drugset / Trial / NCT00163410

Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)

NCT00163410

Phase 3 Completed 500 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Timeline

Start
2003-04
Primary completion
2004-12
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciclesonide Other / unclassified 200 ug Inhaled

Indications