Allergology International 2013-03-01

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

文献索引：Allergol. Int. 62(1) , 37-43, (2013)

全文：HTML全文

摘要

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.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.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.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.