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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent 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: Written informed consent History of bronchial asthma for at least 6 months Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination FEV1 ≥ 80% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs COPD Smoking with ≥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: 18 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 |
| --- | --- | --- |
| number of patients with candidiasis of the oropharynx or hoarseness. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inhaled Corticosteroids Questionnaire (ICQ) |  |  | 
| proportion of cases of candidiasis of the oropharynx or |  |  | 
| hoarseness at each visit Secondary variables |  |  | 
| FEV1, FVC, PEF from spirometry |  |  | 
| morning and evening PEF from diaries |  |  | 
| diurnal PEF fluctuation |  |  | 
| onset of treatment effect |  |  | 
| percent days on which patient perceived asthma control |  |  | 
| percent of nocturnal awakening-free days |  |  | 
| percent of rescue medication free days |  |  | 
| percent symptom free days |  |  | 
| asthma symptom score |  |  | 
| use of rescue medication |  |  | 
| time to first asthma exacerbation |  |  | 
| number of patients with an asthma exacerbation |  |  | 
| AQLQ |  |  | 
| number of patients with candidiasis of the oropharynx or hoarseness by severity |  |  | 
| physical examination, ECG |  |  | 
| vital sings |  |  | 
| adverse events |  |  | 
| standard laboratory work-up |  |  | 
| morning serum cortisol |  |  | 
| skin bruising. |  |  | 

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