title: Effect of ciclesonide on allergen challenge in subjects with bronchial asthma.
abstract: BACKGROUND
  The aim of this clinical trial was to investigate whether repeated inhalation of the new inhaled steroid ciclesonide reduces the early-phase (EAR) and late-phase (LAR) reactions after allergen challenge in patients with mild allergic asthma. Also, this study provides further data on safety and tolerance of ciclesonide.
  
  
  METHODS
  The study was designed as a double-blind placebo-controlled randomized crossover trial. Following a baseline period, patients were randomized to either of two treatment sequences (ciclesonide/placebo, placebo/ciclesonide) each of which lasted for one week and were separated by 3-5 weeks from the alternate treatment sequence. Patients received 800 micro g ciclesonide twice daily by means of a Cyclohaler. At the end of each treatment patients were subjected to an allergen challenge.
  
  
  RESULTS
  Thirteen asthmatic patients (mean FEV1 of 91% predicted) who experienced an EAR and LAR after allergen challenge participated in the study. The time-average FEV1 decreases 0-2 h (2-12 h) after allergen challenge as measure of the EAR (LAR) were significantly reduced (P < 0.05, one-sided) from 0.426 L to 0.233 L (EAR) and from 0.443 L to 0.213 L (LAR), respectively. Thus, the study results suggest that ciclesonide significantly lowered the extent of EAR and LAR compared to placebo. Ciclesonide was well tolerated and no drug-related adverse events were reported. Cortisol excretion in 24-h urine showed no significant difference between ciclesonide and placebo.
  
  
  CONCLUSIONS
  The study supports the efficacy and safety of ciclesonide.
authors.affiliation: University Hospital Aarhus, Aarhus, Denmark.
authors.forename: B B
authors.initials: BB
authors.lastname: Larsen
authors.forename: L P
authors.initials: LP
authors.lastname: Nielsen
authors.forename: R
authors.initials: R
authors.lastname: Engelstätter
authors.forename: V
authors.initials: V
authors.lastname: Steinijans
authors.forename: R
authors.initials: R
authors.lastname: Dahl
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001985:Bronchial Provocation Tests; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000494:pharmacology* / Q000627:therapeutic use; D012129:Respiratory Function Tests; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D011282:Pregnenediones; C120481:ciclesonide