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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered for Twelve Weeks Either in a Once-Daily Regimen in the Morning (160 μg qd AM) or in a Twice Daily Regimen (80 μg Bid) in Adults and Adolescents With Mild to Moderate Persistent Asthma Treated Previously With Inhaled Corticosteroids

Conditions
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Asthma

Intervention / Treatment
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* Drug: Ciclesonide (XRP1526)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ciclesonide (XRP1526)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 12 in FEV1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores, rescue albuterol use and morning peak flow measurements |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucocorticosteroid. Bronchospasm