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| Name | Class |
|---|---|
| Hanlim Pharm. Co., Ltd. | INDUSTRY |
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The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
The purpose of this clinical trial is to evaluate the following in patients with acute bronchitis at the 7th day of administration of the investigational drug.
primary purpose: Prove the non-inferiority of the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including sputum symptoms, of Bronpass tab. compared to Erdos capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronpass Tab. | Experimental |
| |
| Erdos capsule | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronpass Tab. | Drug | Twice a day |
| |
| Placebo of Erdos capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BSS(Bronchitis severity score) total score | Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline * The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms. | Visit 3 (Day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus) | Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus) at 7 days after administration of the investigational drug compared to baseline * The BSS score range for each symptom is 0 to 4 with a higher score indicating a greater severity of symptom. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Hospital | Seoul | 05030 | South Korea |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| Drug |
Three times a day (It is for the masking.) |
|
| Erdos capsule | Drug | Three times a day |
|
| Placebo of Bronpass Tab. | Drug | Twice a day (It is for the masking.) |
|
| Visit 3 (Day 7) |
| Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale) | Overall improvement judged by the investigator on the treatment response at 7 days after administration of the investigational product * The investigator's overall improvement evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater improvement of the subject's symptom. | Visit 3 (Day 7) |
| Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale) | Satisfaction of subjects on the treatment response at 7 days after administration of investigational drug * The subject's satisfaction evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater satisfaction. | Visit 3 (Day 7) |
| Number of rescue drug doses | Number of rescue drug doses at 7 days after administration of investigational drug | Visit 3 (Day 7) |
| Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline | Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (CRP in mg/L) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline. | Visit 3 (Day 7) |
| Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline | Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline. | Visit 3 (Day 7) |
| Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline | Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline. | Visit 3 (Day 7) |
| Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline | Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline. | Visit 3 (Day 7) |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |