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

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

CORRESPONDENCE: E. Derom, Dept of Respiratory Medicine, Ghent University Hospital, De Pintelaan 185, B-9000 Ghent, Belgium. Fax: 32 93322341. E-mail: eric.derom{at}Ugent.be

Keywords: Aerosol therapy, anti-asthmatic agent, asthma, bronchial hyperreactivity, cortisol, inhaled corticosteroids

Received: May 28, 2008
Accepted January 1, 2009

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

All patients exhibited a provocative concentration leading to a 20% decrease in forced expiratory volume in 1 s (PC₂₀) methacholine <8 mg·mL^–1 and a PC₂₀ adenosine <60 mg·mL^–1. Primary outcome was 24-h serum cortisol suppression after 7 days. Secondary outcomes were changes in PC₂₀ methacholine and adenosine after 9 days.

FP 500 µg·day^–1 and 1,000 µg·day^–1 significantly suppressed cortisol secretion versus placebo by -46.2 (95% confidence interval (CI) -83.8– -8.5) nmol·L^–1 and by -76.1 (95% CI -112.9– -39.3) nmol·L^–1, respectively. Neither dose of CIC (320 nor 640 µg·day^–1) had a significant suppressive effect (-28.2 (95% CI -65.5–9.2) nmol·L^–1 and -37.3 (95% CI -74.7–0.0) nmol·L^–1, respectively). Differences between FP 1,000 µg·day^–1 and both CIC treatments were statistically significant (CIC 320 µg·day^–1: -48.0 (95% CI -84.8– -11.1) nmol·L^–1; CIC 640 µg·day^–1: -38.8 (95% CI -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% CI 1.0–2.6) doubling concentrations) compared with CIC 320 µg·day^–1 (0.9 (95% CI 0.1–1.7) doubling concentrations). No significant difference was seen between CIC 640 µg·day^–1 and FP 1,000 µg·day^–1.

For a similar decrease in hyperresponsiveness, cortisol secretion was suppressed significantly with moderate-to-high doses of fluticasone propionate, but not with ciclesonide.