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

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00174733
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-07
• Last Update Posted: 2009-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 12 in FEV1

Secondary Outcome Measures

Name	Time	Method
Symptom scores, rescue albuterol use and morning peak flow measurements

Trial Locations

Locations (1)

Sanofi-Aventis; 🇺🇸 Bridgewater, New Jersey, United States