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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ciclesonide

Criteria

Main Inclusion Criteria:

• Written informed consent by the parents or legal guardians of the patient

• Outpatients

• Good health with the exception of asthma

• Documented diagnosis of asthma for more than 6 months

• Use of rescue medication only or pretreatment with a controller drug

Main Exclusion Criteria:

• Concomitant severe diseases

• Diseases contraindicated for the use of inhaled steroids

• Other relevant lung diseases causing impairment in pulmonary function

• Recurrent, episodic wheezing only

• History of life-threatening asthma

• History of any mechanical ventilation

• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation

• Premature birth (< 32 weeks gestation)