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

Jeon, You Hoon; Yang, Hyeon Jong; Yoo, Young; Kim, Young Ho; Jeong, Ji Tae; Lee, Hae Ran; Pyun, Bok Yang

Abstract

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 microgram/day were randomized to receive Flt plus Hk (Hokunalin(R) 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.