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

NCT ID: NCT00174733

Last Updated: 2009-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-02-28

Brief 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.

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 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

• 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

Bridgewater, New Jersey, United States

Countries

United States

References

Meltzer EO, Korenblat PE, Weinstein SF, Noonan M, Karafilidis J. Efficacy and safety evaluation of ciclesonide in mild-to-moderate persistent asthma previously treated with inhaled corticosteroids. Allergy Asthma Proc. 2009 May-Jun;30(3):293-303. doi: 10.2500/aap.2009.30.3241.

Reference Type: DERIVED

PMID: 19549431 (View on PubMed)

Other Identifiers

XRP1526B/3030

Identifier Type: -

Identifier Source: secondary_id

EFC6163

Identifier Type: -

Identifier Source: org_study_id