NCT00463567

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, 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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,059 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Conditions

• Pulmonary Disease, Chronic Obstructive
• COPD
• Lung Diseases, Obstructive

Interventions

Type	Name	Description
DRUG	Indacaterol	In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
DRUG	Formoterol (12 µg b.i.d.)	Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
DRUG	Tiotropium (18 µg o.d.)	Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
DRUG	Placebo to Indacaterol	In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
DRUG	Placebo to Formoterol	In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-04-20
• Last updated: 2011-08-18
• Results posted: 2011-08-18

Locations

344 sites across 12 countries: United States, Argentina, Canada, Germany, India, Italy, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye)