drugset / Trial / NCT00163319

Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

NCT00163319

Phase 3 Completed 500 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Timeline

Start
2004-11
Primary completion
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ciclesonide Other / unclassified 640 ug Inhaled

Indications