Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Asthma	Drug: Ciclesonide (XRP1526)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	708 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	September 2005
Actual Primary Completion Date :	February 2007
Actual Study Completion Date :	February 2007

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from baseline to Week 16 in FEV1

Secondary Outcome Measures :

1. Symptom scores, rescue albuterol use and morning peak flow measurements

Eligibility Criteria

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Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Berger WE, Kerwin E, Bernstein DI, Pedinoff A, Bensch G, Karafilidis J. Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids. Allergy Asthma Proc. 2009 May-Jun;30(3):304-14. doi: 10.2500/aap.2009.30.3242.

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00174720 History of Changes
Other Study ID Numbers:	EFC6164; XRP1526B/3031
First Posted:	September 15, 2005
Last Update Posted:	April 8, 2009
Last Verified:	April 2009

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