A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00900731
Last Updated: 2011-08-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1598 participants
INTERVENTIONAL
2009-06-30
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
NCT00877383
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
NCT00846586
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
NCT00999908
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00463567
A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
NCT00615459
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Indacaterol 150 μg
Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Placebo to tiotropium
Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
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.
Tiotropium 18 μg
Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
Placebo to indacaterol
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indacaterol 150 μg
Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Tiotropium 18 μg
Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
Placebo to indacaterol
Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Placebo to tiotropium
Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Novartis Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigator Site
Jasper, Alabama, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigator Site
Anaheim, California, United States
Novartis Investigator Site
Stockton, California, United States
Novartis Investigator Site
Walnut Creek, California, United States
Novartis Investigator Site
Fort Collins, Colorado, United States
Novartis Investigator Site
Wheat Ridge, Colorado, United States
Novartis Investigative Site
South Miami, Florida, United States
Novartis Investigator Site
Normal, Illinois, United States
Novartis Investigative Site
Evansville, Indiana, United States
Novartis Investigative Site
Topeka, Kansas, United States
Novartis Investigative Site
Lafayette, Louisiana, United States
Novartis Investigative Center
Saint Charles, Missouri, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Lincoln, Nebraska, United States
Novartis Investigative Site
Henderson, Nevada, United States
Novartis Investigative Site
Albany, New York, United States
Novartis Investigative Site
Larchmont, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Charlotte, North Carolina, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Richmond, Virginia, United States
Novartis Investigator Site
Feldbach, , Austria
Novartis Investigator Site
Gänserndorf, , Austria
Novartis Investigator Site
Hallein, , Austria
Novartis Investigator Site
Brussels, , Belgium
Novartis Investigator Site
Gilly, , Belgium
Novartis Investigator Site
Jambes, , Belgium
Novartis Investigator Site
Jette, , Belgium
Novartis Investigator Site
Liège, , Belgium
Novartis Investigator Site
Montigny-le-Tilleul, , Belgium
Novartis Investigator Site
Ostend, , Belgium
Novartis Investigator Site
Sankt Vith, , Belgium
Novartis Investigator Site
Yvoir, , Belgium
Novartis Investigator Site
Calgary, , Canada
Novartis Investigative Site
Greater Sudbury, , Canada
Novartis Investigative Site
Mississauga, , Canada
Novartis Investigative Site
Moncton, , Canada
Novartis Investigative Site
New Market, , Canada
Novartis Investigative SIte
Québec, , Canada
Novartis Investigative Site
Saint Romuald, , Canada
Novartis Investigator Site
Barranquilla, , Colombia
Novartis Investigator Site
Bogotá, , Colombia
Novartis Investigator Site
Medellín, , Colombia
Novartis Investigator Site
Aalborg, , Denmark
Novartis Investigator Site
Frederiksberg, , Denmark
Novartis Investigator Site
Næstved, , Denmark
Novartis Investigator Site
Roskilde, , Denmark
Novartis Investigator Site
Sønderborg, , Denmark
Novartis Investigator Site
Viborg, , Denmark
Novartis Investigator Site
Værløse, , Denmark
Novartis Investigator Site
Helsinki, , Finland
Novartis Investigator Site
