NCT00174733CompletedPhase 3
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
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 456
- Locations
- 2
- Primary Endpoint
- Change from baseline to Week 12 in FEV1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change from baseline to Week 12 in FEV1
Secondary Outcomes
- Symptom scores, rescue albuterol use and morning peak flow measurements
Investigators
Study Sites (2)
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