Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)

Study Overview
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Brief Summary
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Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.

Official Title
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A 3-period Double-blind, Cross-over Study on the Onset of Action of Inhaled Ciclesonide (7 Days of 400 mcg Sid Versus 800 mcg Bid Versus Placebo) on Airway Responsiveness to Adenosine Monophosphate (AMP), Sputum Eosinophiles and Exhaled Breath Nitric Oxide (NO) in Patients With 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: Out-patients Written informed consent History of atopic disease History of perennial bronchial asthma for at least 6 months as defined by ATS criteria Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0) Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start FEV1 ≥ 70% predicted Hyperreactivity to AMP (PC20FEV1 < 25 mg/ml) Good health with the exception of asthma Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence Main exclusion criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis) Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers Immunotherapy within one month prior to B0 and/or during the entire study duration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Crossover 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 |
| --- | --- | --- |
| PC20FEV1 (AMP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline FEV1 from spirometry, exhaled NO, eosinophils, basophils, and mast cells determined from induced sputum; Safety variables: Physical examination, vital signs, ECG, laboratory work-up, and adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Ciclesonide, Airway hyperresponsiveness, Sputum, Nitric oxide