Status:
NOT_YET_RECRUITING
Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Acute Bronchitis
Eligibility:
All Genders
19-64 years
Phase:
PHASE3
Brief Summary
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 demo...
Eligibility Criteria
Inclusion
- 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
- Total Bronchitis Severity Scale ≥ 5
- Total Bronchitis Severity Scale sputum score ≥ 2
- 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
- Chronic respiratory diseases (e.g., COPD, asthma, pneumonia, tuberculosis, lung cancer)
- Clinically significant hepatic, renal, cardiovascular, or neurological disorders
- Use of prohibited medications (e.g., antibiotics, antivirals, corticosteroids) within the washout period
- Positive test for hepatitis B, hepatitis C, or HIV
- Pregnant or breastfeeding women
- Any condition deemed inappropriate by the investigator
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07198347
Start Date
November 1 2025
End Date
October 31 2026
Last Update
September 30 2025
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