title: Efficacy and safety of HL301 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: a phase 2, randomized, double-blind, placebo-controlled, multicenter study.
abstract: OBJECTIVE
  The efficacy and safety of Chinese herbs for symptomatic treatment of bronchitis is not well established. We evaluated the efficacy and safety of a combination product of seven herbs (HL301) for the treatment of acute bronchitis (AB) and acute exacerbation of chronic bronchitis (AECB) using a randomized, double-blind, placebo-controlled, multicenter trial design.
  
  
  METHODS
  A total of 160 patients with AB or with AECB were randomized to receive placebo or one of three doses of HL301 (0.6 g/day, 1.2 g/day, or 1.8 g/day) for a total of 7 days. The primary study endpoint was the change in bronchitis severity score (BSS) from the baseline visit (visit 2) to the end of treatment visit (visit 3). Other efficacy variables were percentage BSS systemic sign efficacy after treatment and change in individual BSS parameters after treatment.
  
  
  RESULTS
  Changes in BSS from visit 2 to visit 3 in the three treatment groups (4.63 ± 2.24, 4.08 ± 1.63, and 4.15 ± 1.74 in the HL301 0.6 g/day, 1.2 g/day, and 1.8 g/day groups, respectively) were higher than that of the placebo group (2.88 ± 2.57) in the per protocol set (PPS) (P < .05), and it was also valid in the full analysis set (FAS). The number of participants whose symptoms (measured by BSS) improved at least 30% after treatment was higher in all three treatment groups compared to the placebo group in both the FAS and the PPS (P < .05, for all).
  
  
  CONCLUSIONS
  Three different doses of HL301 (0.6 g/day, 1.2 g/day, and 1.8 g/day) were effective in decreasing the BSS index compared to placebo. HL301 may be effective for symptomatic treatment of both AB and AECB.
  
  
  CONCLUSIONS
  Essential components of HL301 have not been delineated in the study and patients with AB and AECB were indiscriminately enrolled in the present study. Respective evaluation of the efficacy of HL301 for AB and AECB will be necessary in the future.
authors.affiliation: a Kyung Hee University School of Medicine , Department of Pulmonology and Critical Care Medicine , Seoul , Republic of Korea.
authors.forename: Myung Jae
authors.initials: MJ
authors.lastname: Park
authors.affiliation: b The Catholic University of Korea , Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine , Seoul , Republic of Korea.
authors.forename: Chin Kook
authors.initials: CK
authors.lastname: Rhee
authors.affiliation: c Kyung Hee Univerisity Hospital at Gangdong , Department of Pulmonary and Critical Care Medicine , Seoul , Republic of Korea.
authors.forename: Yee Hyung
authors.initials: YH
authors.lastname: Kim
authors.affiliation: d Soonchunhyang University Bucheon Hospital , Department of Internal Medicine , Bucheon , Republic of Korea.
authors.forename: Do Jin
authors.initials: DJ
authors.lastname: Kim
authors.affiliation: e Hallym University Sacred Heart Hospital , Department of Internal Medicine , Seoul , Republic of Korea.
authors.forename: Dong Gyu
authors.initials: DG
authors.lastname: Kim
authors.affiliation: f College of Medicine, Korea University , Department of Internal Medicine , Seoul , Republic of Korea.
authors.forename: Sang Yeub
authors.initials: SY
authors.lastname: Lee
authors.affiliation: g Chung Ang University Hospital Ringgold Standard Institution , Internal Medicine, Seoul , Republic of Korea.
authors.forename: Jae Yeol
authors.initials: JY
authors.lastname: Kim
mesh_terms: D000208:Acute Disease; D000328:Adult; D001991:Bronchitis / Q000188:drug therapy*; D029481:Bronchitis, Chronic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Acute bronchitis; HL301; acute exacerbation of chronic bronchitis; herbal medicine