NCT00393458

Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control

A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,732 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Indacaterol	Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
DRUG	Formoterol	Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).
DRUG	Placebo to indacaterol	Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
DRUG	Placebo to formoterol	Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-10-27
• Last updated: 2011-08-18
• Results posted: 2011-08-18

Locations

183 sites across 25 countries: Argentina, Chile, Colombia, Czechia, Denmark, Ecuador, Egypt, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Peru, Romania, Russia, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom