Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid

Asthma Clinical Trial

Official title:

A 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 for Twelve Weeks Either in a Once-Daily Regimen in the Morning (160 μg qd AM) or in a Twice Daily Regimen (80 μg Bid) in Adults and Adolescents With Mild to Moderate Persistent Asthma Treated Previously With Inhaled Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174733
• Other study ID #: EFC6163
• Secondary ID: XRP1526B/3030
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 7, 2009
• Start date: July 2005
• Est. completion date: February 2006

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 a twice daily regimen in patients with mild to moderate asthma, who have previously been treated with an inhaled corticosteroid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• 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 an inhaled steroid or a combination of an inhaled steroid/long-acting beta 2 agonist for at least 1 month before screening

• At screening, FEV1 of 60 to 90% predicted or 70 to 95% predicted for either ICS or ICS/LABA use respectively.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 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
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Week 12 in FEV1
Secondary	Symptom scores, rescue albuterol use and morning peak flow measurements