Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00174720

Run by

Sanofi

People needed

708

Starts

2005-09-01

Expected to finish

2007-02-01

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 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

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — San José, Costa Rica
• Sanofi-Aventis Administrative Office — Tallinn, Estonia
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Riga, Latvia
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — San Juan, Puerto Rico
• Sanofi-Aventis Administrative Office — Moscow, Russia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.