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

NCT06038084 | Completed Phase 4

• 1 other identifier: HL-BRPS-501
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Visit 3 (Day 7)

Secondary Outcomes (8)

• Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)

  Visit 3 (Day 7)

• Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)

  Visit 3 (Day 7)

• Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)

  Visit 3 (Day 7)

• Number of rescue drug doses

  Visit 3 (Day 7)

• Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline

  Visit 3 (Day 7)

Study Arms (2)

Bronpass Tab.

EXPERIMENTAL

Drug: Bronpass Tab.; Drug: Placebo of Erdos capsule

Erdos capsule

ACTIVE COMPARATOR

Drug: Erdos capsule; Drug: Placebo of Bronpass Tab.

Interventions

Bronpass Tab. DRUG

Twice a day

Bronpass Tab.

Placebo of Erdos capsule DRUG

Three times a day (It is for the masking.)

Bronpass Tab.

Erdos capsule DRUG

Three times a day

Erdos capsule

Placebo of Bronpass Tab. DRUG

Twice a day (It is for the masking.)

Erdos capsule

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kwang-Ha Yoo: lead
• Hanlim Pharm. Co., Ltd.: collaborator

Study Sites (1)

Konkuk University Hospital

Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: September 14, 2023
• Study Start: April 15, 2022
• Primary Completion: December 28, 2022
• Study Completion: May 16, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

KR (1)