Efficacy and Safety of AG2001 in Patients With Acute Bronchitis (AG2001 P3)

Ahn-Gook Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Bronchitis

Treatments: Drug: AG20011; Drug: AG2001; Drug: AG20012

Study type: Interventional

Funder types: Industry

Identifiers

NCT07198347

AG2001 P3 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 3 patient groups

AG2001

Experimental group

Description:

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

Treatment:

Drug: AG2001

AG20011

Active Comparator group

Description:

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

Treatment:

Drug: AG20011

AG20012

Active Comparator group

Description:

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

Treatment:

Drug: AG20012