Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174720
First received: September 13, 2005
Last updated: April 7, 2009
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Ciclesonide (XRP1526) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change from baseline to Week 16 in FEV1
Secondary Outcome Measures:
- Symptom scores, rescue albuterol use and morning peak flow measurements
| Enrollment: | 708 |
| Study Start Date: | September 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174720
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174720
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Brazil | |
| Sanofi-Aventis Administrative Office | |
| Sao Paulo, Brazil | |
| Chile | |
| Sanofi-Aventis Administrative Office | |
| Santiago, Chile | |
| Costa Rica | |
| Sanofi-Aventis Administrative Office | |
| San José, Costa Rica | |
| Estonia | |
| Sanofi-Aventis Administrative Office | |
| Tallinn, Estonia | |
| Israel | |
| Sanofi-Aventis Administrative Office | |
| Natanya, Israel | |
| Latvia | |
| Sanofi-Aventis Administrative Office | |
| Riga, Latvia | |
| Mexico | |
| Sanofi-Aventis Administrative Office | |
| Mexico, Mexico | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| Puerto Rico | |
| Sanofi-Aventis Administrative Office | |
| Puerto Rico, Puerto Rico | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00174720 History of Changes |
| Other Study ID Numbers: | EFC6164 XRP1526B/3031 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Glucocorticosteroid. Bronchospasm |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Ciclesonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Allergic Agents |
ClinicalTrials.gov processed this record on September 26, 2016