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NCT Number: NCT07198347

Efficacy and Safety of AG2001 in Patients With Acute Bronchitis

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.

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Cough Infections Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AG2001

Drug

Oral administration, three times daily for 7 days.

AG20011

Drug

Oral administration, three times daily for 7 days.

AG20012

Drug

Oral administration, three times daily for 7 days.

Primary outcomes

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

    Time frame: Baseline to Day 4

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

Secondary outcomes

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

    Time frame: Baseline to Day 7

    Evaluation of the change in BSS total score between baseline and Day 7.

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

    Time frame: Baseline to Day 4 and Day 7

    Assessment of individual BSS subscale scores including cough and sputum severity.

  3. Proportion of BSS Responders at Day 4 and Day 7

    Time frame: Baseline to Day 4 and Day 7

    Percentage of participants achieving predefined responder criteria based on BSS score improvement.

  4. Change in Integrative Medicine Outcome Scale (IMOS)

    Time frame: Baseline to Day 4 and Day 7

    Evaluation of IMOS scores as secondary endpoints.

  5. Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)

    Time frame: Baseline to Day 4 and Day 7

    Evaluation of IMPSS scores as secondary endpoints.

  6. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 30 days after last dose

    Safety evaluation including the number and proportion of participants experiencing AEs and SAEs.

Study contacts

Contact information is provided by the study sponsor or research team.

Minjoung Choi

CONTACT

[email protected]

+821029610629

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study 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

Acronym: AG2001 P3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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