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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014