- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900731
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) (INTENSITY)
July 22, 2011 updated by: Novartis Pharmaceuticals
A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1598
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Feldbach, Austria
- Novartis Investigator Site
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Gänserndorf, Austria
- Novartis Investigator Site
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Hallein, Austria
- Novartis Investigator Site
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Bruxelles, Belgium
- Novartis Investigator Site
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Gilly, Belgium
- Novartis Investigator Site
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Jambes, Belgium
- Novartis Investigator Site
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Jette, Belgium
- Novartis Investigator Site
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Liège, Belgium
- Novartis Investigator Site
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Montigny-le-tilleul, Belgium
- Novartis Investigator Site
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Oostende, Belgium
- Novartis Investigator Site
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Saint Vith, Belgium
- Novartis Investigator Site
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Yvoir, Belgium
- Novartis Investigator Site
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Calgary, Canada
- Novartis Investigator Site
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Mississauga, Canada
- Novartis Investigative Site
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Moncton, Canada
- Novartis Investigative Site
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New Market, Canada
- Novartis Investigative Site
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Quebec, Canada
- Novartis Investigative Site
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St-Romuald, Canada
- Novartis Investigative Site
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Sudbury, Canada
- Novartis Investigative Site
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Barranquilla, Colombia
- Novartis Investigator Site
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Bogota, Colombia
- Novartis Investigator Site
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Medellin, Colombia
- Novartis Investigator Site
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Aalborg, Denmark
- Novartis Investigator Site
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Frederiksberg, Denmark
- Novartis Investigator Site
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Næstved, Denmark
- Novartis Investigator Site
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Roskilde, Denmark
- Novartis Investigator Site
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Sønderborg, Denmark
- Novartis Investigator Site
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Vaerlose, Denmark
- Novartis Investigator Site
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Viborg, Denmark
- Novartis Investigator Site
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Helsinki, Finland
- Novartis Investigator Site
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Jyväskylä, Finland
- Novartis Investigator Site
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Lahti, Finland
- Novartis Investigator Site
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OYS, Finland
- Novartis Investigator Site
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Pori, Finland
- Novartis Investigator Site
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Turku, Finland
- Novartis Investigator Site
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Ambroise, France
- Novartis Investigative Site
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Antibes, France
- Novartis Investigative Site
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Beuvry, France
- Novartis Investigator Site
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Ferolles-Attily, France
- Novartis Investigator Site
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Montpellier, France
- Novartis Investigative Site
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Nantes, France
- Novartis Investigator Site
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Nice, France
- Novartis Investigative Site
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Nimes, France
- Novartis Investigative Site
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Paris, France
- Novartis Investigative Site
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Paris, France
- Novartis Investigator Site
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Pessac, France
- Novartis Investigative Site
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Pierre Benite, France
- Novartis Investigator Site
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Suresnes, France
- Novartis Investigative Site
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Vandoeuvre Les Nancys, France
- Novartis Investigator Site
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Bergisch Gladbach, Germany
- Novartis Investigator Site
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Berlin, Germany
- Novartis Investigator Site
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Bochum, Germany
- Novartis Investigator Site
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Bonn, Germany
- Novartis Investigator Site
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Buchholz, Germany
- Novartis Investigator Site
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Coburg, Germany
- Novartis Investigator Site
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Dueren, Germany
- Novartis Investigator Site
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Eggenfelden, Germany
- Novartis Investigator Site
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Eschwege, Germany
- Novartis Investigator Site
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Euskirchen, Germany
- Novartis Investigator Site
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Freudenberg, Germany
- Novartis Investigator Site
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Fürth, Germany
- Novartis Investigator Site
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Gelsenkirchen, Germany
- Novartis Investigator Site
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Gummersbach, Germany
- Novartis Investigator Site
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Hagen, Germany
- Novartis Investigator Site
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Halle, Germany
- Novartis Investigator Site
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Hamburg, Germany
- Novartis Investigator Site
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Hannover, Germany
- Novartis Investigator Site
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Hoyerswerda, Germany
- Novartis Investigator Site
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Kassel, Germany
- Novartis Investigator Site
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Landsberg, Germany
- Novartis Investigative Site
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Leipzig, Germany
- Novartis Investigator Site
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Mainz, Germany
- Novartis Investigator Site
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Munich, Germany
- Novartis Investigator Site
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Oranienburg, Germany
- Novartis Investigator Site
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Radebeul, Germany
- Novartis Investigator Site
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Ratingen, Germany
- Novartis Investigator Site
