Acute BronchitisPhase 3AG2001 P3NCT07198347
Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
A Phase 3 study testing AG2001, AG20011 and AG20012 in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- AG2001, AG20011 and AG20012
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 31 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- AG2001, AG20011, AG20012
- Keywords
- acute bronchitis, Cough, Sputum
- Medical subject headings
- Bronchitis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG2001Drug
Oral administration, three times daily for 7 days.
AG20011Drug
Oral administration, three times daily for 7 days.
AG20012Drug
Oral administration, three times daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| AG2001 | Experimental | Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days. Receives: Drug: AG2001 |
| AG20011 | Active comparator | Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days. Receives: Drug: AG20011 |
| AG20012 | Active comparator | Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days. Receives: Drug: AG20012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bronchitis Severity Score (BSS) from Baseline to Day 4
The difference in BSS total score compared between treatment and comparator groups.
Measured: Baseline to Day 4
Secondary outcomes (6)
Change in Bronchitis Severity Score (BSS) from Baseline to Day 7
Evaluation of the change in BSS total score between baseline and Day 7.
Measured: Baseline to Day 7
Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7
Assessment of individual BSS subscale scores including cough and sputum severity.
Measured: Baseline to Day 4 and Day 7
Proportion of BSS Responders at Day 4 and Day 7
Percentage of participants achieving predefined responder criteria based on BSS score improvement.
Measured: Baseline to Day 4 and Day 7
Change in Integrative Medicine Outcome Scale (IMOS)
Evaluation of IMOS scores as secondary endpoints.
Measured: Baseline to Day 4 and Day 7
Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)
Evaluation of IMPSS scores as secondary endpoints.
Measured: Baseline to Day 4 and Day 7
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety evaluation including the number and proportion of participants experiencing AEs and SAEs.
Measured: Up to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198347
- Sponsor's protocol ID
- AG2001 P3
- Other IDs
- AG2001 P3
- Acronym
- AG2001 P3
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07198347
- Acronym / sponsor ID
- AG2001 P3 / AG2001 P3
- Conditions
- Acute Bronchitis
- Keywords
- acute bronchitis, Cough, Sputum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AG2001 | Experimental | Drug: AG2001Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days. |
| AG20011 | Active comparator | Drug: AG20011Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days. |
| AG20012 | Active comparator | Drug: AG20012Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG2001Oral administration, three times daily for 7 days. | Drug | AG2001 |
| AG20011Oral administration, three times daily for 7 days. | Drug | AG20011 |
| AG20012Oral administration, three times daily for 7 days. | Drug | AG20012 |
Primary outcome
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.
6 secondary outcomes
Change in Bronchitis Severity Score (BSS) from Baseline to Day 7
Time frame: Baseline to Day 7
Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7
Time frame: Baseline to Day 4 and Day 7
Proportion of BSS Responders at Day 4 and Day 7
Time frame: Baseline to Day 4 and Day 7
Change in Integrative Medicine Outcome Scale (IMOS)
Time frame: Baseline to Day 4 and Day 7
Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)
Time frame: Baseline to Day 4 and Day 7
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 30 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AG2001, AG20011 and AG20012 in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjoung Choi (+821029610629, agrndct@ahn-gook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bronchitis Severity Score (BSS) from Baseline to Day 4 (time frame: Baseline to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.