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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
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
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