Hl301 in the treatment of acute bronchitis: A phase 2b, randomized, double-blind, placebo-controlled, multicenter study

Sang Won Yoon, Myung Jae Park, Chin Kook Rhee, Joo Hun Park, Sang Yeub Lee, Do Jin Kim, Dong Gyu Kim, Jae Yeol Kim

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Background/Aims: There is insuff icient quality data to recommend the use of herbs for the treatment of acute bronchitis. Small number of randomized trials of plant extracts for this purpose were determined to be low quality and there are concerns for the safety. HL301 is a combined product of seven medicinal plants. In the present study, we tried to evaluate the efficacy and safety of HL301 for the treatment of acute bronchitis with a randomized, double-blind, placebo-controlled, multicenter trial design. Methods: A total of 166 patients with acute bronchitis were randomized to receive placebo or HL301 (600 mg/day) for 7 days. The primary endpoint was change in bronchitis severity score (BSS) from baseline visit (visit 2) to the end of treatment (visit 3). Other efficacy variables were the change of each component of the BSS (cough, sputum, dyspnea, chest pain, and crackle) with treatment, response rate, improvement rate, satisfaction rate and number of rescue medications taken. Results: Changes in the BSS from visit 2 to visit 3 were higher in the HL301 group than in the placebo group both in the full analysis set (4.57 ± 1.82 vs. 3.15 ± 3.08, p < 0.01) and in the per protocol set (4.62 ± 1.81 vs. 3.30 ± 3.03, p < 0.01). Four BSS components (cough, sputum, dyspnea, and chest pain) improved more with HL301 treatment than with placebo treatment. Participants treated with HL301 showed higher response, improvement, and satisfaction rates and less use of rescue medication than the placebo group. Conclusions: HL301 (600 mg/day) was effective and safe for symptomatic treatment of acute bronchitis.

Original languageEnglish
Pages (from-to)133-141
Number of pages9
JournalKorean Journal of Internal Medicine
Volume35
Issue number1
DOIs
Publication statusPublished - 2020

Keywords

  • Acute bronchitis
  • Bronchitis severity score
  • HL301
  • Herb

ASJC Scopus subject areas

  • Internal Medicine

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