NCT00677807

Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Indacaterol	Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
DRUG	Placebo	Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-05-15
• Last updated: 2011-08-22
• Results posted: 2011-08-18

Locations

190 sites across 9 countries: United States, Argentina, Canada, Germany, India, Italy, Spain, Sweden, Turkey (Türkiye)