drugset / Trial / NCT00403286

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

NCT00403286

Phase 2 Completed 457 enrolled Dey
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-11
Primary completion
2007-05
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 250 ug Inhaled
Subject Fluticasone propionate Other / unclassified 500 ug Inhaled
Subject Fluticasone propionate Other / unclassified 1000 ug Inhaled
Subject Formoterol Other / unclassified 10 ug Inhaled
Subject Formoterol Other / unclassified 20 ug Inhaled
Comparator salmeterol xinafoate Unknown 50 ug Inhaled