Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy of ciclesonide MDI either as once daily or twice daily in patients with mild to moderate asthma, who have not 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 bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening

• At screening, FEV1 60 to 90% of predicted. Reversibility of FEV1 by at least 12% 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 6 months before screening. Use of inhaled steroids within 30 days before screening. 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