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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YHP2401 | Experimental |
| |
| YHR2402 | Active Comparator |
| |
| YHR2403 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP2401 | Drug | Total 7 days of treatment and The daily dose is tid.(YHP2401 + Placebo of YHR2402 + Placebo of YHR2403) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bronchitis Severity Score(BSS) | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Hospital Bucheon | Bucheon-si | 14584 | South Korea | |||
| Hallym University Chuncheon Sacred Heart Hospital |
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| 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) |
|
| 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 |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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