title: Once-daily ciclesonide improves lung function and is well tolerated by patients with mild-to-moderate persistent asthma.
abstract: BACKGROUND
  Inhaled corticosteroids are recommended as first-line therapy for persistent asthma.
  
  
  OBJECTIVE
  We sought to assess the efficacy and safety of ciclesonide once daily in patients with mild-to-moderate persistent asthma.
  
  
  METHODS
  An integrated analysis of 2 identical, multicenter, double-blind, randomized, parallel-group, placebo-controlled trials was conducted. Patients (n = 1015; aged > or =12 years) with mild-to-moderate asthma (FEV1 of 60% to 85% of predicted value) were randomized to ciclesonide 80 microg (CIC80), 160 microg (CIC160), or 320 microg (CIC320), once daily (exactuator doses) in the morning or placebo for 12 weeks.
  
  
  RESULTS
  All ciclesonide groups showed significant improvements from baseline to week 12 in FEV1 compared with the placebo group (CIC80, 0.12 L [P = .0007]; CIC160, 0.13 L [P = .0004]; and CIC320, 0.14 L [P < .0001]). Likewise, FEV1 percent predicted, morning and evening peak expiratory flow, 24-hour asthma symptom score, daily albuterol use, and nighttime awakenings were significantly improved in all ciclesonide groups compared with the placebo group. Overall ciclesonide safety profile and rates of oropharyngeal adverse events for all groups were low and similar to those of the placebo group. Fewer ciclesonide-treated patients exhibited asthma-aggravated adverse events, and fewer ciclesonide-treated patients discontinued the study for any reason or because of a lack of efficacy compared with those in the placebo group. No suppression of hypothalamic-pituitary-adrenal-axis function (as assessed by means of 24-hour urinary cortisol levels corrected for creatinine and peak serum cortisol levels after stimulation with low-dose [1 microg] cosyntropin) was observed with any dose of ciclesonide.
  
  
  CONCLUSIONS
  In this integrated analysis, ciclesonide once daily administered in the morning is effective and well tolerated.
authors.affiliation: Colorado Allergy and Asthma Centers, PC, Denver 80230, USA. dspearlman@coloradoallergy.com
authors.forename: David S
authors.initials: DS
authors.lastname: Pearlman
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Edward
authors.initials: E
authors.lastname: Kerwin
authors.forename: Craig
authors.initials: C
authors.lastname: Laforce
authors.forename: Sudeep
authors.initials: S
authors.lastname: Kundu
authors.forename: Donald
authors.initials: D
authors.lastname: Banerji
mesh_terms: D000328:Adult; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006854:Hydrocortisone / Q000097:blood / Q000652:urine; D008297:Male; D011282:Pregnenediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D011282:Pregnenediones; C120481:ciclesonide; D006854:Hydrocortisone