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

doi:10.2332/allergolint.12-OA-0437

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

Allergol Int. 2013;62(1):37-43. doi: 10.2332/allergolint.12-OA-0437. Epub 2015 Feb 27.

Authors

Affiliations

¹ Department of Pediatrics, Jikei Daisan Hospital, University of Toyama, Toyama, Japan.. Electronic address: tkatsunuma@jikei.ac.jp.
² National Hospital Organization Mie Hospital, University of Toyama, Toyama, Japan.
³ National Center for Child Health and Development, University of Toyama, Toyama, Japan.
⁴ National Hospital Organization Kanagawa Hospital, University of Toyama, Toyama, Japan.
⁵ Saitama Medical University, Saitama.
⁶ Kondo Children's Hospital, Mie, University of Toyama, Toyama, Japan.
⁷ International University of Health and Welfare, Mita Hospital, University of Toyama, Toyama, Japan.
⁸ The Fraternity Memorial Hospital, Tokyo.
⁹ Daido Hospital, Aichi, University of Toyama, Toyama, Japan.
¹⁰ Department of Pediatrics, Fukuyama Medical center, Hiroshima University of Toyama, Toyama, Japan.
¹¹ Nishioka Clinic, University of Toyama, Toyama, Japan.
¹² Department of Pediatrics, University of Toyama, Toyama, Japan.
¹³ Kanagawa Children's Medical center, Kanagawa, University of Toyama, Toyama, Japan.

PMID: 28942989
DOI: 10.2332/allergolint.12-OA-0437

Abstract

Background: Few studies have examined the efficacy or safety of a transdermal β2 agonist as add-on medicationto 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 (1-2 mg daily) or oral sustained-release theophylline (usual dose, 4-5 mg_kg daily) for 4 weeks. LTRAs were continued throughout the trial. Outcomes included volume 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.

Keywords: asthma; child; preschool; theophylline; transdermal patch; tulobuterol.