A Phase 3 interventional study of AG2001 and AG20011 in Acute Bronchitis, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Not yet recruiting. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Phase 3, Interventional, and Treatment
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.
156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.
This study's planned enrollment of 300 is above the median of 185 across 105 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days.
Drug: AG2001
Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days.
Drug: AG20011
Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days.
Drug: AG20012
Oral administration, three times daily for 7 days.
Oral administration, three times daily for 7 days.
Oral administration, three times daily for 7 days.
Change in Bronchitis Severity Score (BSS) from Baseline to Day 4
The difference in BSS total score compared between treatment and comparator groups.
Time frame: Baseline to Day 4
Change in Bronchitis Severity Score (BSS) from Baseline to Day 7
Evaluation of the change in BSS total score between baseline and Day 7.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 4 and Day 7
Change in Integrative Medicine Outcome Scale (IMOS)
Evaluation of IMOS scores as secondary endpoints.
Time frame: Baseline to Day 4 and Day 7
Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)
Evaluation of IMPSS scores as secondary endpoints.
Time frame: 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.
Time frame: Up to 30 days after last dose
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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