Jyväskylä, , Finland
Novartis Investigator Site
Lahti, , Finland
Novartis Investigator Site
OYS, , Finland
Novartis Investigator Site
Pori, , Finland
Novartis Investigator Site
Turku, , Finland
Novartis Investigative Site
Ambroise, , France
Novartis Investigative Site
Antibes, , France
Novartis Investigator Site
Beuvry, , France
Novartis Investigator Site
Ferolles-Attily, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigator Site
Nantes, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Nîmes, , France
Novartis Investigative Site
Paris, , France
Novartis Investigator Site
Paris, , France
Novartis Investigative Site
Pessac, , France
Novartis Investigator Site
Pierre-Bénite, , France
Novartis Investigative Site
Suresnes, , France
Novartis Investigator Site
Vandoeuvre Les Nancys, , France
Novartis Investigator Site
Bergisch Gladbach, , Germany
Novartis Investigator Site
Berlin, , Germany
Novartis Investigator Site
Bochum, , Germany
Novartis Investigator Site
Bonn, , Germany
Novartis Investigator Site
Buchholz, , Germany
Novartis Investigator Site
Coburg, , Germany
Novartis Investigator Site
Düren, , Germany
Novartis Investigator Site
Eggenfelden, , Germany
Novartis Investigator Site
Eschwege, , Germany
Novartis Investigator Site
Euskirchen, , Germany
Novartis Investigator Site
Freudenberg, , Germany
Novartis Investigator Site
Fürth, , Germany
Novartis Investigator Site
Gelsenkirchen, , Germany
Novartis Investigator Site
Gummersbach, , Germany
Novartis Investigator Site
Hagen, , Germany
Novartis Investigator Site
Halle, , Germany
Novartis Investigator Site
Hamburg, , Germany
Novartis Investigator Site
Hanover, , Germany
Novartis Investigator Site
Hoyerswerda, , Germany
Novartis Investigator Site
Kassel, , Germany
Novartis Investigative Site
Landsberg, , Germany
Novartis Investigator Site
Leipzig, , Germany
Novartis Investigator Site
Mainz, , Germany
Novartis Investigator Site
Munich, , Germany
Novartis Investigator Site
Oranienburg, , Germany
Novartis Investigator Site
Radebeul, , Germany
Novartis Investigator Site
Ratingen, , Germany
Novartis Investigator Site
Ruhmannsfelden, , Germany
Novartis Investigator Site
Rüsselsheim am Main, , Germany
Novartis Investigator Site
Solingen, , Germany
Novartis Investigator Site
Stockach, , Germany
Novartis Investigator Site
Teterow, , Germany
Novartis Investigator Site
Vilshofen, , Germany
Novartis Investigator Site
Wallerfing, , Germany
Novartis Investigator Site
Wissen, , Germany
Novartis Investigator Site
Athens, , Greece
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigator Site
Budapest, , Hungary
Novartis Investigator Site
Debrecen, , Hungary
Novartis Investigative Site
Farkasgyepű, , Hungary
Novartis Investigative Site
Gödöllő, , Hungary
Novartis Investigator Site
Szolnok, , Hungary
Novartis Investigator Site
Haifa, , Israel
Novartis Investigator Site
Petah Tikva, , Israel
Novartis Investigator Site
Ancona, , Italy
Novartis Investigator Site
Foggia, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigator Site
Milan, , Italy
Novartis Investigative Site
Pavia, , Italy
Novartis Investigator Site
Pavia, , Italy
Novartis Investigative Site
Pisa, , Italy
Novartis Investigator Site
Pisa, , Italy
Novartis Investigative Site
Huxquilucan, , Mexico
Novartis Investigator Site
Mexico City, , Mexico
Novartis Investigative Site
San Luis Potosí City, , Mexico
Novartis Investigative Site
Ålesund, , Norway
Novartis Investigator Site
Ålesund, , Norway
Novartis Investigator Site
Drammen, , Norway
Novartis Investigator Site
Follebu, , Norway
Novartis Investigative Site
Kongsberg, , Norway
Novartis Investigator Site
Kongsberg, , Norway
Novartis Investigator Site
Kongsvinger, , Norway
Novartis Investigator Site
Lierskogen, , Norway
Novartis Investigative Site
Oslo, , Norway
Novartis Investigator Site
Oslo, , Norway
Novartis Investigator Site
Sandvika, , Norway
