Efficacy and Safety of AG2001 in Patients With Acute Bronchitis

NCT07198347 | Not Yet Recruiting Phase 3

• 1 other identifier: AG2001 P3
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Bronchitis

Keywords

acute bronchitis; Cough; Sputum

Outcome Measures

Primary Outcomes (1)

• Change in Bronchitis Severity Score (BSS) from Baseline to Day 4

  The difference in BSS total score compared between treatment and comparator groups.

  Baseline to Day 4

Secondary Outcomes (6)

• Change in Bronchitis Severity Score (BSS) from Baseline to Day 7

  Baseline to Day 7

• Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7

  Baseline to Day 4 and Day 7

• Proportion of BSS Responders at Day 4 and Day 7

  Baseline to Day 4 and Day 7

• Change in Integrative Medicine Outcome Scale (IMOS)

  Baseline to Day 4 and Day 7

• Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)

  Baseline to Day 4 and Day 7

Study Arms (3)

AG2001

EXPERIMENTAL

Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days.

Drug: AG2001

AG20011

ACTIVE COMPARATOR

Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days.

Drug: AG20011

AG20012

ACTIVE COMPARATOR

Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days.

Drug: AG20012

Interventions

AG2001 DRUG

Oral administration, three times daily for 7 days.

AG2001

AG20011 DRUG

Oral administration, three times daily for 7 days.

AG20011

AG20012 DRUG

Oral administration, three times daily for 7 days.

AG20012

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

MeSH Terms

Conditions

Bronchitis; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Minjoung Choi

CONTACT

+821029610629; agrndct@ahn-gook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: November 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share