Clinical trial NCT00174733: Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid
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
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: 456
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 a twice daily regimen in patients with mild to moderate asthma, who have 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 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

Primary outcomes:
measure: Change from baseline to Week 12 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
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: 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.