Efficacy of Ciclesonide Versus Placebo Administered Eithe... | NCT00174733

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

NCT00174733

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 8, 2009Estimated

Enrollment

456Actual

Phase

Phase 3

Conditions

Asthma

Interventions

Ciclesonide (XRP1526)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
XRP1526B/3030

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

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Feb 2006Actual

Completion Date

Feb 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2009

Last Update Posted Date

Apr 8, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

456Actual

Name	Type	Description	Arm Group Labels	Other Names
Ciclesonide (XRP1526)	Drug

Measure	Description	Time Frame
Change from baseline to Week 12 in FEV1

Measure	Description	Time Frame
Symptom scores, rescue albuterol use and morning peak flow measurements

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis		Bridgewater	New Jersey	08807	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19549431	Derived	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.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases