search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ciclesonide (XRP1526)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Glucocorticosteroid. Bronchospasm

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

Change from baseline to Week 12 in FEV1

Secondary Outcome Measures

Symptom scores, rescue albuterol use and morning peak flow measurements

Full Information

First Posted
September 13, 2005
Last Updated
April 7, 2009
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00174733
Brief Title
Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Glucocorticosteroid. Bronchospasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ciclesonide (XRP1526)
Primary Outcome Measure Information:
Title
Change from baseline to Week 12 in FEV1
Secondary Outcome Measure Information:
Title
Symptom scores, rescue albuterol use and morning peak flow measurements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19549431
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs