drugset / Trial / NCT00535366

Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

NCT00535366

Phase 2 Completed 103 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

Summary

This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

Timeline

Start
2007-10
Primary completion
2008-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciclesonide Other / unclassified 400 ug Inhaled
Subject Ciclesonide Other / unclassified 800 ug Inhaled
Subject Fluticasone Other / unclassified 500 ug Inhaled
Background Salmeterol Other / unclassified 50 ug Inhaled
Background Tiotropium Other / unclassified 18 ug Inhaled