NCT00669617

Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Indacaterol	Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
DRUG	Salmeterol/fluticasone (50/500 μg)	Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
DRUG	Salbutamol (200 µg)	Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
DRUG	Placebo to Indacaterol	Placebo to indacaterol delivered via SDDPI
DRUG	Placebo to Salmeterol/fluticasone	Placebo to salmeterol/fluticasone delivered via MDDPI
DRUG	Placebo to salbutamol	Placebo to salbutamol delivered via MDDPI

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-04-30
• Last updated: 2011-09-12
• Results posted: 2011-08-17

Locations

17 sites across 4 countries: United States, Belgium, Germany, Hungary