Status:
COMPLETED
Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid
Lead Sponsor:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT00174733
Start Date
July 1 2005
End Date
February 1 2006
Last Update
April 8 2009
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807