Clinical Trial to Evaluate the Efficacy… | Clinical Trial

Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soonchunhyang University Hospital Bucheon, Bucheon-si, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

YHP2401

Drug

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

YHR2402

Drug

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

YHR2403

Drug

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

Primary outcomes

Bronchitis Severity Score(BSS)

Time frame: Day 4

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 8, 2025
Registry last updated: Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed