A4/207 – Ciclesonide 160μg once daily is as effective as budesonide 400μg once daily in improving the quality of life in children with persistent asthma and their caregivers

Abstract

The efficacy and systemic effects of ciclesonide, a novel glucocorticosteroid, inhaled via pressurized metered-dose inhaler (pMDI) were compared with fluticasone propionate pMDI in 26 patients with asthma, using a randomized, double blind, placebo-controlled, double dummy, 6-period crossover study design. Treatments were placebo, ciclesonide 320 μg (ex-actuator dose) once daily (o.d.), ciclesonide 640 μg o.d., ciclesonide 640 μg twice daily (b.i.d.), fluticasone propionate 440 μg (ex-actuator dose) b.i.d., and fluticasone propionate 880 μg b.i.d. The primary variable was area under the plasma cortisol concentration–time curve over 24 h (plasma cortisol AUC0–24, relative to placebo) derived from samples taken every 2 h, on the 9th day of treatment. Secondary variables were 24-h urinary cortisol excretion and PC20 for adenosine 5′-monophosphate (AMP) (relative to placebo and expressed in doubling concentrations). Ciclesonide did not affect 24-h cortisol secretion. Fluticasone propionate suppressed cortisol secretion as demonstrated by a decrease in plasma cortisol AUC0–24, relative to placebo, by 29% (95% CI 15–41) and 59% (95% CI 51–66) with 440 and 880 μg b.i.d., respectively. PC20 more than doubled with each active treatment, but no statistically significant dose–response effect could be established. It was concluded that moderate to high doses of fluticasone propionate suppressed cortisol secretion, that ciclesonide did not suppress cortisol secretion, and that all active treatments decreased hyperresponsiveness to AMP.