HL301 versus Umckamin in the treatment of acute bronchitis: a phase III, randomized, controlled, double-blind, multicenter study

Won Young Kim, Myung Jae Park, Chin Kook Rhee, Sang Yeub Lee, Do Jin Kim, Dong Gyu Kim, Chang Min Choi, Deog Kyeom Kim, Yee Hyung Kim, Ho Joo Yoon, Jae Yeol Kim

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Abstract

Objective: HL301 is a combination product of seven medicinal plants that has been proven effective in acute bronchitis by two phase II studies. In the present study, its efficacy and safety compared with those of Umckamin in the treatment of acute bronchitis were evaluated in phase III, randomized, controlled, double-blind, multicenter trial design. Methods: A total of 246 acute bronchitis patients were randomized to receive either HL301 (600 mg/day) or Umckamin (333 mg/day) for seven days. The primary outcome was the difference in their baseline (visit 2) and end of treatment (visit 3) bronchitis severity score (BSS). Other efficacy variables included the change in each BSS component (cough, sputum, dyspnea, chest pain, and crackle), response rate, improvement rate, and satisfaction rate with treatment. Results: A full analysis set and per protocol set analysis of both groups revealed that the difference of BSS between visit 2 and visit 3 in the HL301 and Umckamin group was not significantly different (4.58 ± 1.79 versus 4.29 ± 1.88, p =.37 and 4.60 ± 1.81 versus 4.33 ± 1.88, p =.42, respectively). The change in five BSS components (cough, sputum, dyspnea, chest pain, and crackle) of the HL301 and Umckamin groups did not differ after treatment. HL301 or Umckamin treated participants showed an equal level of response, improvement, and satisfaction rates with treatment. Both the HL301 group and Umckamin group showed the same safety profile. Conclusions: HL301 (600 mg/day) was as effective and safe as Umckamin (333 mg/day) in treating acute bronchitis.

Original languageEnglish
JournalCurrent Medical Research and Opinion
DOIs
StateAccepted/In press - 1 Jan 2019

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Keywords

  • acute bronchitis
  • bronchitis severity score
  • HL301
  • Umckamin

Cite this

Kim, W. Y., Park, M. J., Rhee, C. K., Lee, S. Y., Kim, D. J., Kim, D. G., Choi, C. M., Kim, D. K., Kim, Y. H., Yoon, H. J., & Kim, J. Y. (Accepted/In press). HL301 versus Umckamin in the treatment of acute bronchitis: a phase III, randomized, controlled, double-blind, multicenter study. Current Medical Research and Opinion. https://doi.org/10.1080/03007995.2019.1706044