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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Time to the first experience of lack of efficacy
AUC (FEV1) over a 24 h dosing interval.

Secondary Outcome Measures

Name	Time	Method
FEV1
proportion of patients with a clinical asthma exacerbation.
morning and evening PEF, asthma symptoms and use of rescue medication

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