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Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule

Primary Purpose

Acute Bronchitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bronpass Tab.
Placebo of Erdos capsule
Erdos capsule
Placebo of Bronpass Tab.
Sponsored by
Kwang-Ha Yoo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchitis

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Konkuk University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bronpass Tab.

Erdos capsule

Arm Description

Outcomes

Primary Outcome Measures

Change in BSS(Bronchitis severity score) total score
Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline * The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms.

Secondary Outcome Measures

Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)
Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus) at 7 days after administration of the investigational drug compared to baseline * The BSS score range for each symptom is 0 to 4 with a higher score indicating a greater severity of symptom.
Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)
Overall improvement judged by the investigator on the treatment response at 7 days after administration of the investigational product * The investigator's overall improvement evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater improvement of the subject's symptom.
Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)
Satisfaction of subjects on the treatment response at 7 days after administration of investigational drug * The subject's satisfaction evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater satisfaction.
Number of rescue drug doses
Number of rescue drug doses at 7 days after administration of investigational drug
Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (CRP in mg/L) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.

Full Information

First Posted
July 24, 2023
Last Updated
September 12, 2023
Sponsor
Kwang-Ha Yoo
Collaborators
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06038084
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
December 28, 2022 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kwang-Ha Yoo
Collaborators
Hanlim Pharm. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronpass Tab.
Arm Type
Experimental
Arm Title
Erdos capsule
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bronpass Tab.
Intervention Description
Twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo of Erdos capsule
Intervention Description
Three times a day (It is for the masking.)
Intervention Type
Drug
Intervention Name(s)
Erdos capsule
Intervention Description
Three times a day
Intervention Type
Drug
Intervention Name(s)
Placebo of Bronpass Tab.
Intervention Description
Twice a day (It is for the masking.)
Primary Outcome Measure Information:
Title
Change in BSS(Bronchitis severity score) total score
Description
Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline * The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms.
Time Frame
Visit 3 (Day 7)
Secondary Outcome Measure Information:
Title
Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)
Description
Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus) at 7 days after administration of the investigational drug compared to baseline * The BSS score range for each symptom is 0 to 4 with a higher score indicating a greater severity of symptom.
Time Frame
Visit 3 (Day 7)
Title
Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)
Description
Overall improvement judged by the investigator on the treatment response at 7 days after administration of the investigational product * The investigator's overall improvement evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater improvement of the subject's symptom.
Time Frame
Visit 3 (Day 7)
Title
Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)
Description
Satisfaction of subjects on the treatment response at 7 days after administration of investigational drug * The subject's satisfaction evaluation sheet is a 5-point scale(ranges from 1 to 5) evaluation sheet where a higher score indicates a greater satisfaction.
Time Frame
Visit 3 (Day 7)
Title
Number of rescue drug doses
Description
Number of rescue drug doses at 7 days after administration of investigational drug
Time Frame
Visit 3 (Day 7)
Title
Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline
Description
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (CRP in mg/L) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Time Frame
Visit 3 (Day 7)
Title
Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Description
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Time Frame
Visit 3 (Day 7)
Title
Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Description
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Time Frame
Visit 3 (Day 7)
Title
Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline
Description
Present the descriptive statistics (Mean, standard deviation, median value, minimum value, maximum value) for the change in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of the investigational drug. And compare the difference in the amount of change between the groups on the 7th day compared to the baseline.
Time Frame
Visit 3 (Day 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
Konkuk University Hospital
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of

12. IPD Sharing Statement

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Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule

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