NCT00557466

A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	indacaterol	Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
DRUG	formoterol	Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
DRUG	placebo to indacaterol	Placebo TWISTHALER® device
DRUG	placebo to formoterol	Placebo AEROLIZER® device
DRUG	short acting β2- agonist	100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-11-14
• Last updated: 2013-01-18
• Results posted: 2013-01-18

Locations

75 sites across 17 countries: Argentina, Belgium, Chile, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Norway, Peru, Poland, Romania, South Africa, Turkey (Türkiye), United Kingdom