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Ruhmannsfelden, Germany
- Novartis Investigator Site
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Rüsselsheim, Germany
- Novartis Investigator Site
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Solingen, Germany
- Novartis Investigator Site
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Stockach, Germany
- Novartis Investigator Site
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Teterow, Germany
- Novartis Investigator Site
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Vilshofen, Germany
- Novartis Investigator Site
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Wallerfing, Germany
- Novartis Investigator Site
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Wissen, Germany
- Novartis Investigator Site
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Athens, Greece
- Novartis Investigator Site
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Budapest, Hungary
- Novartis Investigative Site
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Budapest, Hungary
- Novartis Investigator Site
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Debrecen, Hungary
- Novartis Investigator Site
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Farkasgyepu, Hungary
- Novartis Investigative Site
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Godollo, Hungary
- Novartis Investigative Site
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Szolnok, Hungary
- Novartis Investigator Site
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Haifa, Israel
- Novartis Investigator Site
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Petach-Tikva, Israel
- Novartis Investigator Site
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Ancona, Italy
- Novartis Investigator Site
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Foggia, Italy
- Novartis Investigator Site
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Milano, Italy
- Novartis Investigative Site
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Milano, Italy
- Novartis Investigator Site
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Pavia, Italy
- Novartis Investigative Site
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Pavia, Italy
- Novartis Investigator Site
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Pisa, Italy
- Novartis Investigative Site
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Pisa, Italy
- Novartis Investigator Site
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Huxquilucan, Mexico
- Novartis Investigative Site
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Mexico City, Mexico
- Novartis Investigator Site
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San Luis Potosi, Mexico
- Novartis Investigative Site
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Drammen, Norway
- Novartis Investigator Site
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Follebu, Norway
- Novartis Investigator Site
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Kongsberg, Norway
- Novartis Investigative Site
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Kongsberg, Norway
- Novartis Investigator Site
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Kongsvinger, Norway
- Novartis Investigator Site
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Lierskogen, Norway
- Novartis Investigator Site
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Oslo, Norway
- Novartis Investigative Site
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Oslo, Norway
- Novartis Investigator Site
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Sandvika, Norway
- Novartis Investigator Site
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Skedsmokorset, Norway
- Novartis Investigative Site
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Stavanger, Norway
- Novartis Investigator Site
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Trondheim, Norway
- Novartis Investigative Site
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Trondheim, Norway
- Novartis Investigator Site
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Ålesund, Norway
- Novartis Investigative Site
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Ålesund, Norway
- Novartis Investigator Site
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Gdansk, Poland
- Novartis Investigator Site
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Katowice, Poland
- Novartis Investigator Site
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Krakow, Poland
- Novartis Investigative Site
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Krakow, Poland
- Novartis Investigator Site
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Piekary Slaskie, Poland
- Novartis Investigator Site
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Warszawa, Poland
- Novartis Investigator Site
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Wroclaw, Poland
- Novartis Investigator Site
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Barnaul, Russian Federation
- Novartis Investigator Site
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Ekaterinburg, Russian Federation
- Novartis Investigator Site
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Kazan, Russian Federation
- Novartis Investigator Site
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Novosibirsk, Russian Federation
- Novartis Investigator Site
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Petrozavodsk, Russian Federation
- Novartis Investigator Site
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Ryazan, Russian Federation
- Novartis Investigator Site
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Saint-Petersburg, Russian Federation
- Novartis Investigative Site
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Saint-Petersburg, Russian Federation
- Novartis Investigator Site
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Samara, Russian Federation
- Novartis Investigator Site
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Bratislava, Slovakia
- Novartis Investigator Site
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Kosice, Slovakia
- Novartis Investigative Site
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Kosice, Slovakia
- Novartis Investigator Site
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Kralovsky Chlmec, Slovakia
- Novartis Investigator Site
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Nitra, Slovakia
- Novartis Investigator Site
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Presov, Slovakia
- Novartis Investigative Site
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Zvolen, Slovakia
- Novartis Investigator Site
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Alcorcón, Spain
- Novartis Investigative Site
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Alicante, Spain
- Novartis Investigator Site
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Badalona, Spain
- Novartis Investigator Site
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Barcelona, Spain
- Novartis Investigative Site
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Begonte, Spain
- Novartis Investigative Site
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Burgos, Spain
- Novartis Investigator Site
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Caceres, Spain
- Novartis Investigator Site
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Canet de Mar, Spain
- Novartis Investigator Site
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Fuenlabrada, Spain
- Novartis Investigative Site
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Girona, Spain
- Novartis Investigative Site
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Madrid, Spain
- Novartis Investigative Site
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Mataro, Spain
