Clinical Trials/NCT06038084

NCT06038084

Completed

Phase 4

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

Kwang-Ha Yoo1 site in 1 country110 target enrollmentApril 15, 2022

ConditionsAcute Bronchitis

InterventionsBronpass Tab.Placebo of Erdos capsule Erdos capsule Placebo of Bronpass Tab.

DrugsBronpass Tab.Placebo of Erdos capsule Erdos capsule Placebo of Bronpass Tab.

Overview

Phase: Phase 4
Intervention: Bronpass Tab.
Conditions: Acute Bronchitis
Sponsor: Kwang-Ha Yoo
Enrollment: 110
Locations: 1
Primary Endpoint: Change in BSS(Bronchitis severity score) total score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2022

End Date

May 16, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kwang-Ha Yoo

Responsible Party

Sponsor Investigator

Principal Investigator

Kwang-Ha Yoo

Professor

Konkuk University Medical Center

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

Arms & Interventions

Bronpass Tab.

Intervention: Bronpass Tab.

Bronpass Tab.

Intervention: Placebo of Erdos capsule

Erdos capsule

Intervention: Erdos capsule

Erdos capsule

Intervention: Placebo of Bronpass Tab.

Outcomes

Primary Outcomes

Change in BSS(Bronchitis severity score) total score

Time Frame: Visit 3 (Day 7)

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 Outcomes

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))
Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline(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))
Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline(Visit 3 (Day 7))
Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)(Visit 3 (Day 7))
Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline(Visit 3 (Day 7))
Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)(Visit 3 (Day 7))