Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid

Sanofi

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Ciclesonide (XRP1526)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00174733

XRP1526B/3030

EFC6163

Details and patient eligibility

About

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.

Enrollment

456 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 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