- Novartis Investigator Site
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Plasencia, Spain
- Novartis Investigator Site
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Ponferrada, Spain
- Novartis Investigative Site
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Pontevedra, Spain
- Novartis Investigative Site
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Prat de Llobregat, Spain
- Novartis Investigator Site
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Santander, Spain
- Novartis Investigative Site
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Valencia, Spain
- Novartis Investigative Site
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Vila-real, Spain
- Novartis Investigative Site
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Basel, Switzerland
- Novartis Investigator Site
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Bellinzona, Switzerland
- Novartis Investigator Site
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Lugano, Switzerland
- Novartis Investigator Site
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Muenchenstein, Switzerland
- Novartis Investigator Site
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Zuerich, Switzerland
- Novartis Investigative Site
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Altunizade, Turkey
- Novartis Investigator Site
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Ankara, Turkey
- Novartis Investigator Site
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Aydin, Turkey
- Novartis Investigative Site
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Büyükçekmece / Ýstanbul, Turkey
- Novartis Investigator Site
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Fatih / Istanbul, Turkey
- Novartis Investigative Site
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Istanbul, Turkey
- Novartis Investigator Site
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Kahramanmaras, Turkey
- Novartis Investigator Site
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Mecidiyekoy/Istanbul, Turkey
- Novartis Investigative Site
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Mersin, Turkey
- Novartis Investigative Site
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Soke / Aydin, Turkey
- Novartis Investigative Site
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Yenisehir/Izmir, Turkey
- Novartis Investigative Site
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Ash Vale, United Kingdom
- Novartis Investigator Site
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Ashford, United Kingdom
- Novartis Investigator Site
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Bolton, United Kingdom
- Novartis Investigator Site
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Boscastle, United Kingdom
- Novartis Investigator Site
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Bradford, United Kingdom
- Novartis Investigator Site
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Chertsey, United Kingdom
- Novartis Investigator Site
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East Horsley, United Kingdom
- Novartis Investigator Site
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Newcastle-upon-Tyne, United Kingdom
- Novartis Investigator Site
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Plymouth, United Kingdom
- Novartis Investigator Site
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Watford, United Kingdom
- Novartis Investigator Site
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Alabama
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Birmingham, Alabama, United States, 35209
- Novartis Investigative Site
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Jasper, Alabama, United States, 35501
- Novartis Investigator Site
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Arizona
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Phoenix, Arizona, United States, 85050
- Novartis Investigative Site
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Tucson, Arizona, United States, 85723
- Novartis Investigative Site
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California
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Anaheim, California, United States, 92801
- Novartis Investigator Site
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Stockton, California, United States, 95207
- Novartis Investigator Site
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Walnut Creek, California, United States, 94598
- Novartis Investigator Site
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Colorado
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Fort Collins, Colorado, United States, 80528
- Novartis Investigator Site
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Wheat Ridge, Colorado, United States, 80033
- Novartis Investigator Site
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Florida
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South Miami, Florida, United States, 33143
- Novartis Investigative Site
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Illinois
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Normal, Illinois, United States, 61761
- Novartis Investigator Site
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Indiana
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Evansville, Indiana, United States, 47710
- Novartis Investigative Site
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Kansas
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Topeka, Kansas, United States, 66606
- Novartis Investigative Site
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Louisiana
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Lafayette, Louisiana, United States, 70503
- Novartis Investigative Site
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Missouri
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St Charles, Missouri, United States, 63301
- Novartis Investigative Center
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St Louis, Missouri, United States, 63141
- Novartis Investigative Site
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Novartis Investigative Site
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Nevada
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Henderson, Nevada, United States, 89014
- Novartis Investigative Site
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New York
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Albany, New York, United States, 12205
- Novartis Investigative Site
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Larchmont, New York, United States, 10538
- Novartis Investigative Site
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New York, New York, United States, 10016
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Novartis Investigative Site
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Ohio
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Columbus, Ohio, United States, 43214
- Novartis Investigative Site
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Texas
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San Antonio, Texas, United States, 78229
- Novartis Investigative Site
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Virginia
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Richmond, Virginia, United States, 23229
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- a) Smoking history of at least 10 pack-years
- b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
- c) Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Exclusion Criteria:
- Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
- 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 applied to the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Indacaterol 150 µg
Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning.
