A randomized study comparing ciclesonide and fluticasone propionate in patients with moderate persistent asthma

SummaryObjectiveTo compare the effects of once-daily ciclesonide and twice-daily fluticasone propionate in patients with moderate persistent asthma.MethodsPatients aged 12–75 years with moderate bronchial asthma entered a 1–4 week run-in period. For inclusion into the 12-week, randomized, open-label treatment period, patients had to have a forced expiratory volume in 1s (FEV1) of either 60–80% of predicted or ⩾80% of predicted and a defined use of rescue medication and asthma symptoms, depending on previous treatment. Patients received ciclesonide 320μg once daily (ex-actuator) or fluticasone propionate 200μg twice daily. Primary efficacy endpoint was change from baseline in FEV1.ResultsIn total, 474 patients were randomized. FEV1 increased significantly from baseline with ciclesonide and fluticasone propionate in the intention-to-treat (ITT) and per-protocol (PP) analyses (all p<0.0001). Treatment difference was −31mL (95% confidence interval [CI]: −121, 59) in the PP analysis, demonstrating non-inferiority of ciclesonide. Similar findings were seen for other measures of lung function. In the ITT population, asthma symptom scores and rescue medication use decreased with both treatments (all p