NCT06038084

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Kwang-Ha Yoo · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Bronchitis

Interventions

Type	Name	Description
DRUG	Bronpass Tab.	Twice a day
DRUG	Placebo of Erdos capsule	Three times a day (It is for the masking.)
DRUG	Erdos capsule	Three times a day
DRUG	Placebo of Bronpass Tab.	Twice a day (It is for the masking.)

Timeline

• Start date: 2022-04-15
• Primary completion: 2022-12-28
• Completion: 2023-05-16
• First posted: 2023-09-14
• Last updated: 2023-09-14

Locations

1 site across 1 country: South Korea