Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
ConditionAcute Bronchitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-64
SponsorAhn-Gook Pharmaceuticals Co.,Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AG2001
- AG20011
- AG20012
Treatment groups
300 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov