NCT00615030

Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Indacaterol	300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
DRUG	Salmeterol	50 µg twice daily delivered via dry powder inhaler (DPI)
DRUG	Placebo to Indacaterol	Placebo matching indacaterol was delivered via SDDPI.
DRUG	Placebo to Salmeterol	Placebo matching salmeterol was delivered via DPI

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2008-02-14
• Last updated: 2011-08-17
• Results posted: 2011-08-17

Locations

7 sites across 3 countries: France, Germany, Spain