal | Novartis Investigative Site | Amadora | |
| Portugal | Novartis Investigative Site | Coimbra | |
| Portugal | Novartis Investigative Site | Coimbra | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Porto | |
| Romania | Novartis Investigative Site | Brasov | Jud. Brasov |
| Romania | Novartis Investigative Site | Bucharest | District 3 |
| Romania | Novartis Investigative Site | Bucharest | |
| Romania | Novartis Investigative Site | Cluj-Napoca | |
| Romania | Novartis Investigative Site | Constanta | Jud. Constanta |
| Romania | Novartis Investigative Site | Iasi | Jud. Iasi |
| Russian Federation | Novartis Investigative Site | Chelyabinsk | |
| Russian Federation | Novartis Investigative Site | Chelyabinsk | |
| Russian Federation | Novartis Investigative Site | Ekaterinburg | |
| Russian Federation | Novartis Investigative Site | Ekaterinburg | |
| Russian Federation | Novartis Investigative Site | Kazan | |
| Russian Federation | Novartis Investigative Site | Kazan | Tatarstan Republic |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Samara | |
| Russian Federation | Novartis Investigative Site | Sankt-Peterburg | |
| Russian Federation | Novartis Investigative Site | St. Petersburg | |
| Russian Federation | Novartis Investigative Site | St.-Petersburg | |
| Slovakia | Novartis Investigative Site | Bratislava | Slovak Republic |
| Slovakia | Novartis Investigative Site | Bratislava | |
| Slovakia | Novartis Investigative Site | Kosice | |
| Slovakia | Novartis Investigative Site | Kosice | Slovak Republic |
| Slovakia | Novartis Investigative Site | Lucenec | |
| Slovakia | Novartis Investigative Site | Nove Zamky | |
| Slovakia | Novartis Investigative Site | Poprad | |
| Slovakia | Novartis Investigative Site | Spisska Nova Ves | Slovak Republic |
| South Africa | Novartis Investigative Site | Bloemfontein | |
| South Africa | Novartis Investigative Site | Bloemfontein | |
| South Africa | Novartis Investigative Site | Cape Town | |
| South Africa | Novartis Investigative Site | Durban | |
| Spain | Novartis Investigative Site | Alicante | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Alzira | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Barcelona | Cataluña |
| Spain | Novartis Investigative Site | Barcelona | Cataluña |
| Spain | Novartis Investigative Site | Barcelona | Cataluña |
| Spain | Novartis Investigative Site | Caceres | Extremadura |
| Spain | Novartis Investigative Site | Gijon | Asturias |
| Spain | Novartis Investigative Site | Illescas | Castilla la Mancha |
| Spain | Novartis Investigative Site | Jerez de La Frontera | Andalucia |
| Spain | Novartis Investigative Site | La Coruna | Galicia |
| Spain | Novartis Investigative Site | Lugo | Galicia |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Spain | Novartis Investigative Site | Mérida | Extremadura |
| Spain | Novartis Investigative Site | Plasencia | Extremadura |
| Spain | Novartis Investigative Site | Pozuelo de Alarcón | Madrid |
| Spain | Novartis Investigative Site | Requena | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Salt | Cataluña |
| Spain | Novartis Investigative Site | Sanlúcar de Barrameda | Andalucia |
| Spain | Novartis Investigative Site | Sant Boi de Llobregat | Cataluña |
| Spain | Novartis Investigative Site | Santiago de Compostela | Galicia |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Terrassa | Cataluña |
| Spain | Novartis Investigative Site | Valladolid | Castilla y Leon |
| Spain | Novartis Investigative Site | Vic | Cataluña |
| Sweden | Novartis Investigative Site | Göteborg | |
| Sweden | Novartis Investigative Site | Göteborg | |
| Sweden | Novartis Investigative Site | Luleå | |
| Sweden | Novartis Investigative Site | Lund | |
| Sweden | Novartis Investigative Site | Malmö | |
| Sweden | Novartis Investigative Site | Skellefteå | |
| Sweden | Novartis Investigative Site | Stockholm | |
| Sweden | Novartis Investigative Site | Sundsvall | |
| Switzerland | Novartis Investigative Site | Bern | |
| Switzerland | Novartis Investigative Site | Crans-Montana | |
| Switzerland | Novartis Investigative Site | Faltigberg-Wald | ZH |
| Switzerland | Novartis Investigative Site | Lausanne | |
| Switzerland | Novartis Investigative Site | St. Gallen | |
| Switzerland | Novartis Investigative Site | Thun | |
| Switzerland | Novartis Investigative Site | Winterthur | |
| Switzerland | Novartis Investigative Site | Zuerich | |
| Taiwan | Novartis Investigative Site | Taichung | |
| Taiwan | Novartis Investigative Site | Taichung | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taipei | |
| Taiwan | Novartis Investigative Site | Taipei County | |
| Thailand | Novartis Investigative Site | Bangkok | |
| Thailand | Novartis Investigative Site | Chiang Mai | |
| Thailand | Novartis Investigative Site | Khon Kaen | |
| Thailand | Novartis Investigative Site | Songkla | |
| Turkey | Novartis Investigative Site | Ankara | |
| Turkey | Novartis Investigative Site | Canakkale | |
| Turkey | Novartis Investigative Site | Diskapi / Ankara | |
| Turkey | Novartis Investigative Site | Emek / Ankara | |
| Turkey | Novartis Investigative Site | Gaziantep | |
| Turkey | Novartis Investigative Site | Isparta | |
| Turkey | Novartis Investigative Site | Istanbul | |
| Turkey | Novartis Investigative Site | Izmir | |
| Turkey | Novartis Investigative Site | Kahramanmaras | |
| Turkey | Novartis Investigative Site | Kecioren / Ankara | |
| Turkey | Novartis Investigative Site | Kozlu / Zonguldak | |
| Turkey | Novartis Investigative Site | Malatya | |
| Turkey | Novartis Investigative Site | Mersin | |
| Turkey | Novartis Investigative Site | Yenisehir/Izmir | |
| United Kingdom | Novartis Investigative Site | Ash Vale | Surrey |
| United Kingdom | Novartis Investigative Site | Belfast | |
| United Kingdom | Novartis Investigative Site | Bexhill-on-Sea | |
| United Kingdom | Novartis Investigative Site | Bradford | |
| United Kingdom | Novartis Investigative Site | Bristol | |
| United Kingdom | Novartis Investigative Site | Cambridge | |
| United Kingdom | Novartis Investigative Site | Crawley | West Sussex |
| United Kingdom | Novartis Investigative Site | Lancashire | |
| United Kingdom | Novartis Investigative Site | Lancashire | |
| United Kingdom | Novartis Investigative Site | Liverpool | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Newcastle Upon Tyne | Newcastle |
| United Kingdom | Novartis Investigative Site | Newport | |
| United Kingdom | Novartis Investigative Site | Stockport | |
| United Kingdom | Novartis Investigative Site | Stockport | |
| United Kingdom | Novartis Investigative Site | Surrey | |
| United Kingdom | Novartis Investigative Site | Swansea | England |
| United Kingdom | Novartis Investigative Site | Warminster | |
| United Kingdom | Novartis Investigative Site | Watford | |
| United Kingdom | Novartis Investigative Site | Windsor | |
| Venezuela | Novartis Investigative Site | Barquisimeto | Estado Lara |
| Venezuela | Novartis Investigative Site | Maracaibo | Estado Zulia |
| Venezuela | Novartis Investigative Site | Valencia | Estado Carabobo |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 12 weeks | No |
| Secondary | 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. | 52 weeks | No |
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