Evidence map›Paper›PMID 40859807›Full record

Trial reportThe Korean journal of internal medicine2025

Efficacy and safety of HL-301 compared with erdosteine in acute bronchitis: a randomized, double-blind, non-inferiority trial.

Ji-Yong Moon, Joon Young Choi, Youlim Kim, Hye Jung Park, Yong Bum Park, Seong Yong Lim, Kyung Hoon Min, Deog Kyeom Kim, Chin Kook Rhee, Seung Won Ra and 3 more

Abstract readRandomized Controlled TrialComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Korean journal of internal medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Ji-Yong MoonDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.
Joon Young ChoiDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Youlim KimDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.
Hye Jung ParkDepartment of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Yong Bum ParkDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.
Seong Yong LimDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Kyung Hoon MinDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.
Deog Kyeom KimDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, College of Medicine, Seoul National University, Seoul, Korea.
Chin Kook RheeDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Seung Won RaDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
Chang Youl LeeDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Chuncheon, Korea.
Yong Il HwangDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
Kwang Ha YooDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea.

Funding

Hanlim Pharm Co., Ltd.
6 · The paper itself

Abstract

BACKGROUND/

aimsThis study evaluated the non-inferiority of HL-301 to erdosteine in terms of symptom relief and the anti- inflammatory effects in acute bronchitis patients not treated with antibiotics.

methodsIn a double-blind, non-inferiority trial, patients were randomized 1:1 to receive either HL-301 (300 mg twice daily) or erdosteine (300 mg three times daily) for seven days. The primary endpoint was change in total Bronchitis Severity Score (BSS) from baseline to day 7. The non-inferiority margin was set at -0.99 for the difference in BSS change. The secondary endpoints were changes in specific symptoms, overall improvement, patient satisfaction, and inflammatory markers.

resultsMean BSS reduction at day 7 was -4.43 in the HL-301 group (n = 53) and -4.33 in the erdosteine group (n = 52). The difference in mean BSS change between the groups was 0.11, with the lower limit of the 97.5% one-sided confidence interval at -0.42, confirming non-inferiority. The improvement in specific symptoms, overall improvement, and patient satisfaction were high in both groups; however, there were no significant differences between the groups. Additionally, the changes in C-reactive protein, tumor necrosis factor-alpha, interleukin (IL)-1β, and IL-6 were similar between the groups, with no significant differences observed. The incidence of adverse events was higher in the HL-301 group compared to the erdosteine group, including gastrointestinal disorder, periodontitis, and increased blood cholesterol, although this difference was not statistically significant.

conclusionHL-301 was non-inferior to erdosteine, confirming its positive effect on symptom relief in acute bronchitis patients managed with conservative care.

Indexed as

Anti-Inflammatory AgentsBronchitisExpectorantsThioglycolatesThiophenesAcute DiseaseAdultAgedBiomarkersDouble-Blind MethodFemaleHumansInflammation MediatorsMaleMiddle AgedPatient SatisfactionAnti-Inflammatory AgentsBiomarkerserdosteineExpectorantsInflammation MediatorsThioglycolatesThiophenesBronchitisClinical trialExpectorantsSafety

Identifiers

PMID40859807
PMCPMC12425675

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.