title: Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.
abstract: 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.
authors.affiliation: University of Southern Denmark, Pediatric Research Unit, Kolding Hospital, Kolding, Denmark. sp@spconforsk.dk
authors.forename: Søren
authors.initials: S
authors.lastname: Pedersen
authors.forename: Paul
authors.initials: P
authors.lastname: Potter
authors.forename: Svetoslav
authors.initials: S
authors.lastname: Dachev
authors.forename: Miroslava
authors.initials: M
authors.lastname: Bosheva
authors.forename: Jadwiga
authors.initials: J
authors.lastname: Kaczmarek
authors.forename: Ewa
authors.initials: E
authors.lastname: Springer
authors.forename: Jochen
authors.initials: J
authors.lastname: Dunkel
authors.forename: Renate
authors.initials: R
authors.lastname: Engelstätter
mesh_terms: 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
chemical_list: D000893:Anti-Inflammatory Agents; D011282:Pregnenediones; C120481:ciclesonide; D006854:Hydrocortisone