NCT00567996

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,002 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Indacaterol 150 μg	Indacaterol 150 μg once daily (o.d) inhaled
DRUG	Salmeterol 50 μg	Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
DRUG	Placebo to Indacaterol	Placebo to Indacaterol inhaled via SDDPI.
DRUG	Placebo to Salmeterol	Placebo to salmeterol delivered via a proprietary dry powder inhaler

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-01-01
• First posted: 2007-12-05
• Last updated: 2011-08-18
• Results posted: 2011-08-18

Locations

128 sites across 15 countries: Canada, Colombia, Czechia, Denmark, Finland, France, Germany, Hungary, Iceland, India, Italy, Peru, Russia, Slovakia, Taiwan