title: Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy.
abstract: BACKGROUND
  Few large-scale studies have examined inhaled corticosteroid treatment in preschool children with recurrent wheeze. We assessed the effects of ciclesonide in preschool children with recurrent wheeze.
  
  
  METHODS
  We included children 2-6 yrs with recurrent wheeze and a positive asthma predictive index or aeroallergen sensitization to, excluding patients with episodic viral wheezing. After a 2-4-week baseline period, patients with ongoing symptoms or rescue medication use were randomised to once-daily ciclesonide 40, 80, 160 μg or placebo for 24 weeks.
  
  
  RESULTS
  The number of wheeze exacerbations requiring systemic corticosteroids was unexpectedly low in all groups: 25 (10.2%) in placebo group, as compared to 11 (4.4%), 18 (7.3%), and 17 (6.7%) in ciclesonide 40, 80, and 160 μg, respectively. The difference in time to first exacerbation was not significantly different between groups (p = 0.786), but the difference in exacerbation rates between placebo and the pooled ciclesonide groups was (p = 0.03). Large and significant (p < 0.0001) improvements in symptom scores and rescue medication use occurred in all groups, including placebo. Improvements in FEV(1) and FEF(25-75) (measured in 284 4-6 yr olds) were larger in the ciclesonide than in the placebo group. No differences in safety parameters (adverse events, height growth, serum and urinary cortisol levels) between ciclesonide and placebo were observed.
  
  
  CONCLUSIONS
  In preschool children with recurrent wheeze and a positive asthma predictive index, ciclesonide modestly reduces wheeze exacerbation rates and improves lung function. A large placebo response and unexpected selection of patients with mild disease may have affected outcomes, highlighting the heterogeneity of preschool wheezing disorders.
authors.affiliation: Princess Amalia Children's Clinic, Isala klinieken, PO Box 10400, 8000 GK Zwolle, The Netherlands. p.l.p.brand@isala.nl
authors.forename: Paul L P
authors.initials: PL
authors.lastname: Brand
authors.forename: María
authors.initials: M
authors.lastname: Luz García-García
authors.forename: Adrian
authors.initials: A
authors.lastname: Morison
authors.forename: Jan H
authors.initials: JH
authors.lastname: Vermeulen
authors.forename: Heinrich C
authors.initials: HC
authors.lastname: Weber
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011282:Pregnenediones / Q000627:therapeutic use*; D012135:Respiratory Sounds / Q000187:drug effects* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D001993:Bronchodilator Agents; D011282:Pregnenediones; C120481:ciclesonide