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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00174720

Enrollment

708

Registered

2005-09-15

Start date

2005-09-30

Completion date

2007-02-28

Last updated

2009-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Glucocorticosteroid. Bronchospasm

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.

Interventions

DRUGCiclesonide (XRP1526)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 16 in FEV1	—

Secondary

Measure	Time frame
Symptom scores, rescue albuterol use and morning peak flow measurements	—

Countries

Brazil, Chile, Costa Rica, Estonia, Israel, Latvia, Mexico, Poland, Puerto Rico, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026