Konkuk University Hospital
Seoul, 05030, South Korea
NCT Number: NCT06038084
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.
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Notify Me19 year–80 year
All sexes
Interventional
Phase 4
Seoul, 05030, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Twice a day
Three times a day (It is for the masking.)
Three times a day
Twice a day (It is for the masking.)
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
Time frame: Visit 3 (Day 7)
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
Time frame: Visit 3 (Day 7)
Overall improvement judged by the investigator on the treatment response at 7 days after administration of the investigational product
Time frame: Visit 3 (Day 7)
Satisfaction of subjects on the treatment response at 7 days after administration of investigational drug
Time frame: Visit 3 (Day 7)
Number of rescue drug doses at 7 days after administration of investigational drug
Time frame: Visit 3 (Day 7)
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)
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)
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)
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.
Kwang-Ha Yoo
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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