Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
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
1 other identifier
interventional
286
1 country
11
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2025
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedStudy Start
First participant enrolled
August 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2026
CompletedFebruary 9, 2026
February 1, 2026
5 months
August 1, 2025
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Bronchitis Severity Score(BSS)
Day 4
Study Arms (3)
YHP2401
EXPERIMENTALYHR2402
ACTIVE COMPARATORYHR2403
ACTIVE COMPARATORInterventions
Total 7 days of treatment and The daily dose is tid.(YHP2401 + Placebo of YHR2402 + Placebo of YHR2403)
Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + YHR2402 + Placebo of YHR2403)
Total 7 days of treatment and The daily dose is tid.(Placebo of YHP2401 + Placebo of YHR2402 + YHR2403)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe lung disease as determined by the investigator
- Clinically significant 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 contraindicated concomitant medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2025
First Posted
August 8, 2025
Study Start
August 19, 2025
Primary Completion
January 15, 2026
Study Completion
January 26, 2026
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share