A Phase 3 interventional study of AG2001 and AG20011 in Acute Bronchitis, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Not yet recruiting. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Phase 3, Interventional, and Treatment
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.
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
Exclusion Criteria:
Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days.
Drug: AG2001
Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days.
Drug: AG20011
Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days.
Drug: AG20012
Oral administration, three times daily for 7 days.
Oral administration, three times daily for 7 days.
Oral administration, three times daily for 7 days.
Change in Bronchitis Severity Score (BSS) from Baseline to Day 4
The difference in BSS total score compared between treatment and comparator groups.
Time frame: Baseline to Day 4
Change in Bronchitis Severity Score (BSS) from Baseline to Day 7
Evaluation of the change in BSS total score between baseline and Day 7.
Time frame: Baseline to Day 7
Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7
Assessment of individual BSS subscale scores including cough and sputum severity.
Time frame: 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.
Time frame: Baseline to Day 4 and Day 7
Change in Integrative Medicine Outcome Scale (IMOS)
Evaluation of IMOS scores as secondary endpoints.
Time frame: Baseline to Day 4 and Day 7
Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)
Evaluation of IMPSS scores as secondary endpoints.
Time frame: 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.
Time frame: Up to 30 days after last dose
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Ahn-Gook Pharmaceuticals Co.,Ltd