Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
NCT ID: NCT07198347
Last Updated: 2025-09-30
Study Results
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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NOT_YET_RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-11-01
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AG2001
Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days.
AG2001
Oral administration, three times daily for 7 days.
AG20011
Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days.
AG20011
Oral administration, three times daily for 7 days.
AG20012
Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days.
AG20012
Oral administration, three times daily for 7 days.
Interventions
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AG2001
Oral administration, three times daily for 7 days.
AG20011
Oral administration, three times daily for 7 days.
AG20012
Oral administration, three times daily for 7 days.
Eligibility Criteria
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Inclusion Criteria
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
* 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
19 Years
64 Years
ALL
No
Sponsors
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Ahn-Gook Pharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Central Contacts
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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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