Abstract
A multi-center, randomized, parallel-group, comparative study was conducted to evaluate the efficacy and safety of ciclesonide (administered via a metered-dose inhaler, referred to as BTR-15) vs. Hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) as the reference in children with asthma. A total of 167 children (aged 5-15 years) with asthma were randomized to receive BTR-15 50μg, 100μg or 200μg once daily, or HFA-BDP 50μg twice daily (100μg/day), both for 8 weeks.
A total of 217 patients were enrolled and the data of 167 (69 girls and 98 boys) were analyzed. The median age was 8 years (5-15 years); when rated according to the severity criteria of the Japanese Pediatric Guideline for the Treatment and Management of Bronchial Asthma 2005, 116 had mild persistent, 50 had moderate persistent and 1 had severe persistent asthma.
BTR-15 treatment showed efficacy in all of the dosing groups and no safety problems were found. In the exploratory analysis for the patients stratified by the severity of asthma symptoms, the efficacy and safety of BTR-15 treatment was confirmed in all of the dosing groups in patients with mild and moderate persistent types. The PEF levels and asthmatic symptoms were improved in one patient with severe persistent type who was allocated to the BTR-15 200μg group. There were no adverse events that occurred in this patient.
Based on the above results, BTR-15 is considered to be a clinically useful agent for the treatment of pediatric asthma.
