Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid
Asthma
About this trial
This is an interventional treatment trial for Asthma focused on measuring Glucocorticosteroid. Bronchospasm
Eligibility Criteria
Inclusion Criteria: Males or females 12 years or older History of persistent bronchial asthma for at least 6 months Documented use of an inhaled steroid or a combination of an inhaled steroid/long-acting beta 2 agonist for at least 1 month before screening At screening, FEV1 of 60 to 90% predicted or 70 to 95% predicted for either ICS or ICS/LABA use respectively.Reversibility of FEV1 by at least 12% and 200 ml post-bronchodilator Be able to use oral inhalers Non-smokers Exclusion Criteria: History of life-threatening asthma Other pulmonary diseases; URI within 4 weeks before screening Use of systemic steroids within 1 month before screening or more than 3 times in previous 6 months Beta-adrenergic blocking agent use More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening Pregnant or breast-feeding females Females of child-bearing potential not using adequate means of birth control Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results History of drug or alcohol abuse Treatment with any investigational product within 30 days prior to study entry
Sites / Locations
- Sanofi-Aventis