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

NCT ID: NCT00174720

Last Updated: 2009-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 708 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-02-28

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Ciclesonide (XRP1526)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Sanofi-Aventis Administrative Office

Santiago, , Chile

Sanofi-Aventis Administrative Office

San José, , Costa Rica

Sanofi-Aventis Administrative Office

Tallinn, , Estonia

Sanofi-Aventis Administrative Office

Netanya, , Israel

Sanofi-Aventis Administrative Office

Riga, , Latvia

Sanofi-Aventis Administrative Office

México, , Mexico

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Sanofi-Aventis Administrative Office

San Juan, , Puerto Rico

Sanofi-Aventis Administrative Office

Moscow, , Russia

Countries

United States; Brazil; Chile; Costa Rica; Estonia; Israel; Latvia; Mexico; Poland; Puerto Rico; Russia

References

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.

Reference Type: DERIVED

PMID: 19549432 (View on PubMed)

Other Identifiers

XRP1526B/3031

Identifier Type: -

Identifier Source: secondary_id

EFC6164

Identifier Type: -

Identifier Source: org_study_id