A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00900731

Run by

Novartis Pharmaceuticals

People needed

1598

Starts

2009-06-01

Expected to finish

2010-03-01

Last updated by the study team

2011-08-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• 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 Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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