Novartis Investigative Site
Skedsmokorset, , Norway
Novartis Investigator Site
Stavanger, , Norway
Novartis Investigative Site
Trondheim, , Norway
Novartis Investigator Site
Trondheim, , Norway
Novartis Investigator Site
Gdansk, , Poland
Novartis Investigator Site
Katowice, , Poland
Novartis Investigative Site
Krakow, , Poland
Novartis Investigator Site
Krakow, , Poland
Novartis Investigator Site
Piekary Śląskie, , Poland
Novartis Investigator Site
Warsaw, , Poland
Novartis Investigator Site
Wroclaw, , Poland
Novartis Investigator Site
Barnaul, , Russia
Novartis Investigator Site
Kazan', , Russia
Novartis Investigator Site
Novosibirsk, , Russia
Novartis Investigator Site
Petrozavodsk, , Russia
Novartis Investigator Site
Ryazan, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigator Site
Saint Petersburg, , Russia
Novartis Investigator Site
Samara, , Russia
Novartis Investigator Site
Yekaterinburg, , Russia
Novartis Investigator Site
Bratislava, , Slovakia
Novartis Investigative Site
Košice, , Slovakia
Novartis Investigator Site
Košice, , Slovakia
Novartis Investigator Site
Kráľovský Chlmec, , Slovakia
Novartis Investigator Site
Nitra, , Slovakia
Novartis Investigative Site
Prešov, , Slovakia
Novartis Investigator Site
Zvolen, , Slovakia
Novartis Investigative Site
Alcorcón, , Spain
Novartis Investigator Site
Alicante, , Spain
Novartis Investigator Site
Badalona, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Begonte, , Spain
Novartis Investigator Site
Burgos, , Spain
Novartis Investigator Site
Canet de Mar, , Spain
Novartis Investigator Site
Cáceres, , Spain
Novartis Investigator Site
el Prat de Llobregat, , Spain
Novartis Investigative Site
Fuenlabrada, , Spain
Novartis Investigative Site
Girona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigator Site
Mataró, , Spain
Novartis Investigator Site
Plasencia, , Spain
Novartis Investigative Site
Ponferrada, , Spain
Novartis Investigative Site
Pontevedra, , Spain
Novartis Investigative Site
Santander, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Vila-real, , Spain
Novartis Investigator Site
Basel, , Switzerland
Novartis Investigator Site
Bellinzona, , Switzerland
Novartis Investigator Site
Lugano, , Switzerland
Novartis Investigator Site
Muenchenstein, , Switzerland
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigator Site
Altunizade, , Turkey (Türkiye)
Novartis Investigator Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Aydin, , Turkey (Türkiye)
Novartis Investigator Site
Büyükçekmece / Ýstanbul, , Turkey (Türkiye)
Novartis Investigative Site
Fatih / Istanbul, , Turkey (Türkiye)
Novartis Investigator Site
Istanbul, , Turkey (Türkiye)
Novartis Investigator Site
Kahramanmaraş, , Turkey (Türkiye)
Novartis Investigative Site
Mecidiyekoy/Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Mersin, , Turkey (Türkiye)
Novartis Investigative Site
Soke / Aydin, , Turkey (Türkiye)
Novartis Investigative Site
Yenisehir/Izmir, , Turkey (Türkiye)
Novartis Investigator Site
Ash Vale, , United Kingdom
Novartis Investigator Site
Ashford, , United Kingdom
Novartis Investigator Site
Bolton, , United Kingdom
Novartis Investigator Site
Boscastle, , United Kingdom
Novartis Investigator Site
Bradford, , United Kingdom
Novartis Investigator Site
Chertsey, , United Kingdom
Novartis Investigator Site
East Horsley, , United Kingdom
Novartis Investigator Site
Newcastle upon Tyne, , United Kingdom
Novartis Investigator Site
Plymouth, , United Kingdom
Novartis Investigator Site
Watford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Buhl R, Dunn LJ, Disdier C, Lassen C, Amos C, Henley M, Kramer B; INTENSITY study investigators. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J. 2011 Oct;38(4):797-803. doi: 10.1183/09031936.00191810. Epub 2011 May 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CQAB149B2350
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.