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.
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.
['Katsunuma|Toshio|T|', 'Fujisawa|Takao|T|', 'Mizuho|Nagao|N|', 'Akira|Akasawa|A|', 'Nomura|Ichiro|I|', 'Yamaoka|Akiko|A|', 'Kondo|Hisashi|H|', 'Masuda|Kei|K|', 'Yamaguchi|Koichi|K|', 'Terada|Akihiko|A|', 'Ikeda|Masanori|M|', 'Nishioka|Kenji|K|', 'Adachi|Yuichi|Y|', 'Kurihara|Kazuyuki|K|']
tulobuterol asthma theophylline child preschool transdermal patch