drugset / Trial / NCT00163293

Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)

NCT00163293

Phase 3 Completed 240 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.

Timeline

Start
2005-01-01
Primary completion
2009-06-01
Completion
2010-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciclesonide Other / unclassified 100 ug Inhaled
Comparator Ciclesonide Other / unclassified 200 ug Inhaled

Indications