Korean J Intern Med.  2020 Jan;35(1):133-141. 10.3904/kjim.2018.181.

HL301 in the treatment of acute bronchitis: a phase 2b, randomized, double-blind, placebocontrolled, multicenter study

Affiliations
  • 1Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea
  • 2Department of Pulmonology and Critical Care Medicine, Kyung Hee University School of Medicine, Seoul, Korea
  • 3Department of Internal Medicine, College of Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea
  • 4Department of Pulmonary and Critical Care Medicine, Ajou University School of Medicine, Suwon, Korea
  • 5Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
  • 6Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
  • 7Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea

Abstract

Background/Aims
There is insufficient 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.

Keyword

HL301; Acute bronchitis; Bronchitis severity score; Herb
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