title: Optimal step-down approach for pediatric asthma controlled by salmeterol/fluticasone: A randomized, controlled trial (OSCAR study).
abstract: BACKGROUND
  Several guidelines, including the Japanese Pediatric Guideline for the Treatment and Management of Asthma (JPGL), recommend salmeterol/fluticasone combination therapy (SFC) as step 3 to 4 treatment for moderate to severe asthma. However, the optimal step-down approach to SFC remains unclear. In the current study, we examined step-down approaches in asthmatic children whose symptoms had been stabilized by SFC 100/200 μg/day.
  
  
  METHODS
  This randomized, multicenter, open-label, parallel-group study was conducted over 12 weeks. For step-down therapy, subjects aged 5-15 years were randomly assigned to an SFC group (25/50 μg b.i.d.) or an FP group (100 μg b.i.d.), and treated for 12 weeks. Childhood Asthma Control Test (C-ACT) scores, lung function, and exhaled nitric oxide (FeNO) levels were monitored.
  
  
  RESULTS
  Of 131 enrolled subjects, 128 completed the study and were included in the analysis. Decreases in % peak expiratory flow rate and % forced expiratory flow at 50% of vital capacity (V50) were observed in the FP group at each time point. There was a significant difference between the two groups for the change in %V50 from its previous value at each time point. There were no significant changes in FeNO levels (range 15-20 ppb) or C-ACT scores (∼26 points) within or between groups.
  
  
  CONCLUSIONS
  A high level of asthma control was maintained with both approaches. The use of SFC step-down resulted in somewhat better respiratory function, with no worsening of airway inflammation. However, halving the dose of SFC and switching to FP alone are both optimal step-down approaches.
authors.affiliation: Department of Pediatrics, Jikei University Daisan Hospital, Tokyo, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Akashi
authors.affiliation: Division of Molecular Epidemiology, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Mezawa
authors.affiliation: Iwamizawa Pediatric and Gynecology Clinic, Hokkaido, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Tabata
authors.affiliation: Atsuta Pediatric Clinic, Mie, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Atsuta
authors.affiliation: Tokuda Family Clinic, Mie, Japan.
authors.forename: Reiko
authors.initials: R
authors.lastname: Tokuda
authors.affiliation: Kawada Children and Allergy Clinic, Shizuoka, Japan.
authors.forename: Yasusuke
authors.initials: Y
authors.lastname: Kawada
authors.affiliation: Department of Pediatrics, Nippon Kokan Fukuyama Hospital, Hiroshima, Japan.
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Kitamura
authors.affiliation: Tenshodo Clinic, Tokyo, Japan.
authors.forename: Hiroko
authors.initials: H
authors.lastname: Murasugi
authors.affiliation: Sotobo Children's Clinic, Chiba, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ito
authors.affiliation: Donguri-Kodomo-Clinic, Saitama, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Tabata
authors.affiliation: Shirao Clinic of Pediatrics & Pediatric Allergy, Hiroshima, Japan; Department of Pediatrics, National Hospital Organization Hiroshima-Nishi Medical Center, Hiroshima, Japan.
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Shirao
authors.affiliation: Department of Pediatrics, Tokyo Medical University, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Sato
authors.affiliation: Department of Pediatrics, Tone Central Hospital, Gunma, Japan.
authors.forename: Hideko
authors.initials: H
authors.lastname: Nishimura
authors.affiliation: Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Fujiwara
authors.affiliation: Department of Pediatrics, The Fraternity Memorial Hospital, Tokyo, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Masuda
authors.affiliation: Department of Pediatrics, Gunma University Graduate School of Medicine, Gunma, Japan.
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Arakawa
authors.affiliation: Department of Pediatrics, University of Toyama, Toyama, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Adachi
authors.affiliation: Department of Pediatrics, Dokkyo Medical University, Tochigi, Japan.
authors.forename: Shigemi
authors.initials: S
authors.lastname: Yoshihara
authors.affiliation: Allergy Center, Mie National Hospital, Mie, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Fujisawa
authors.affiliation: Department of Pediatrics, Jikei University Daisan Hospital, Tokyo, Japan. Electronic address: tkatsunuma@jikei.ac.jp.
authors.forename: Toshio
authors.initials: T
authors.lastname: Katsunuma
mesh_terms: D000293:Adolescent; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004338:Drug Combinations; D045853:Exhalation; D005260:Female; D000068298:Fluticasone / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D009569:Nitric Oxide; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D009569:Nitric Oxide; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone
keywords: Fluticasone propionate; Moderate to severe asthma; Pediatric asthma; Salmeterol/fluticasone combination therapy; Step-down approach