title: Effects of 24-week add-on treatment with ciclesonide and montelukast on small airways inflammation in asthma.
abstract: BACKGROUND
  Eosinophilic inflammation of the small airways is a key process in asthma that often smolders in treated patients. The long-term effects of add-on therapy on the persistent inflammation in the small airways remain unknown.
  
  
  OBJECTIVE
  To examine the effects of add-on therapy with either ciclesonide, an inhaled corticosteroid with extrafine particles, or montelukast on small airway inflammation.
  
  
  METHODS
  Sixty patients with stable asthma receiving inhaled corticosteroid treatment were enrolled in a randomized, open-label, parallel comparison study of 24-week add-on treatment with ciclesonide or montelukast. Patients were randomly assigned to 3 groups: ciclesonide (n = 19), montelukast (n = 22), or no add-on as controls (n = 19). At baseline and at weeks 4, 12, and 24, extended nitric oxide analysis; pulmonary function tests, including impulse oscillometry; blood eosinophil counts; and asthma control tests (ACTs) were performed.
  
  
  RESULTS
  A total of 18 patients in the ciclesonide group, 19 in the montelukast group, and 15 in the control group completed the study and were analyzed. With repeated-measures analysis of variance, ciclesonide produced a significant decrease in alveolar nitric oxide and a significant improvement in ACT scores over time. Montelukast produced significant decreases in alveolar nitric oxide concentrations and blood eosinophil counts over time and slightly improved ACT scores, whereas no such changes were observed in the control group. Alveolar nitric oxide concentrations with ciclesonide and reactance area at low frequencies with montelukast produced greater improvements over time compared with control.
  
  
  CONCLUSIONS
  Ciclesonide add-on therapy and montelukast add-on therapy may act differently, but both separately can improve small airway abnormalities and provide better asthma control.
  
  
  BACKGROUND
  umin.ac.jp/ctr Identifier: UMIN000001083.
authors.affiliation: Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Nakaji
authors.forename: Guergana
authors.initials: G
authors.lastname: Petrova
authors.forename: Hisako
authors.initials: H
authors.lastname: Matsumoto
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Iwata
authors.forename: Isao
authors.initials: I
authors.lastname: Ito
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Oguma
authors.forename: Hideki
authors.initials: H
authors.lastname: Inoue
authors.forename: Tomoko
authors.initials: T
authors.lastname: Tajiri
authors.forename: Tadao
authors.initials: T
authors.lastname: Nagasaki
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kanemitsu
authors.forename: Akio
authors.initials: A
authors.lastname: Niimi
authors.forename: Michiaki
authors.initials: M
authors.lastname: Mishima
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D002452:Cell Count; D002465:Cell Movement / Q000187:drug effects / Q000276:immunology; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D004804:Eosinophils / Q000187:drug effects* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000378:metabolism; D011282:Pregnenediones / Q000008:administration & dosage*; D011650:Pulmonary Alveoli / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology; D011804:Quinolines / Q000008:administration & dosage*; D012129:Respiratory Function Tests; D013440:Sulfides
chemical_list: D000085:Acetates; D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011282:Pregnenediones; D011804:Quinolines; D013440:Sulfides; D009569:Nitric Oxide; C093875:montelukast; C120481:ciclesonide