ClinicalTrials.gg
CompletedNCT07111468Updated Feb 9, 2026

Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis

A Phase 3 interventional study of YHP2401 and YHR2402 in Acute Bronchitis, sponsored by Yuhan Corporation. Completed at 11 sites in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Yuhan Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
286
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study summary

A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis

02

Conditions studied

  • Acute Bronchitis

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03

In context

Bronchitis

156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.

This study's enrollment of 286 is above the median of 185 across 105 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Yuhan Corporation is the lead sponsor of 110 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female participants 19 years ≤ age ≤ 80 years
  • Patients with acute bronchitis presenting with productive cough symptoms within 48 hours prior to Visit 2 (Baseline)
  • BSS total score ≥ 5 at Visit 2, including Cough score ≥ 2, Sputum score ≥ 1
  • Patients who voluntarily signed the consent form

Exclusion criteria

Exclusion Criteria:

  • Severe lung disease as determined by the investigator
  • abnormal findings or signs on chest X-ray suggesting diagnoses other than acute bronchitis
  • Active infection requiring systemic antibiotic treatment
  • Patients who need to take concomitant medications
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
286 participants (actual)

Study arms

  • Experimental
    YHP2401

    Drug: YHP2401

  • Active comparator
    YHR2402

    Drug: YHR2402

  • Active comparator
    YHR2403

    Drug: YHR2403

Interventions

  • DrugYHP2401

    Total 7 days of treatment and The daily dose is tid.(YHP2401 + Placebo of YHR2402 + Placebo of YHR2403)

  • DrugYHR2402

    Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + YHR2402 + Placebo of YHR2403)

  • DrugYHR2403

    Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + Placebo of YHR2402 + YHR2403)

06

What researchers measure

Primary outcomes

  1. Bronchitis Severity Score(BSS)

    Time frame: Day 4

07

Study locations

11 sites
  • Soonchunhyang University Hospital Bucheon
    Bucheon-si, 14584, South Korea
  • Hallym University Chuncheon Sacred Heart Hospital
    Chuncheon, 24253, South Korea
  • Wonkwang University Hospital
    Iksan, 54538, South Korea
  • Kangbuk Samsung Hospital
    Seoul, 03181, South Korea
  • The Catholic University of Korea, Eunpyeong St.Mary's Hospital
    Seoul, 03312, South Korea
  • Konkuk University Medical Center
    Seoul, 05030, South Korea
  • Kangdong Sacred Heart Hospital
    Seoul, 05355, South Korea
  • SMG-SNU Boramae Medical Center
    Seoul, 07061, South Korea
  • Korea University Guro Hospital
    Seoul, 08308, South Korea
  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
    Uijeongbu-si, 11765, South Korea
  • Ulsan University Hospital
    Ulsan, 44033, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2025 to primary completion in Jan 2026, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2025
First posted
Aug 8, 2025
StartActual
Aug 19, 2025
Primary completionActual
Jan 15, 2026
CompletionActual
Jan 26, 2026
Last update
Feb 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07111468
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Aug 8, 2025
Start date
Aug 19, 2025
Primary completion
Jan 15, 2026
Completion
Jan 26, 2026
Last update
Feb 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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