Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.
OBJECTIVE
To evaluate the efficacy and safety of three doses of ciclesonide (with or without spacer) in children with persistent asthma.


METHODS
This was a multicentre, double-blind, placebo-controlled, 12-week study of ciclesonide 40, 80 or 160 μg (once daily pm). Children (6-11 years) were randomised 1:1 to treatment via a metered dose inhaler (MDI) or MDI plus spacer. The primary variable was change from baseline in mean morning peak expiratory flow (PEF). Secondary variables included: time to first lack of efficacy (LOE), asthma control, forced expiratory volume in 1 s (FEV(1)), asthma symptom score and quality of life (QoL). Safety assessments included: adverse events (AEs), urinary cortisol excretion and body height.


RESULTS
In total, 1073 children received treatment. At endpoint, mean morning PEF significantly improved with all doses of ciclesonide vs. placebo. There was no difference over placebo in time to first LOE, but ciclesonide was superior to placebo on asthma control, symptom score, FEV(1) and QoL. There were no differences between the spacer or non-spacer subgroups. The incidences of AEs were comparable between treatment groups (approximately 35%) and there were no between-group differences in body height or urinary cortisol.


CONCLUSIONS
Ciclesonide 40-160 μg once daily is effective and well tolerated in children with persistent asthma; its efficacy and safety are unaffected by the use of a spacer. clinicaltrials.gov registration number: NCT00384189.
Pedersen
Søren
S
University of Southern Denmark, Pediatric Research Unit, Kolding Hospital, Kolding, Denmark. sp@spconforsk.dk
Potter
Paul
P
Dachev
Svetoslav
S
Bosheva
Miroslava
M
Kaczmarek
Jadwiga
J
Springer
Ewa
E
Dunkel
Jochen
J
Engelstätter
Renate
R
D000280:Administration, Inhalation; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D001827:Body Height; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use* / Q000652:urine; D008297:Male; D036501:Metered Dose Inhalers; D011282:Pregnenediones / Q000627:therapeutic use*; D012129:Respiratory Function Tests / Q000379:methods*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D011282:Pregnenediones; C120481:ciclesonide; D006854:Hydrocortisone