Clinical trial NCT00174720: Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Glucocorticosteroid. Bronchospasm
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 708
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to Week 16 in FEV1
Secondary outcomes:
measure: Symptom scores, rescue albuterol use and morning peak flow measurements
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: San José
country: Costa Rica
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Natanya
country: Israel
facility: Sanofi-Aventis Administrative Office
city: Riga
country: Latvia
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Puerto Rico
country: Puerto Rico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Berger WE, Kerwin E, Bernstein DI, Pedinoff A, Bensch G, Karafilidis J. Efficacy and safety evaluation of ciclesonide in subjects with mild-to-moderate asthma not currently using inhaled corticosteroids. Allergy Asthma Proc. 2009 May-Jun;30(3):304-14. doi: 10.2500/aap.2009.30.3242.