Efficacy and Safety of AG2001 in Patients With Acute Bronchitis

NCT ID: NCT07198347

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AG2001

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

Group Type EXPERIMENTAL

AG2001

Intervention Type DRUG

Oral administration, three times daily for 7 days.

AG20011

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

Group Type ACTIVE_COMPARATOR

AG20011

Intervention Type DRUG

Oral administration, three times daily for 7 days.

AG20012

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

Group Type ACTIVE_COMPARATOR

AG20012

Intervention Type DRUG

Oral administration, three times daily for 7 days.

Interventions

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AG2001

Oral administration, three times daily for 7 days.

Intervention Type DRUG

AG20011

Oral administration, three times daily for 7 days.

Intervention Type DRUG

AG20012

Oral administration, three times daily for 7 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Minjoung Choi

Role: CONTACT

+821029610629

Other Identifiers

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AG2001 P3

Identifier Type: OTHER

Identifier Source: secondary_id

AG2001 P3

Identifier Type: -

Identifier Source: org_study_id

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