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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174733
First received: September 13, 2005
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Ciclesonide (XRP1526)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline to Week 12 in FEV1

Secondary Outcome Measures:
  • Symptom scores, rescue albuterol use and morning peak flow measurements

Enrollment: 456
Study Start Date: July 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174733

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174733     History of Changes
Other Study ID Numbers: EFC6163, XRP1526B/3030
Study First Received: September 13, 2005
Last Updated: April 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Glucocorticosteroid. Bronchospasm

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014