title: Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma.
abstract: We compared the systemic and clinical effects of ciclesonide (CIC) and fluticasone propionate (FP) administered, in addition to CIC 160 microg x day(-1) and salmeterol 50 microg 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 (PC(20)) methacholine <8 mg x mL(-1) and a PC(20) adenosine <60 mg x mL(-1). Primary outcome was 24-h serum cortisol suppression after 7 days. Secondary outcomes were changes in PC(20) methacholine and adenosine after 9 days. FP 500 microg x day(-1) and 1,000 microg x day(-1) significantly suppressed cortisol secretion versus placebo by -46.2 (95% confidence interval (CI) -83.8- -8.5) nmol x L(-1) and by -76.1 (95% CI -112.9- -39.3) nmol x L(-1), respectively. Neither dose of CIC (320 nor 640 microg x day(-1)) had a significant suppressive effect (-28.2 (95% CI -65.5-9.2) nmol x L(-1) and -37.3 (95% CI -74.7-0.0) nmol x L(-1), respectively). Differences between FP 1,000 microg x day(-1) and both CIC treatments were statistically significant (CIC 320 microg x day(-1): -48.0 (95% CI -84.8- -11.1) nmol x L(-1); CIC 640 microg x day(-1): -38.8 (95% CI -75.7- -1.9) nmol x L(-1)). Compared with placebo, the increase in PC(20) adenosine after the four treatments was small, but significant. Greater improvements in PC(20) adenosine were seen with FP 500 microg x day(-1) (1.8 (95% CI 1.0-2.6) doubling concentrations) compared with CIC 320 microg x day(-1) (0.9 (95% CI 0.1-1.7) doubling concentrations). No significant difference was seen between CIC 640 microg x day(-1) and FP 1,000 microg x 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.
authors.affiliation: Dept of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium. eric.derom@Ugent.be
authors.forename: E
authors.initials: E
authors.lastname: Derom
authors.forename: R
authors.initials: R
authors.lastname: Louis
authors.forename: C
authors.initials: C
authors.lastname: Tiesler
authors.forename: R
authors.initials: R
authors.lastname: Engelstätter
authors.forename: J-M
authors.initials: JM
authors.lastname: Kaufman
authors.forename: G F
authors.initials: GF
authors.lastname: Joos
mesh_terms: D000241:Adenosine; D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D000704:Analysis of Variance; D000730:Androstadienes / Q000008:administration & dosage / Q000627:therapeutic use*; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019540:Area Under Curve; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001985:Bronchial Provocation Tests; D016085:Bronchoconstrictor Agents; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume; D006801:Humans; D006854:Hydrocortisone / Q000378:metabolism*; D016018:Least-Squares Analysis; D008297:Male; D016210:Methacholine Chloride; D008875:Middle Aged; D010919:Placebos; D011282:Pregnenediones / Q000008:administration & dosage / Q000627:therapeutic use*; D000068299:Salmeterol Xinafoate; D013147:Spirometry; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D016085:Bronchoconstrictor Agents; D001993:Bronchodilator Agents; D010919:Placebos; D011282:Pregnenediones; D016210:Methacholine Chloride; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000241:Adenosine; D000420:Albuterol; C120481:ciclesonide; D006854:Hydrocortisone