KMID : 0390020090190020125
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Pediatric Allergy and Respiratory Disease 2009 Volume.19 No. 2 p.125 ~ p.136
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An open, Multi center, Randomized, Parallel Group Study to Compare the Effectiveness and Safety of Fluticasone Plus Tulobuterol Versus Twice the Dose of Fluticasone Alone in Asthmatic Children
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Jeon You-Hoon
Yang Hyeon-Jong Yoo Young Kim Young-Ho Choung Ji-Tae Lee Hae-Ran Pyun Bok-Yang
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Abstract
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Purpose : We aim to compare the effectiveness and safety of fluticasone propionate (Flt) plus tulobuterol (Hk) versus high-dose Flt alone in controlling asthma in children.
Methods : Fifty three children aged 4 to 8 years, who were diagnosed with mild persistent asthma and underwent maintenance therapy with a low dose of inhaled corticosteroid (Flt) of 50-100 ¥ìg/day were randomized to receive Flt plus Hk (Hokunalin¢ç patch 1 mg, Abbott Japan, Tokyo, Japan), or Flt alone at twice the dosage. Patients underwent new treatment for 4 weeks. Asthma symptom scores, mean changes in morning and evening peak expiratory flow (PEF), the frequency of night awakenings, the use of reliever medication, caregiver¡¯s overall satisfaction and safety were evaluated and compared in each group. And they were followed-up again 4 week after treatment course for the evaluation of treatment-emergent adverse event (TEAE).
Results : No significant difference was found between the groups in terms of mean changes in the morning and evening PEF, the frequency of night awakening, the use of rescue medication and caregiver¡¯s overall satisfaction (P=0.83, P=0.83, P=0.17, P=0.32 and P=0.63). Furthermore, no statistically significant difference was observed between 2 groups in the incidence of any TEAE (P=1.00).
Conclusion : This study demonstrated that a combination of Flt and Hk was as effective as a high-dose Flt therapy in the management of mild persistent asthma in children. The results of this study suggest that tulobuterol add-on therapy can be considered as a reasonable substitute to an increase in the dosage of steroid in the patients with steroid-phobia and it might be used to reduce the risk of high dose steroid therapy.
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KEYWORD
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Asthma, Fluticasone propionate, Tulobuterol
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