A Study to Evaluate the Efficacy and Safety of DW5121 Compared to DW51211 and DW51212

NCT07093697 | Completed Phase 3

• 1 other identifier: DW5121-302
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase 3, randomized, double-blind, active-controlled, parallel-group, multi-center clinical trial to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of DW5121 over DW51211 and DW51212 by comparing the change in total Bronchitis Severity Score (BSS) at Day 4 after administration. Approximately equal numbers of patients were randomized in a 1:1:1 ratio to receive DW5121, DW51211, or DW51212 for 7 days. Efficacy and safety assessments were conducted at Day 4 and Day 7, with a follow-up contact approximately 5 days after the end of treatment to monitor adverse events.

Conditions

Acute Bronchitis

Keywords

Acute bronchitis; Bronchitis Severity Score; respiratory infection; Phase 3 clinical trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Bronchitis Severity Score (BSS) total score at Day 4 after dosing

  The primary efficacy endpoint is the change from baseline in total BSS score at Day 4 after administration of DW5121 compared to DW51211 and DW51212. The BSS is a clinician-rated scale assessing five symptoms of bronchitis (cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea), each scored from 0 (absent) to 4 (very severe), resulting in a total score ranging from 0(no symptoms) to 20(most severe symptoms) where higher scores indicate a worse outcome (more severe bronchitis symptoms).

  Day 4 after first dose

Secondary Outcomes (7)

• Change from baseline in Bronchitis Severity Score (BSS) total score at Day 7 after dosing

  Day 7 after first dose

• Change from baseline in Bronchitis Severity Score (BSS) symptom scores at Days 4 and 7 after dosing

  Days 4 and 7 after first dose

• Response rate at Days 4 and 7 after dosing

  Days 4 and 7 after first dose

• Investigator and patient assessment of overall improvement using a 5-point scale at Days 4 and 7 after dosing

  Days 4 and 7 after first dose

• Treatment efficacy rate based on improvement at Days 4 and 7 after dosing

  Days 4 and 7 after first dose

Study Arms (3)

DW5121 Group

EXPERIMENTAL

Participants receive DW5121, 2 tablets orally, DW51211 Placebo, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days

Drug: DW5121

DW51211 Control Group

ACTIVE COMPARATOR

Participants receive DW5121 placebo, 2 tablets orally, DW51211, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days

Drug: DW51211

DW51212 Control Group

ACTIVE COMPARATOR

Participants receive DW5121 placebo, 2 tablets orally, DW51211 placebo, 2 tablets orally, DW51212 , 1 tablets orally, 3 times a day after meals for 7 days

Drug: DW51212

Interventions

DW5121 DRUG

Participants receive DW5121, 2 tablets orally, DW51211 Placebo, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days

DW5121 Group

DW51211 DRUG

Participants receive DW5121 placebo, 2 tablets orally, DW51211, 2 tablets orally, DW51212 Placebo, 1 tablets orally, 3 times a day after meals for 7 days

DW51211 Control Group

DW51212 DRUG

Participants receive DW5121 placebo, 2 tablets orally, DW51211 placebo, 2 tablets orally, DW51212 , 1 tablets orally, 3 times a day after meals for 7 days

DW51212 Control Group

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be eligible for the study:
• Male or female aged ≥19 years and \<80 years at the time of informed consent.
• Patients diagnosed with acute bronchitis with productive cough symptoms within 48 hours prior to randomization (diagnosis based on clinical symptoms and chest X-ray; additional bacterial or viral testing may be performed if necessary).
• Subjects with a total Bronchitis Severity Score (BSS) of ≥5 and a sputum score of at least 1 at the randomization visit.
• Subjects who voluntarily provided written informed consent to participate in this clinical trial.

You may not qualify if:

• Subjects who meet any of the following conditions will not be eligible to participate in this clinical trial:
• \. History of hypersensitivity to any component of the investigational product or to drugs of a similar class.
• \. Presence of any of the following medical histories or past surgical/interventional histories:
• Active infections requiring systemic antibiotic therapy
• Severe pulmonary diseases as determined by the investigator (e.g., bronchiectasis, bronchogenic carcinoma, interstitial lung disease, pneumonia, active tuberculosis, cystic fibrosis, chronic obstructive pulmonary disease, asthma, chronic bronchitis, emphysema, etc.) or clinically significant abnormal findings on chest X-ray
• Obstructive sleep apnea syndrome
• Glaucoma or elevated intraocular pressure
• Lower urinary tract obstruction (e.g., benign prostatic hyperplasia) or voiding dysfunction
• Hemorrhagic diathesis or bleeding tendency
• Hepatic dysfunction (ALT or AST \> 3 × upper limit of normal)
• Renal impairment (glomerular filtration rate \< 30 mL/min)
• \*eGFR (mL/min/1.73m²) = 175 × (serum creatinine)\^(-1.154) × (age)\^(-0.203) × 0.742 (if female)
• Uncontrolled thyroid dysfunction (TSH ≥ 1.5 × ULN)
• Uncontrolled diabetes mellitus (HbA1c \> 9.0%)
• Uncontrolled hypertension (systolic or diastolic blood pressure ≥ 160/100 mmHg)

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Soonchunhyang University Bucheon Hospital

Bucheon-si, 14584, South Korea

Location

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, 24253, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Wonkwang University Hospital

Iksan, 54538, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital

Seoul, 05355, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Bronchitis; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Jaejeong Shim, Principal Investigator

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 30, 2025
• Study Start: March 28, 2024
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)