NCT00174720|CompletedPhase 3

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

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

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

EFC6164XRP1526B/3031

Study Type

interventional

Target

708

Locations

11 countries

Sites

Timeline

RegisteredSep 2005

StartedSep 2005

CompletionFeb 2007

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

708

participants targeted

Target at P75+ for phase_3 asthma

Timeline

Completed

Started Sep 2005

Geographic Reach

11 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

September 1, 2005

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed

Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

1.4 years

First QC Date

September 13, 2005

Last Update Submit

April 7, 2009

Conditions

Asthma

Keywords

Glucocorticosteroid. Bronchospasm

Outcome Measures

Primary Outcomes (1)

Change from baseline to Week 16 in FEV1

Secondary Outcomes (1)

Symptom scores, rescue albuterol use and morning peak flow measurements

Interventions

Ciclesonide (XRP1526)DRUG

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.