title: Effects of transdermal tulobuterol in pediatric asthma patients on  long-term leukotriene receptor  antagonist therapy: results of a  randomized, open-label, multicenter  clinical trial in Japanese children  aged 4-12 years.
abstract: BACKGROUND
  Few studies have examined the efficacy or safety of a transdermal β(2) agonist as add-on medication to long-term leukotriene receptor antagonist (LTRA) therapy in pediatric asthma patients.
  
  
  METHODS
  In this randomized, open-label, multicenter clinical trial, children aged 4-12 years on long-term LTRA therapy were treated with tulobuterol patches (1-2mg daily) or oral sustained-release theophylline (usual dose, 4-5mg/kg daily) for 4 weeks. LTRAs were continued throughout the trial. Outcomes included volume of peak expiratory flow (% PEF), fractional exhaled nitric oxide (FeNO), clinical symptoms and adverse events.
  
  
  RESULTS
  Thirty-three and 31 patients were treated with tulobuterol patches and theophylline, respectively. % PEF measured in the morning and before bedtime was significantly higher at all times in the treatment period compared with baseline in the tulobuterol patch group (p < 0.001), and was significantly higher in the tulobuterol patch group compared with the theophylline group. FeNO was similar and unchanged from baseline in both groups. There were no drug-related adverse events in either group.
  
  
  CONCLUSIONS
  These results suggest that short-term use of a transdermal β(2) agonist is an effective therapy for pediatric asthma without inducing airway inflammation in children on long-term LTRA therapy.
authors.affiliation: Department of Pediatrics, Jikei Daisan Hospital, Tokyo, Japan. tkatsunuma@jikei.ac.jp
authors.forename: Toshio
authors.initials: T
authors.lastname: Katsunuma
authors.forename: Takao
authors.initials: T
authors.lastname: Fujisawa
authors.forename: Mizuho
authors.initials: M
authors.lastname: Nagao
authors.forename: Akira
authors.initials: A
authors.lastname: Akasawa
authors.forename: Ichiro
authors.initials: I
authors.lastname: Nomura
authors.forename: Akiko
authors.initials: A
authors.lastname: Yamaoka
authors.forename: Hisashi
authors.initials: H
authors.lastname: Kondo
authors.forename: Kei
authors.initials: K
authors.lastname: Masuda
authors.forename: Koichi
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Akihiko
authors.initials: A
authors.lastname: Terada
authors.forename: Masanori
authors.initials: M
authors.lastname: Ikeda
authors.forename: Kenji
authors.initials: K
authors.lastname: Nishioka
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Adachi
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Kurihara
mesh_terms: D000279:Administration, Cutaneous; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D020024:Leukotriene Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D012129:Respiratory Function Tests; D013726:Terbutaline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000318:Adrenergic beta-Agonists; D020024:Leukotriene Antagonists; C010809:tulobuterol; D013726:Terbutaline