A 24-week comparison of low-dose ciclesonide and fluticasone propionate in mild to moderate asthma.

Objective: To compare the efficacy of ciclesonide (80 mu g/day) with fluticasone propionate (200 mu g/day) in mild to moderate persistent asthma. Methods: Patients aged 12-75 years and previously treated with low doses of inhaled corticosteroid (fluticasone propionate 250 mu g/day or equivalent) entered a 2-4 week run-in period during which only rescue medication was permitted. For inclusion into the double-blind, 24-week treatment period, patients had to show a forced expiratory volume in 1s (FEV1) of 61-90% predicted and a decrease in FEV1 during run-in of >= 10%. Patients (n = 480) were randomized to ciclesonide 80 mu g (ex-actuator) once daily in the evening or fluticasone propionate 100 mu g (ex-valve) twice daily. The primary efficacy variable was the change from baseline in FEV1. Secondary efficacy variables included asthma control and asthma-specific quality of life. Results: Both treatments significantly increased FEV1 and other lung function variables from baseline (p < 0.0001, both groups, all variables). The least squares mean increases in FEV1 were 0.46L (ciclesonide) and 0.52L (fluticasone propionate); non-inferiority of ciclesonide to fluticasone propionate was demonstrated (p = 0.0002, per-protocol analysis). Five patients in each group experienced asthma exacerbations. Improvements in the percent of days with asthma control (days with no asthma symptoms and no use of rescue medication) and asthma-specific quality of life were comparable between treatments. Conclusions: The study confirmed similar efficacy of ciclesonide 80 mu g once daily and fluticasone propionate 100 mu g twice daily in mild to moderate persistent asthma. The low dose of ciclesonide was efficacious during long-term treatment. EudraCT number: 2004-001072-39. (C) 2010 Published by Elsevier Ltd.