A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients

Study Overview
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Brief Summary
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A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject

Official Title
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A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab. in Acute Bronchitis Patients

Conditions
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Acute Bronchitis

Intervention / Treatment
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* Drug: HL301(Experimental)
* Drug: Umkamin(Active Comparator)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both gender, 19 years ≤ age ≤ 80 years (Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit) Acute bronchitis within 48hr based on Visit 2 (Randomized Visit) Those who can comply with the requirements of clinical trials Written consent voluntarily to participate in this clinical trial Exclusion Criteria: Patients with respiratory and systemic infections requiring systemic antibiotic therapy Patients with bleeding tendency Patients who investigators determines to severe respiratory disease that would interfere with study assessment Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2 Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HL301(Experimental)<br>Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab] | Drug: HL301(Experimental)<br>* Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]<br>* Other names: HL301 and Placebo of Umkamin;|
| Active Comparator: Umkamin(Active Comparator)<br>Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab] | Drug: Umkamin(Active Comparator)<br>* Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]<br>* Other names: Placebo of HL301 and Umkamin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchitis Severity Total Score(BSS) Change | The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe | Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement and improvement rate of the tester for the treatment | Improvement and improvement rate are assessed by tester according to a 5 factors: Deterioration, No change, Slight to moderate improvement, Major improvement, Complete recovery | Visit 3 (7 day) | 
| The satisfaction of the subject (Questionnaire) | Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied | Visit 3 (7 day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Bronchitis