Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)

Study Overview
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Brief Summary
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The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.

Official Title
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ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide/Formoterol Combination


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Written informed consent Good health with the exception of bronchial asthma (for at least 6 months) FEV1 > 60% to < 80% of predicted (if pretreated with inhaled steroids only) FEV1 > 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller) Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years Use of other drugs not allowed Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential

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/Formoterol Combination|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first experience of lack of efficacy |  |  | 
| AUC (FEV1) over a 24 h dosing interval. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 |  |  | 
| morning and evening PEF, asthma symptoms and use of rescue medication |  |  | 
| proportion of patients with a clinical asthma exacerbation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Ciclesonide, Formoterol Fumarate, Long-acting beta2-agonists, LABA, Steroids