title: Comparison of the effect of low-dose ciclesonide and fixed-dose fluticasone propionate and salmeterol combination on long-term asthma control.
abstract: BACKGROUND
  Patients with mild persistent asthma constitute about 70% of the asthma population; thus, it is important to know which first-line treatment is best for the management of mild asthma. We compared benefits of first-line treatment with ciclesonide and a combination of fluticasone and salmeterol in patients with mild asthma.
  
  
  METHODS
  Patients aged 12 to 75 years with mild persistent asthma were enrolled in a randomized, double-blind, placebo-controlled study. After run-in, patients were randomized to ciclesonide 160 μg once daily (CIC160), fluticasone propionate/salmeterol 100/50 μg bid (FP200/S100), or placebo for 52 weeks. The primary variable was time to first severe asthma exacerbation; the coprimary variable was the percentage of poorly controlled asthma days. Patients recorded asthma symptoms and salbutamol use in electronic diaries and completed a standardized version of the Asthma Quality of Life Questionnaire.
  
  
  RESULTS
  Compared with placebo, the time to first severe asthma exacerbation was prolonged, and lung function was improved with FP200/S100 treatment (P = .0002) but not with CIC160. Both CIC160 and FP200/S100 provided significantly fewer poorly controlled asthma days than placebo (P ≤ .0016 for both active treatments). Moreover, both active treatments provided significantly more asthma symptom-free days (P ≤ .0001), rescue medication-free days (P = .0005, one-sided), and days with asthma control (P ≤ .0033). Overall Asthma Quality of Life Questionnaire scores were significantly higher in both active treatment groups than placebo (P ≤ .0017).
  
  
  CONCLUSIONS
  In mild asthma, FP200/S100 prolonged time to first severe asthma exacerbation, and CIC160 and FP200/S100 were clinically equieffective for most measures of asthma control.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT00163358; URL: www.clinicaltrials.gov.
authors.affiliation: University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Electronic address: d.s.postma@long.umcg.nl.
authors.forename: Dirkje S
authors.initials: DS
authors.lastname: Postma
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Paul M
authors.initials: PM
authors.lastname: O'Byrne
authors.affiliation: University of Odense, Kolping, Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Pedersen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000730:Androstadienes / Q000008:administration & dosage*; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011282:Pregnenediones / Q000008:administration & dosage*; D011788:Quality of Life; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D010919:Placebos; D011282:Pregnenediones; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol; C120481:ciclesonide