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

Respir Med. 2007 Aug;101(8):1677-86. doi: 10.1016/j.rmed.2007.03.001. Epub 2007 Apr 19.


Objective: To compare the effects of once-daily ciclesonide and twice-daily fluticasone propionate in patients with moderate persistent asthma.

Methods: Patients 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 320 microg once daily (ex-actuator) or fluticasone propionate 200 microg twice daily. Primary efficacy endpoint was change from baseline in FEV1.

Results: In 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).

Conclusions: Treatment 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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Androstadienes / administration & dosage*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Bronchodilator Agents / administration & dosage*
  • Child
  • Drug Administration Schedule
  • Female
  • Fluticasone
  • Forced Expiratory Volume / drug effects
  • Humans
  • Male
  • Middle Aged
  • Pregnenediones / administration & dosage*
  • Respiratory Function Tests


  • Androstadienes
  • Bronchodilator Agents
  • Pregnenediones
  • Fluticasone
  • ciclesonide