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 1 s (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 320 μg once daily (ex-actuator) or fluticasone propionate 200 μg 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 −31 mL (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<0.0001). Improvement in health-related quality of life (HRQoL) from baseline was significantly greater with ciclesonide than fluticasone (p=0.005; one-sided). There were no cases of oral candidiasis in patients receiving ciclesonide and nine cases (3.8%) in those receiving fluticasone propionate (p=0.002; one-sided).ConclusionsTreatment with once-daily ciclesonide and twice-daily fluticasone propionate resulted in similar improvements in lung function in patients with moderate persistent asthma. Ciclesonide showed significant improvements in oral candidiasis and HRQoL over fluticasone.