drugset / Trial / NCT00163449

Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

NCT00163449

Phase 3 Completed 1000 enrolled AstraZeneca
RandomizedParallel-groupTriple-blind

Summary

The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Timeline

Start
2005-11
Primary completion
2006-11
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciclesonide Other / unclassified 40 ug Inhaled
Comparator Ciclesonide Other / unclassified 80 ug Inhaled
Comparator Ciclesonide Other / unclassified 160 ug Inhaled

Indications