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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174720
• Other study ID #: EFC6164
• Secondary ID: XRP1526B/3031
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 7, 2009
• Start date: September 2005
• Est. completion date: February 2007

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide (XRP1526)

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Chile	Sanofi-Aventis Administrative Office	Santiago
Costa Rica	Sanofi-Aventis Administrative Office	San José
Estonia	Sanofi-Aventis Administrative Office	Tallinn
Israel	Sanofi-Aventis Administrative Office	Natanya
Latvia	Sanofi-Aventis Administrative Office	Riga
Mexico	Sanofi-Aventis Administrative Office	Mexico
Poland	Sanofi-Aventis Administrative Office	Warszawa
Puerto Rico	Sanofi-Aventis Administrative Office	Puerto Rico
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Brazil,  Chile,  Costa Rica,  Estonia,  Israel,  Latvia,  Mexico,  Poland,  Puerto Rico,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Week 16 in FEV1
Secondary	Symptom scores, rescue albuterol use and morning peak flow measurements