Trial Information

Summary: Researchers want to find out if an ivestigational drug, indacaterol, can help people with COPD (chronic obstructive lung disease).

A 26-week treatment, multicenter, randomized, double-blind, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of two doses of indacaterol (selected from 75, 150, 300 & 600 µg o.d.) in patients with chronic obstructive pulmonary disease using blinded formoterol (12 µg b.i.d) and open label tiotropium (18 µg o.d.) as active controls

COPD is a disease of the lung that causes people to suffer such symptoms as shortness of breath and coughing. Researchers want to find out if an investigational drug called indacaterol can help people with COPD. Indacaterol is an investigational drug. An “investigational drug” is a drug that is being tested and is not yet approved for sale by the FDA. This study is being done to see if indacaterol can help people with their COPD.

Inclusion Criteria

• Males and females age 40 and older
• Clinical diagnosis of COPD

Exclusion Criteria

• Tuberculosis
• Asthma
• Type 1 Diabetes
• Uncontrolled Type 2 Diabetes
• History of lung cancer

Primary Outcomes: To demonstrate superiority of at least one dose of indacterol to placebo at 24 hours post dose after 12 weeks of treatment by spirometry.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.