Abstract
A multi-center, open-label study was conducted to evaluate the efficacy and safety of ciclesonide (administered via a metered-dose inhaler, referred to as BTR-15) 50μg, 100μg or 200μg administered once daily for 28 weeks in 69 children with asthma (5-15 years of age) . The data of all of the 69 patients were included for both the efficacy and safety analyses.
No specific adverse events associated with long-term administration of ciclesonide occurred. No safety concerns arose over the long-term 28-week administration period for the BTR-15 dose range examined in this study, that is, 50μg to 200μg daily. Adequate improvement of the PEF levels was observed in the patients administered BTR-15 50μg, 100μg or 200μg once daily, based on the asthmatic symptoms. The efficacy of BTR-15 was maintained throughout the 28-week administration period.
