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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Ciclesonide (XRP1526)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00174720

EFC6164

XRP1526B/3031

Details and patient eligibility

About

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.

Enrollment

708 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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