Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy of ciclesonide MDI either as once daily or a twice daily regimen in patients with mild to moderate asthma, who have previously been treated with an inhaled corticosteroid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Ciclesonide

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