Bridgewater, New Jersey 08807

  • Asthma

Purpose:

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.


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


NCT ID:

NCT00174733


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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