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

Study Overview
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Brief Summary
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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.

Official Title
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BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ciclesonide 40 µg | Drug: Ciclesonide<br>* Efficacy and Safety of Ciclesonide<br>|
| Active Comparator: 2<br>Ciclesonide 80 µg | Drug: Ciclesonide<br>* Efficacy and Safety of Ciclesonide<br>|
| Active Comparator: 3<br>Ciclesonide 160 µg | Drug: Ciclesonide<br>* Efficacy and Safety of Ciclesonide<br>|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first moderate or severe asthma exacerbation. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients with moderate or severe asthma exacerbation |  | 24 weeks | 
| rate of patients with moderate asthma exacerbation |  | 24 weeks | 
| rate of patients with severe asthma exacerbation |  | 24 weeks | 
| time to first moderate asthma exacerbation |  | 24 weeks | 
| time to first severe asthma exacerbation |  | 24 weeks | 
| asthma symptom score from diary |  | 24 weeks | 
| use of rescue medication |  | 24 weeks | 
| patient perceived asthma control |  | 24 weeks | 
| quality of life data (PACQLQ) |  | 24 weeks | 
| morning and evening PEF from diary |  | 24 weeks | 
| pulmonary function variables measured at the investigational sites |  | 24 weeks | 
| adverse events |  | 24 weeks | 
| physical examination |  | 24 weeks | 
| vital signs |  | 24 weeks | 
| laboratory work-up |  | 24 weeks | 
| serum cortisol |  | 24 weeks | 
| urine cortisol variables |  | 24 weeks | 
| body growth determined by stadiometry. |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Ciclesonide, Child, Pediatric