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
323 participants
INTERVENTIONAL
2010-01-31
2010-07-31
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 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00624286
Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
NCT01068600
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT00620022
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
NCT01089127
Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01543828
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Indacaterol 75 μg
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Indacaterol 75 μg
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to indacaterol
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indacaterol 75 μg
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Smoking history of at least 10 pack-years
* Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
* 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
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 Investigator Site
Peoria, Arizona, United States
Novartis Investigator Site
Pine Bluff, Arkansas, United States
Novartis Investigator Site
Buena Park, California, United States
Novartis Investigator Site
Encinitas, California, United States
Novartis Investigator Site
Fountain Valley, California, United States
Novartis Investigator Site
Los Angeles, California, United States
Novartis Investigator Site
San Diego, California, United States
Novartis Investigator Site
San Diego, California, United States
Novartis Investigator Site
Temecula, California, United States
Novartis Investigator Site
Torrance, California, United States
Novartis Investigator Site
Walnut Creek, California, United States
Novartis Investigator Site
Wheat Ridge, Colorado, United States
Novartis Investigative Site
Port Orange, Florida, United States
Novartis Investigative Site
Sarasota, Florida, United States
Novartis Investigative Site
Tamarac, Florida, United States
Novartis Investigator Site
Couer D'Alene, Idaho, United States
Novartis Investigator Site
Champaign, Illinois, United States
Novartis Investigator Site
Downers Grove, Illinois, United States
Novartis Investigative Site
River Forest, Illinois, United States
Novartis Investigator Site
Skokie, Illinois, United States
Novartis Investigator Site
Springfield, Illinois, United States
Novartis Investigative site
Lexington, Kentucky, United States
Novartis Investigator Site
Covington, Louisiana, United States
Novartis Investigator Site
Metaire, Louisiana, United States
Novartis Investigative Site
Bangor, Maine, United States
Novartis Investigative Site
Columbia, Maryland, United States
Novartis Investigative Site
Clarkston, Michigan, United States
Novartis Investigative Site
Flint, Michigan, United States
Novartis Investigative Site
Livonia, Michigan, United States
Novartis Investigative Site
Edina, Minnesota, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
Plymouth, Minnesota, United States
Novartis Investigator Site
Florissant, Missouri, United States
Novartis Investigator Site
Ozark, Missouri, United States
Novartis Investigator Site
St Louis, Missouri, United States
Novartis Investigative Site
Missoula, Montana, United States
Novartis Investigator Site
Bellevue, Nebraska, United States
Novartis Investigator Site
Lincoln, Nebraska, United States
Novartis Investigator Site
Omaha, Nebraska, United States
Novartis Investigator Site
Henderson, Nevada, United States
Novartis Investigator Site
Pahrump, Nevada, United States
Novartis Investigative Site
New Brunswick, New Jersey, United States
Novartis Investigative Site
Ocean City, New Jersey, United States
Novartis Investigative Site
Rochester, New York, United States
Novartis Investigative Site
Charlotte, North Carolina, United States
Novartis Investigative Site
Salisbury, North Carolina, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigator Site
Medford, Oregon, United States
Novartis Investigative Site
Beaver, Pennsylvania, United States
Novartis Investigative Site
Erie, Pennsylvania, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Gaffney, South Carolina, United States
Novartis Investigative site
Greer, South Carolina, United States
Novartis Investigative Site
Seneca, South Carolina, United States
Novartis Investigative Site
Johnson City, Tennessee, United States
Novartis Investigator Site
Corsicana, Texas, United States
Novartis Investigator Site
Fort Worth, Texas, United States
Novartis Investigator Site
Salt Lake City, Utah, United States
Novartis Investigator Site
Abingdon, Virginia, United States
Novartis Investigative Site
Newport News, Virginia, United States
Novartis Investigator Site
Tacoma, Washington, United States
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.
Gotfried MH, Kerwin EM, Lawrence D, Lassen C, Kramer B. Efficacy of indacaterol 75 mug once-daily on dyspnea and health status: results of two double-blind, placebo-controlled 12-week studies. COPD. 2012 Dec;9(6):629-36. doi: 10.3109/15412555.2012.729623. Epub 2012 Sep 28.
Kerwin EM, Gotfried MH, Lawrence D, Lassen C, Kramer B. Efficacy and tolerability of indacaterol 75 mug once daily in patients aged >/=40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies. Clin Ther. 2011 Dec;33(12):1974-84. doi: 10.1016/j.clinthera.2011.11.009.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CQAB149B2354
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.