NCT00403845

Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, and 600 µg) Delivered Via a Single Dose Dry Powder Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Indacaterol 150 μg	Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
DRUG	Indacaterol 300 μg	Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
DRUG	Placebo	Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-11-27
• Last updated: 2011-08-17
• Results posted: 2011-08-17

Locations

8 sites across 1 country: Japan