NCT00615459

A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Indacaterol	Indacaterol 150 μg or 300 μg, delivered via SDDPI
DRUG	Tiotropium	Tiotropium 18 μg once daily delivered via inhalation device
DRUG	Placebo	Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-02-14
• Last updated: 2011-08-17
• Results posted: 2011-08-17

Locations

20 sites across 7 countries: Australia, Germany, Netherlands, New Zealand, Poland, South Africa, Spain