Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AG2001, AG20011, AG20012.
- Who it may be relevant to
- Registry conditions: Acute Bronchitis. Basic parameters: 19 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
Overview
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.
Interventions
- Drug AG2001
Oral administration, three times daily for 7 days. - Drug AG20011
Oral administration, three times daily for 7 days. - Drug AG20012
Oral administration, three times daily for 7 days.
Primary outcome measures
- Change in Bronchitis Severity Score (BSS) from Baseline to Day 4 [Time frame: Baseline to Day 4]
Secondary outcome measures (6)
- Change in Bronchitis Severity Score (BSS) from Baseline to Day 7 [Time frame: Baseline to Day 7]
- Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7 [Time frame: Baseline to Day 4 and Day 7]
- Proportion of BSS Responders at Day 4 and Day 7 [Time frame: Baseline to Day 4 and Day 7]
- Change in Integrative Medicine Outcome Scale (IMOS) [Time frame: Baseline to Day 4 and Day 7]
- Change in Integrative Medicine Patient Satisfaction Scale (IMPSS) [Time frame: Baseline to Day 4 and Day 7]
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 30 days after last dose]
Eligibility criteria
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
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07198347 · AG2001 P3 · AG2001 P3