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.

First Received: September 13, 2005 Last Updated: April 7, 2009 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00174733

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Asthma

Drug Information available for: Ciclesonide Corticosteroids

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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

Keywords provided by Sanofi-Aventis:

Glucocorticosteroid. Bronchospasm

Study placed in the following topic categories:

Bronchial Spasm
Bronchial Diseases
Ciclesonide
Asthma
Anti-Allergic Agents
Naphazoline
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Guaifenesin
Lung Diseases
Hypersensitivity, Immediate
Phenylpropanolamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Bronchial Diseases
Immune System Diseases
Ciclesonide
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 02, 2009