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

Toshio Katsunuma, Takao Fujisawa, Mizuho Nagao, Akira Akasawa, Ichiro Nomura, Akiko Yamaoka, Hisashi Kondo, Kei Masuda, Koichi Yamaguchi, Akihiko Terada, Masanori Ikeda, Kenji Nishioka, Yuichi Adachi, Kazuyuki Kurihara

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Few studies have examined the efficacy or safety of a transdermal β2 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 β2 agonist is an effective therapy for pediatric asthma without inducing airway inflammation in children on long-term LTRA therapy.

Original languageEnglish
Pages (from-to)37-43
Number of pages7
JournalAllergology International
Volume62
Issue number1
DOIs
Publication statusPublished - 2013
Externally publishedYes

Fingerprint

Leukotriene Antagonists
Multicenter Studies
Asthma
Clinical Trials
Pediatrics
Theophylline
Nitric Oxide
Therapeutics
Drug-Related Side Effects and Adverse Reactions
tulobuterol
Inflammation
Safety

Keywords

  • Asthma
  • Child
  • Preschool
  • Theophylline
  • Transdermal patch
  • Tulobuterol

ASJC Scopus subject areas

  • Immunology and Allergy

Cite this

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. / Katsunuma, Toshio; Fujisawa, Takao; Nagao, Mizuho; Akasawa, Akira; Nomura, Ichiro; Yamaoka, Akiko; Kondo, Hisashi; Masuda, Kei; Yamaguchi, Koichi; Terada, Akihiko; Ikeda, Masanori; Nishioka, Kenji; Adachi, Yuichi; Kurihara, Kazuyuki.

In: Allergology International, Vol. 62, No. 1, 2013, p. 37-43.

Research output: Contribution to journalArticle

Katsunuma, T, Fujisawa, T, Nagao, M, Akasawa, A, Nomura, I, Yamaoka, A, Kondo, H, Masuda, K, Yamaguchi, K, Terada, A, Ikeda, M, Nishioka, K, Adachi, Y & Kurihara, K 2013, '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', Allergology International, vol. 62, no. 1, pp. 37-43. https://doi.org/10.2332/allergolint.12-OA-0437
Katsunuma, Toshio ; Fujisawa, Takao ; Nagao, Mizuho ; Akasawa, Akira ; Nomura, Ichiro ; Yamaoka, Akiko ; Kondo, Hisashi ; Masuda, Kei ; Yamaguchi, Koichi ; Terada, Akihiko ; Ikeda, Masanori ; Nishioka, Kenji ; Adachi, Yuichi ; Kurihara, Kazuyuki. / 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. In: Allergology International. 2013 ; Vol. 62, No. 1. pp. 37-43.
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abstract = "Background: Few studies have examined the efficacy or safety of a transdermal β2 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 β2 agonist is an effective therapy for pediatric asthma without inducing airway inflammation in children on long-term LTRA therapy.",
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AU - Katsunuma, Toshio

AU - Fujisawa, Takao

AU - Nagao, Mizuho

AU - Akasawa, Akira

AU - Nomura, Ichiro

AU - Yamaoka, Akiko

AU - Kondo, Hisashi

AU - Masuda, Kei

AU - Yamaguchi, Koichi

AU - Terada, Akihiko

AU - Ikeda, Masanori

AU - Nishioka, Kenji

AU - Adachi, Yuichi

AU - Kurihara, Kazuyuki

PY - 2013

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N2 - Background: Few studies have examined the efficacy or safety of a transdermal β2 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 β2 agonist is an effective therapy for pediatric asthma without inducing airway inflammation in children on long-term LTRA therapy.

AB - Background: Few studies have examined the efficacy or safety of a transdermal β2 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 β2 agonist is an effective therapy for pediatric asthma without inducing airway inflammation in children on long-term LTRA therapy.

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