Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

Study Overview
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Brief Summary
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The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Official Title
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Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: History of persistent bronchial asthma for at least 6 months FEV1 50-90% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study History of life-threatening asthma Premature birth Current smoking Smoking history with either equal or more than 10 pack-years Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ciclesonide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 absolute values |  |  | 
| PD20FEV1 from methacholine challenge. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 as % of predicted |  |  | 
| PEF from spirometry |  |  | 
| morning and evening PEF from diary |  |  | 
| asthma symptom score from diary |  |  | 
| salbutamol MDI use from diary |  |  | 
| diurnal PEF fluctuation from diary |  |  | 
| dropout rate due to asthma exacerbations and time to the first asthma exacerbation |  |  | 
| percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control |  |  | 
| onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication |  |  | 
| interview administered PAQLQ(S), self-administered PACQLQ |  |  | 
| physical examination and vital signs |  |  | 
| laboratory investigation |  |  | 
| AEs |  |  | 
| HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples. |  |  | 

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