Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

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, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; 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 (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Official Title
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Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma

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: Outpatients Written informed consent History of bronchial asthma for at least 6 months Good health with the exception of asthma Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent FEV1 80 - 105% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Current smoking with more than 10 pack-years Previous smoking with more than 10 pack-years Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times 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: 12 Years
Maximum Age: 75 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 |  |  | 
| time to the first asthma exacerbation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC |  |  | 
| asthma symptom score |  |  | 
| use of rescue medication |  |  | 
| AQLQ(S) and EQ-5D |  |  | 
| percentage of days on which patients perceived asthma control |  |  | 
| percentage of nocturnal awakening-free days |  |  | 
| percentage of rescue medication-free days |  |  | 
| percentage of asthma symptom-free days |  |  | 
| physical examination |  |  | 
| vital signs |  |  | 
| standard laboratory work-up |  |  | 
| adverse events |  |  | 
| number of patients with local oropharyngeal adverse events. |  |  | 

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