@article{4a8b841ecfb941d8b62ce0f7baa014b0,
title = "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",
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.",
keywords = "Asthma, Child, Preschool, Theophylline, Transdermal patch, Tulobuterol",
author = "Toshio Katsunuma and Takao Fujisawa and Mizuho Nagao and Akira Akasawa and Ichiro Nomura and Akiko Yamaoka and Hisashi Kondo and Kei Masuda and Koichi Yamaguchi and Akihiko Terada and Masanori Ikeda and Kenji Nishioka and Yuichi Adachi and Kazuyuki Kurihara",
note = "Funding Information: This study is financially supported by Japan Allergy Foundation. We thank all of the patients and their families, and the investigators at the participating centers for taking part in this study. We particularly thank Takeo Shibata (Shibata Clinic, Mie), Reiko Tokuda (Tokuda Family Clinic, Mie), Yoko Miyabay-ashi (Ono Clinic, Nagano) and Yasunori Ito (Kurobe City Hospital, Toyama) for their help with data collection. We also acknowledge Dr. Nicholas D. Smith for providing editorial support. Funding Information: 1Department of Pediatrics, Jikei Daisan Hospital, 3National Center for Child Health and Development, 7International University of Health and Welfare, Mita Hospital, 8The Fraternity Memorial Hospital, Tokyo, 2National Hospital Organization Mie Hospital, 6Kondo Children{\textquoteright}s Hospital, Mie, 4National Hospital Organization Kanagawa Hospital, 11Nishioka Clinic, 13Kanagawa Children{\textquoteright}s Medical Center, Kanagawa, 5Saitama Medical University, Saitama, 9Daido Hospital, Aichi, 10Department of Pediatrics, Fukuyama Medical Center, Hiroshima and 12Department of Pediatrics, University of Toyama, Toyama, Japan. Authors{\textquoteright} contributions: TK contributed to study design and conception; data collection, analysis and interpretation; writing of the manuscript and approval of the manuscript for submission. TF and MN contributed to study design and conception; data collection, analysis and interpretation; and revising the manuscript. AA and KK contributed to study design and conception; data collection, analysis and interpretation. IN, AY, HK, KM, KY, AT, MI, KN and YA contributed to data collection, analysis and interpretation. Conflict of interest: TF has received honoraria from Ono Pharmaceutical Co., Ltd., fees for promotional materials from Kyorin Pharmaceutical Co., Ltd., and research funding from Pfizer and GlaxoSmithKline. YA has received honoraria from MSD. KK has received honoraria from Ono Pharmaceutical Co., Ltd. and MSD. All other authors have no potential conflicts of interest to declare. Correspondence: Toshio Katsunuma, Department of Pediatrics, Jikei Daisan Hospital, The Jikei University, 4−11−1 Izumi-Honcho, Komae, Tokyo 201−8601, Japan. Email: tkatsunuma@jikei.ac.jp Received 4 March 2012. Accepted for publication 31 May 2012. 2013 Japanese Society of Allergology",
year = "2013",
doi = "10.2332/allergolint.12-OA-0437",
language = "English",
volume = "62",
pages = "37--43",
journal = "Allergology International",
issn = "1323-8930",
publisher = "Japanese Society of Allergology",
number = "1",
}