Efficacy of Low-Dose Ciclesonide and Fluticasone Propionate for Mild to Moderate Persistent Asthma.

BACKGROUND: The aim of this study was to compare the efficacy of ciclesonide (80 mg/day) and fluticasone propionate (200 mg/day) for mild to moderate persistent asthma. MATERIALS AND METHODS: Female and male patients older than 12 years with a history of persistent bronchial asthma for at least 6 months were enrolled. Patients were eligible to enter into a 2-week run-in period before randomization (baseline) if they had received inhaled corticosteroids (fluticasone propionate 250 μg/day or equivalent) at a constant dose during the last 4 weeks before the run-in period. In order to enter into the double blind 18-week treatment period, patients had to have a forced expiratory volume in 1s (FEV1) of 61-90% of predicted and a decrease in FEV1 throughout the run-in period of more than 10%. Patients (n =230) were assigned to ciclesonide 80 mg once daily or fluticasone propionate 100 mg twice daily group. The primary outcome variable was change in FEV1 compared to its baseline value. Secondary outcome variables were asthma-specific quality of life and asthma control. RESULTS: Both drugs significantly increased FEV1 and other lung function parameters compared to baseline (P< 0.0001, both groups, all variables). Progress in the percentage of days with no asthma symptoms and no use of rescue medication and asthma-specific quality of life were similar in the two treatment groups. CONCLUSION: Ciclesonide at a dose of 80 μg once daily can provide efficient maintenance therapy for mild to moderate persistent asthma.