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.
| Original language | English |
|---|---|
| Pages (from-to) | 37-43 |
| Number of pages | 7 |
| Journal | Allergology International |
| Volume | 62 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2013 |
| Externally published | Yes |
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Keywords
- Asthma
- Child
- Preschool
- Theophylline
- Transdermal patch
- Tulobuterol
ASJC Scopus subject areas
- Immunology and Allergy
Cite this
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, Toshio; Fujisawa, Takao; Nagao, Mizuho; Akasawa, Akira; Nomura, Ichiro; Yamaoka, Akiko; Kondo, Hisashi; Masuda, Kei; Yamaguchi, Koichi; Terada, Akihiko; Ikeda, Masanori; Nishioka, Kenji; Adachi, Yuichi; Kurihara, Kazuyuki.
In: Allergology International, Vol. 62, No. 1, 2013, p. 37-43.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Effects of transdermal tulobuterol in pediatric asthma patients on long-term leukotriene receptor antagonist therapy
T2 - Results of a randomized, open-label, multicenter clinical trial in japanese children aged 4-12 years
AU - Katsunuma, Toshio
AU - Fujisawa, Takao
AU - Nagao, Mizuho
AU - Akasawa, Akira
AU - Nomura, Ichiro
AU - Yamaoka, Akiko
AU - Kondo, Hisashi
AU - Masuda, Kei
AU - Yamaguchi, Koichi
AU - Terada, Akihiko
AU - Ikeda, Masanori
AU - Nishioka, Kenji
AU - Adachi, Yuichi
AU - Kurihara, Kazuyuki
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
KW - Asthma
KW - Child
KW - Preschool
KW - Theophylline
KW - Transdermal patch
KW - Tulobuterol
UR - http://www.scopus.com/inward/record.url?scp=84875156886&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84875156886&partnerID=8YFLogxK
U2 - 10.2332/allergolint.12-OA-0437
DO - 10.2332/allergolint.12-OA-0437
M3 - Article
C2 - 23000726
AN - SCOPUS:84875156886
VL - 62
SP - 37
EP - 43
JO - Allergology International
JF - Allergology International
SN - 1323-8930
IS - 1
ER -