A Phase 3 interventional study of DW5121 and DW51211 in Acute Bronchitis, sponsored by Daewon Pharmaceutical Co., Ltd.. Completed at 8 sites in South Korea. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
Acute bronchitis is a common respiratory condition characterized by inflammation of the bronchial tubes, leading to symptoms such as coughing, sputum production, and discomfort. Effective treatment options with improved symptom control and safety profiles are needed.
This Phase 3, randomized, double-blind, parallel-group, multi-center, active-controlled, superiority trial aims to evaluate the efficacy and safety of DW5121 compared to DW51211 and DW51212 in patients with acute bronchitis. Eligible participants were randomized in a 1:1:1 ratio to receive either DW5121, DW51211, or DW51212 for 7 days.
The primary objective is to assess the change in total Bronchitis Severity Score (BSS) at Day 4 (±1 day) after drug administration, and to demonstrate the superiority of DW5121 compared to both comparators.
The secondary objectives include:
Participants visited the study site at baseline, Day 4 (Visit 3), and Day 7 (Visit 4). A follow-up safety check (Visit 5) was conducted approximately 5 days after the last visit. Additional site visits or assessments were performed as necessary based on investigator's discretion to monitor adverse events.
This study provides important data on the potential benefits of DW5121 in managing symptoms of acute bronchitis, with an emphasis on both clinical efficacy and patient safety.
156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.
This study's enrollment of 273 is above the median of 185 across 105 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 48 studies on the registry; 7 are open to participants now.
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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.
Subjects must meet all of the following criteria to be eligible for the study:
Exclusion Criteria:
Subjects who meet any of the following conditions will not be eligible to participate in this clinical trial:
1. History of to any component of the product or to drugs of a similar class.
2. Presence of any of the following medical histories or past surgical/interventional histories:
Renal impairment ( \< 30 mL/min)
*eGFR (mL/min/1.73m²) = 175 × (serum creatinine)\^(-1.154) × (age)\^(-0.203) × 0.742 (if female)
(1) Disease-free for at least 5 years following completion of cancer treatment
(2) Subjects who have completed curative resection of basal cell carcinoma or squamous cell carcinoma of the skin, curative surgery for papillary thyroid carcinoma, or successful treatment of cervical carcinoma in situ at least 3 years prior to screening
3. Subjects expected to require any of the following medications during the clinical trial:
4. Heavy smokers (≥15 cigarettes/day)
For e-cigarettes, 10 puffs are considered equivalent to one conventional cigarette.
5. Pregnant or lactating women, or women who are unwilling to use appropriate * or who are planning to become pregnant during the study period.
Acceptable contraceptive methods include hormonal contraception, intrauterine devices, sterilization of the partner (vasectomy or tubal ligation), or double-barrier methods (e.g., male condom with female diaphragm, sponge, or cervical cap).
6. Participation in another clinical trial and administration of an investigational drug or device within 4 weeks prior to screening
7. Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in this clinical trial
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
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).
Time frame: Day 4 after first dose
Change from baseline in Bronchitis Severity Score (BSS) total score at Day 7 after dosing
Change from baseline in total BSS score at Day 7 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).
Time frame: Day 7 after first dose
Change from baseline in Bronchitis Severity Score (BSS) symptom scores at Days 4 and 7 after dosing
Changes from baseline in individual BSS symptom scores at Days 4 and 7 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).
Time frame: Days 4 and 7 after first dose
Response rate at Days 4 and 7 after dosing
Response defined as total BSS score ≤3 or a decrease of ≥7 points from baseline at Days 4 and 7 after dosing.
Time frame: 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
Overall improvement will be assessed separately by the investigator and the patient at Days 4 and 7 after dosing using a protocol-defined 5-point categorical scale. The scale consists of the following categories: 4 (cure), 3 (significant improvement), 2 (improvement), 1 (some improvement), 0 (non-improvement or worsening of symptoms). Higher scores indicate better improvement.
Time frame: Days 4 and 7 after first dose
Treatment efficacy rate based on improvement at Days 4 and 7 after dosing
Treatment efficacy defined as "cure" or "significant improvement" based on investigator and patient assessment of overall improvement at Days 4 and 7 after dosing.
Time frame: Days 4 and 7 after first dose
Patient satisfaction with treatment using a 5-point scale at Days 4 and 7 after dosing
Patient satisfaction with treatment will be assessed by the patient at Days 4 and 7 after dosing using a protocol-defined 5-point categorical scale. The scale consists of the following categories: 4 (very satisfied), 3 (satisfied), 2 (neutral), 1 (dissatisfied), 0 (very dissatisfied). Higher scores indicate better improvement.
Time frame: Days 4 and 7 after first dose
Comparison of Bronchitis Severity Score (BSS) total score changes at Days 4 and 7 after dosing(DW51211 vs DW51212)
Comparison of change from baseline in total BSS score at Days 4 and 7 after administration of 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).
Time frame: Days 4 and 7 after first dose
Plan to share: No
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