Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent Asthma
Completed · Phase 2
Conditions studied: Asthma
In brief
To investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a metered dose inhaler
Key facts
- Study ID
- NCT00174746
- Run by
- Sanofi
- People needed
- 1145
- Starts
- 2005-03-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2009-04-08
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females 12 years or older; History of persistent bronchial asthma for at least 6 months; Documented use of an inhaled steroid for at least 1 month before screening; At screening, FEV1 40% or more of predicted normal and at randomization, FEV1 between 40 and 80% predicted normal; Reversibility of FEV1 by at least 12% and 200 ml post-bronchodilator; Be able to use oral inhalers; Non-smokers
You may not qualify if…
- 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
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
Full record on ClinicalTrials.gov
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