Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 mu g/day

Background: The inhaled corticosteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of patients at the recommended dose of 160 mu g/day. However, the relationship between the level of asthma control and increasing doses of Cic is unknown. This study investigated whether long-term treatment with higher doses of Cic would further improve asthma symptoms in patients with uncontrolled asthma despite ICS use. Patients and methods: In a double-blind, randomized, parallel-group study, 367 patients were allocated to one of three treatment arms (Cic 160, 320 and 640 mu g/day). After a single-blind, 3-week baseline period with Cic 160 mu g/day, eligible patients were randomized to receive 52 weeks of treatment with Cic 160, 320 or 640 mu g/day (double-blind period) during which forced expiratory volume in 1 second (FEV1), exacerbations and Asthma Control Questionnaire (ACQ) scores were measured. Results: Treatment with all the three doses was associated with significant improvements in ACQ scores, FEV1 and asthma symptoms (P Conclusion: In patients with persistent, uncontrolled asthma, increasing the Cic dose from 160 to 640 mu g/day provided no clear additional effect. Patients who experience more than one exacerbation per year may benefit from higher doses; however, further studies are necessary to confirm this. All Cic doses were well tolerated