Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma

¹ Dept of Respiratory Medicine, Ghent University Hospital, Belgium
² Dept of Respiratory Diseases, Université de Liège, Belgium
³ Nycomed Pharma, Konstanz, Germany
⁴ Dept of Endocrinology, Ghent University Hospital, Belgium

^* To whom correspondence should be addressed. E-mail: eric.derom{at}Ugent.be.

	Abstract

We compared the systemic and clinical effects of ciclesonide (CIC) and fluticasone propionate (FP), given on top of CIC 160 µg·day^-1 and salmeterol 50 µg twice daily in 32 patients with persistent asthma using a randomized double-blind, placebo-controlled, double-dummy, five-period crossover design.

All patients exhibited a PC₂₀ methacholine <8 mg·ml^-1 and a PC₂₀ adenosine <60 mg·ml^-1. Primary outcome was 24-h serum cortisol suppression after seven days. Secondary outcomes were changes in PC₂₀ methacholine and adenosine after 9 days.

FP 500 µg·day^-1 and 1000 µg·day^-1 significantly suppressed cortisol secretion versus placebo by –46.2 (95%C.I.: –83.8, –8.5) nmol·L^-1 and by –76.1 (95%C.I.: –112.9, –39.3) nmol·L^-1, respectively. Neither dose of CIC (320 or 640 µg·day^-1) had a significant suppressive effect [–28.2 (95%C.I.: –65.5, +9.2) nmol·L^-1 and – 37.3 (95%C.I.: –74.7, 0.0) nmol·L^-1, respectively]; differences between FP 1000 µg·day^-1 and both CIC treatments were statistically significant [for CIC 320 µg·day^-1: –48.0 (95%C.I.: –84.8, –11.1) nmol·L^-1; for CIC 640 µg·day^-1: –38.8 (95%C.I.: –75.7, –1.9) nmol·L^-1]. Compared with placebo, the increase in PC₂₀ adenosine after the four treatments was small, but significant. Greater improvements in PC₂₀ adenosine were seen with FP 500 µg·day^-1 [1.8 (95%C.I.: 1.0, 2.6) doubling concentrations] compared with CIC 320 µg·day^-1 [0.9 (95%C.I.: 0.1, 1.7) doubling concentrations]; no significant difference was seen between CIC 640 µg·day^-1 and FP 1000 µg·day^-1.

For a similar decrease in hyperresponsiveness, cortisol secretion was suppressed significantly with moderate to high doses of FP, but not with CIC.