Participants were permitted to take salbutamol/albuterol as a rescue medication.
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Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
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ACTIVE_COMPARATOR: Tiotropium 18 µg
Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning.
Participants were permitted to take salbutamol/albuterol as a rescue medication.
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Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)
Time Frame: End of treatment (Week 12)
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Spirometry was conducted according to internationally accepted standards.
Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings.
Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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End of treatment (Week 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
Time Frame: 5 minutes to 4 hours post-dose at the end of treatment (week 12)
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Spirometry was conducted according to internationally accepted standards.
FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1.
Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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5 minutes to 4 hours post-dose at the end of treatment (week 12)
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Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment
Time Frame: 12 weeks
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TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort.
Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline.
A 1 unit difference in the TDI focal score is clinically significant.
Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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12 weeks
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Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Time Frame: 12 weeks
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SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease).
The total score is 0 to 100 with a higher score indicating greater impairment of health status.
Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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12 weeks
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Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Time Frame: Baseline, up to 12 weeks
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Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary.
The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant.
Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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Baseline, up to 12 weeks
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Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Time Frame: Baseline, up to 12 weeks
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Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary.
The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant.
Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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Baseline, up to 12 weeks
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Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)
Time Frame: Baseline, up to 12 weeks
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Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary.
The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant.
Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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Baseline, up to 12 weeks
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Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment
Time Frame: Up to 12 weeks
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A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication.
The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100.
Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.
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Up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
May 12, 2009
First Submitted That Met QC Criteria
May 12, 2009
First Posted (ESTIMATE)
May 13, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
Other Study ID Numbers
- CQAB149B2350
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Indacaterol 150 μg
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Novartis PharmaceuticalsCompletedAsthmaSouth Africa, Belgium, Croatia, Turkey, Hungary, Colombia, Slovakia, Philippines, Russian Federation, Guatemala, Germany
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NovartisCompletedChronic Obstructive Pulmonary DiseaseJapan
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Novartis PharmaceuticalsCompletedChronic Obstructive Pulmonary Disease (COPD)Taiwan, Korea, Republic of, Japan, India, Hong Kong, Singapore
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Novartis PharmaceuticalsCompletedChronic Obstructive Pulmonary Disease (COPD)China, Australia, India
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NovartisCompletedChronic Obstructive Pulmonary DiseaseUnited States, New Zealand, Belgium
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Novartis PharmaceuticalsCompletedAsthmaGermany, Netherlands, United Kingdom
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Alebund PharmaceuticalsNot yet recruiting
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Novartis PharmaceuticalsCompleted
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Alebund Pty LtdCompletedHealthy SubjectsAustralia
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Novartis PharmaceuticalsCompletedMild AsthmaGermany, India, Korea, Republic of, Poland, South Africa, Estonia, Italy, Russian Federation, Thailand, Latvia, Lithuania, Colombia, Hungary, Peru, Philippines, Slovakia, Bulgaria, Vietnam, Japan, Malaysia, Chile, Sweden