Status:
COMPLETED
Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule
Lead Sponsor:
Kwang-Ha Yoo
Collaborating Sponsors:
Hanlim Pharm. Co., Ltd.
Conditions:
Acute Bronchitis
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
Brief Summary
The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
Detailed Description
The purpose of this clinical trial is to evaluate the following in patients with acute bronchitis at the 7th day of administration of the investigational drug. primary purpose: Prove the non-inferior...
Eligibility Criteria
Inclusion
- Adult aged 19 to 80 at the time of screening
- Patients with an acute bronchitis severity score (BSS) of 5 or higher at the time of screening and the first day of administration of the investigational drug
- Patients with symptoms of acute bronchitis within 48 hours from the time of screening
- Patients who voluntarily gave written consent to participate in this clinical trial
Exclusion
- Patients with a known hypersensitivity reaction to the components of this investigational product
- Patients with respiratory and systemic infections requiring systemic antibiotic treatment
- Patients with clotting disorders or bleeding tendencies
- Patients with peptic ulcer at the time of screening
- Severe lung diseases that may affect the efficacy evaluation of this clinical trial at the discretion of the investigator
- For screening test results, creatinine clearance \< 25 mL/min or AST, ALT more than 3 times the upper limit of normal
- A person who have administered systemic corticosteroids or immunosuppressants within 4 weeks of the first administration of the investigational drug
- A person who have administered antiviral drugs, systemic/inhaled glucocorticosteroids within 48 hours of the first administration of investigational drugs
- A person who have administered mucolytics, sputum discharge agents, antitussives, herbal medicines with antitussive/ expectorant effects, and antihistamines within 48 hours of the first administration of investigational drugs
- A person who need or plan to take contraindicated drugs or therapies during this clinical trial period
- Patient with liver cirrhosis or cystathionine synthetase deficiency
- Patient who have clinically significant diseases and disorders in the cardiovascular system, endocrine system, and central nervous system at the time of screening, or who have a history of malignant tumors or mental disorders (eg. depression) (However, participation is possible if there is no recurrence for more than 5 years after surgery at the time of screening)
- A person with a history of alcoholism or drug abuse
- Heavy smokers (more than 15 cigarettes per day) within 4 weeks from the time of screening
- Pregnant or lactating
- Among female subjects of childbearing potential, women who do not intend to use appropriate contraceptive methods or plan to become pregnant during this clinical trial
- A person who administered other investigational drugs within 4 weeks from the time of screening
- A person who are not suitable for participation in this clinical trial under the judgment of the investigator
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06038084
Start Date
April 15 2022
End Date
May 16 2023
Last Update
September 14 2023
Active Locations (1)
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1
Konkuk University Hospital
Seoul, South Korea, 05030