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

Summary 

Objective

To compare the efficacy of ciclesonide (80 μg/day) with fluticasone propionate (200 μg/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 μg/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 μg (ex-actuator) once daily in the evening or fluticasone propionate 100 μg (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 μg once daily and fluticasone propionate 100 μg twice daily in mild to moderate persistent asthma. The low dose of ciclesonide was efficacious during long-term treatment.

EudraCT number: 2004-001072-39.

Keywords: Asthma control, Ciclesonide, Efficacy, Fluticasone propionate, Long-term treatment, Low-dose inhaled corticosteroid