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Efficacy and Safety of AG2001 in Patients With Acute Bronchitis

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07198347
Acronym
AG2001 P3
Enrollment
300
Registered
2025-09-30
Start date
2025-11-01
Completion date
2026-10-31
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchitis

Keywords

acute bronchitis, Cough, Sputum

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 demonstrate the superiority of AG2001 over two active comparators based on the change in Bronchitis Severity Score (BSS) at Day 4.

Interventions

DRUGAG2001

Oral administration, three times daily for 7 days.

DRUGAG20011

Oral administration, three times daily for 7 days.

DRUGAG20012

Oral administration, three times daily for 7 days.

Sponsors

Ahn-Gook Pharmaceuticals Co.,Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

1. Adults aged ≥19 years to \<65 years old 2. 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 3. Subjects who without fever(condensed body temperature standard: less than 38.5°C) prior to randomization visit(Visit 2) 4. Subjects who present symptoms of Acute Bronchitis with cough less then 2 weeks prior to randomization visit(Visit 2) 5. 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Bronchitis Severity Score (BSS) from Baseline to Day 4Baseline to Day 4The difference in BSS total score compared between treatment and comparator groups.

Secondary

MeasureTime frameDescription
Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7Baseline to Day 4 and Day 7Assessment of individual BSS subscale scores including cough and sputum severity.
Proportion of BSS Responders at Day 4 and Day 7Baseline to Day 4 and Day 7Percentage of participants achieving predefined responder criteria based on BSS score improvement.
Change in Bronchitis Severity Score (BSS) from Baseline to Day 7Baseline to Day 7Evaluation of the change in BSS total score between baseline and Day 7.
Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)Baseline to Day 4 and Day 7Evaluation of IMPSS scores as secondary endpoints.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to 30 days after last doseSafety evaluation including the number and proportion of participants experiencing AEs and SAEs.
Change in Integrative Medicine Outcome Scale (IMOS)Baseline to Day 4 and Day 7Evaluation of IMOS scores as secondary endpoints.

Contacts

Primary ContactMinjoung Choi
agrndct@ahn-gook.com+821029610629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026