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| ID | Type | Description | Link |
|---|---|---|---|
| AG2001 P3 | Other Identifier | Ahngook Pharm |
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This is a Phase 3, randomized, double-blind, active-controlled clinical trial designed to evaluate the efficacy and safety of AG2001 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of AG2001 over two active comparators based on the change in Bronchitis Severity Score (BSS) at Day 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG2001 | Experimental | Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days. |
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| AG20011 | Active Comparator | Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days. |
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| AG20012 | Active Comparator | Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG2001 | Drug | Oral administration, three times daily for 7 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bronchitis Severity Score (BSS) from Baseline to Day 4 | The difference in BSS total score compared between treatment and comparator groups. | Baseline to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bronchitis Severity Score (BSS) from Baseline to Day 7 | Evaluation of the change in BSS total score between baseline and Day 7. | Baseline to Day 7 |
| Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7 |
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Inclusion Criteria:
Adults aged ≥19 years to <65 years old
Subjects who present symptoms of Acute Bronchitis with cough and sputum symptoms within 48 hours prior the randomization visit(Visit 2) who satisfy the following
Subjects who without fever(condensed body temperature standard: less than 38.5°C) prior to randomization visit(Visit 2)
Subjects who present symptoms of Acute Bronchitis with cough less then 2 weeks prior to randomization visit(Visit 2)
Written consent voluntarily to participate who can understand the information provided in this clinical trial
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minjoung Choi | Contact | +821029610629 | agrndct@ahn-gook.com |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D003371 | Cough |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| AG20011 |
| Drug |
Oral administration, three times daily for 7 days. |
|
| AG20012 | Drug | Oral administration, three times daily for 7 days. |
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Assessment of individual BSS subscale scores including cough and sputum severity.
| Baseline to Day 4 and Day 7 |
| Proportion of BSS Responders at Day 4 and Day 7 | Percentage of participants achieving predefined responder criteria based on BSS score improvement. | Baseline to Day 4 and Day 7 |
| Change in Integrative Medicine Outcome Scale (IMOS) | Evaluation of IMOS scores as secondary endpoints. | Baseline to Day 4 and Day 7 |
| Change in Integrative Medicine Patient Satisfaction Scale (IMPSS) | Evaluation of IMPSS scores as secondary endpoints. | Baseline to Day 4 and Day 7 |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety evaluation including the number and proportion of participants experiencing AEs and SAEs. | Up to 30 days after last dose |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |