Status:
COMPLETED
Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With 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 twice daily in patients with mild to moderate asthma, who have not 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 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT00174720
Start Date
September 1 2005
End Date
February 1 2007
Last Update
April 8 2009
Active Locations (11)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
São Paulo, Brazil
3
Sanofi-Aventis Administrative Office
Santiago, Chile
4
Sanofi-Aventis Administrative Office
San José, Costa Rica