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Trial record 2 of 3 for:    XRP1526B

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

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ClinicalTrials.gov Identifier: NCT00174720
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 8, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date April 8, 2009
Study Start Date  ICMJE September 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Change from baseline to Week 16 in FEV1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Symptom scores, rescue albuterol use and morning peak flow measurements
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: Ciclesonide (XRP1526)
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2008)
708
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
700
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Chile,   Costa Rica,   Estonia,   Israel,   Latvia,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00174720
Other Study ID Numbers  ICMJE EFC6164
XRP1526B/3031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP