Clinical trial NCT06038084: Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule
Official title: A Prospective, Multi-center, Active-control, Parallel Group, Randomized, Double-blinded, Non-inferiority Investigator Initiative Clinical Trial to Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule on Patients With Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Bronchitis
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
Collaborators: name: Hanlim Pharm. Co., Ltd.
First posted: 2023-09-14
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-inferiority of the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.

secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including sputum symptoms, of Bronpass tab. compared to Erdos capsule.

Eligibility criteria: Inclusion Criteria:

1. Adult aged 19 to 80 at the time of screening
2. 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
3. Patients with symptoms of acute bronchitis within 48 hours from the time of screening
4. Patients who voluntarily gave written consent to participate in this clinical trial

Exclusion Criteria:

1. Patients with a known hypersensitivity reaction to the components of this investigational product
2. Patients with respiratory and systemic infections requiring systemic antibiotic treatment
3. Patients with clotting disorders or bleeding tendencies
4. Patients with peptic ulcer at the time of screening
5. Severe lung diseases that may affect the efficacy evaluation of this clinical trial at the discretion of the investigator
6. For screening test results, creatinine clearance \< 25 mL/min or AST, ALT more than 3 times the upper limit of normal
7. A person who have administered systemic corticosteroids or immunosuppressants within 4 weeks of the first administration of the investigational drug
8. A person who have administered antiviral drugs, systemic/inhaled glucocorticosteroids within 48 hours of the first administration of investigational drugs
9. 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
10. A person who need or plan to take contraindicated drugs or therapies during this clinical trial period
11. Patient with liver cirrhosis or cystathionine synthetase deficiency
12. 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)
13. A person with a history of alcoholism or drug abuse
14. Heavy smokers (more than 15 cigarettes per day) within 4 weeks from the time of screening
15. Pregnant or lactating
16. 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
17. A person who administered other investigational drugs within 4 weeks from the time of screening
18. A person who are not suitable for participation in this clinical trial under the judgment of the investigator

Primary outcomes:
measure: Change in BSS(Bronchitis severity score) total score
timeFrame: Visit 3 (Day 7)
Secondary outcomes:
measure: Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)
timeFrame: Visit 3 (Day 7)
measure: Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)
timeFrame: Visit 3 (Day 7)
measure: Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)
timeFrame: Visit 3 (Day 7)
measure: Number of rescue drug doses
timeFrame: Visit 3 (Day 7)
measure: Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline
timeFrame: Visit 3 (Day 7)
measure: Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline
timeFrame: Visit 3 (Day 7)
measure: Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline
timeFrame: Visit 3 (Day 7)
measure: Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline
timeFrame: Visit 3 (Day 7)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
Study officials:
References: