- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174746
Dose Response Study of Inhaled Ciclesonide (Glucocorticosteroid) to Patients With Persistent Asthma
April 7, 2009 updated by: Sanofi
A Placebo- and Active-Controlled (Ciclesonide Metered-Dose Inhaler), Randomized, Parallel-Group, Dose-Range Finding Study of Ciclesonide Administered by Dry Powder Inhaler (Ultrahaler) in Adult and Adolescent Patients With Persistent Asthma
To investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a metered dose inhaler
Study Overview
Study Type
Interventional
Enrollment (Actual)
1145
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 for at least 1 month before screening; At screening, FEV1 40% or more of predicted normal and at randomization, FEV1 between 40 and 80% predicted normal; 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Primary endpoint will be the change from baseline to week 6 in FEV1
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Secondary Outcome Measures
Outcome Measure |
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PK parameters measured after 4 weeks of treatment. Change from baseline in serum cortisol pre-and post ACTH stimulation, AM and PM peak expiratory flow rates, AM and PM asthma symptoms, and albuterol use after 6 weeks of treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
April 8, 2009
Last Update Submitted That Met QC Criteria
April 7, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DFI6153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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