Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma.
BACKGROUND
Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning.


OBJECTIVE
This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the efficacy and safety of ciclesonide with fluticasone propionate in children with mainly moderate and severe persistent asthma.


METHODS
Seven hundred and forty-four patients (aged 6-11 years) were randomized to ciclesonide (80 or 160 microg once daily) or fluticasone propionate (88 microg twice daily), following a 2-4-week run-in. Efficacy measurements included forced expiratory flow in 1s (FEV(1)), morning peak expiratory flow (PEF), asthma symptom scores, rescue medication use and quality of life. Systemic effect was assessed by 24-hour urine free cortisol adjusted for creatinine.


RESULTS
FEV(1) and morning PEF increased from baseline in all groups (p<0.0001). Ciclesonide 160 microg was not inferior to fluticasone propionate 176 microg for FEV(1) (p=0.0030, one-sided). In all groups, asthma symptom score sums and rescue medication use significantly improved (p<0.0001). The percentages of asthma symptom-, rescue medication- and nocturnal awakening-free days were high, with no significant differences between treatments. Quality of life scores improved with all treatments (p<0.0001). A significant dose-response occurred between low and higher doses of ciclesonide for exacerbations and asthma control definitions. The incidences of adverse events were comparable across treatments. Urine free cortisol levels decreased significantly with fluticasone propionate (p=0.0103), but not with ciclesonide.


CONCLUSIONS
Once-daily ciclesonide has a clinical effect similar to that of fluticasone propionate, but does not suppress cortisol excretion, in children with moderate and severe asthma.
Pedersen
Søren
S
Research Unit, Department of Paediatrics, Kolding Hospital, DK-6000, Kolding, Denmark. spconsult@post1.tele.dk
Engelstätter
Renate
R
Weber
Hans-Jochen
HJ
Hirsch
Sabine
S
Barkai
László
L
Emeryk
Andrej
A
Weber
Heinrich
H
Vermeulen
Jan
J
D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000523:psychology; D016085:Bronchoconstrictor Agents; D002648:Child; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D008168:Lung / Q000503:physiopathology; D008297:Male; D016210:Methacholine Chloride; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D016085:Bronchoconstrictor Agents; D011282:Pregnenediones; D016210:Methacholine Chloride; D000068298:Fluticasone; C120481:ciclesonide; D006854:Hydrocortisone