상기도 기침 증후군 환자에서 Theobromine의 유효성과 안전성을 평가하기 위한 다기관, 이중맹검, 무작위 배정, 활성대조약 비교 연구

Abstract

Objectives：The objective of this study is to evaluate the efficacy and tolerability of theobromine in patients with upper airway cough syndrome compared to those of levocloperastine. Materials and Method：This was a randomized, double-blind study. One hundred sixty-five patients with upper airway cough syndrome participated in a 5 day treatment; 85 subjects were included in the theobromine treatment group and 80 in the levocloperastine control group. Cough severity score, daytime cough symptom (DCS), nighttime cough symptom (NCS) and cough quality of life questionnaire (CQLQ) were analyzed for symptom analysis, and vital signs and laboratory study were performed for safety evaluation before and after medication administration. Results：The primary efficacy analysis showed that the mean change in cough grade between baseline and follow-up in the treatment group was lower than that in the control group. This led to the conclusion that theobromine has similar efficacy to control treatment. The secondary efficacy analysis of changes in DCS, NCS and CQLQ verified this conclusion. Considering safety, only one case of dyspepsia was considered to be probably related to theobromine. Other tests conducted before and after treatment confirmed the safety of treatment medications. Conclusion：Theobromine is a novel natural antitussive medication that has similar efficacy to levocloperastine and adequate safety.