Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With 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 twice daily in patients with mild to moderate asthma, who have not previously been treated with an inhaled corticosteroid.

Official Title
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A Multinational,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 Either in a Once-Daily in the Morning Regimen (160 μg qd AM) for 16 Weeks or in a 160 μg qd AM Regimen for 12 Weeks Preceded by a Twice-Daily Regimen (80 μg Bid) for 4 Weeks,or in an 80 μg Bid Regimen for 16 Weeks,in Adults and Adolescents With Mild to Moderate Persistent Asthma Not Treated With Steroids

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 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

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 16 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