Allergol Int. 2013 Mar;62(1):37-43.

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 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.

Department of Pediatrics, Jikei Daisan Hospital, Tokyo, Japan. tkatsunuma@jikei.ac.jp

 

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.

PMID: 23000726

Fig. 4Fig. 1. Changes in % peak expiratory flow (PEF) in the morning. % PEF improved significantly in the tulobuterol group within 1 week of starting treatment, and continued to increase thereafter.

Fig. 5Fig. 2. Changes in fractional exhaled nitric oxide (FeNO). there were no marked changes in FeNO during the study in either group.

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