Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)
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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.
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
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main inclusion criteria:
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