NCT00403286

A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Dey · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate/Formoterol Fumarate	Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
DRUG	Fluticasone Propionate/Formoterol Fumarate	Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
DRUG	Fluticasone Propionate/Formoterol Fumarate	Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
DRUG	Fluticasone Propionate/Formoterol Fumarate	Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
DRUG	Fluticasone Propionate	Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
DRUG	Formoterol Fumarate	Inhalation Solution for nebulization 20 mcg bid for 2 weeks
DRUG	Fluticasone Propionate/Salmeterol Xinafoate	Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
DRUG	Placebo	Inhalation Solution for nebulization 2 mL bid for 2 weeks

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-11-23
• Last updated: 2009-06-30

Locations

49 sites across 1 country: United States