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

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

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.

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