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

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

Official Title
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A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients

Conditions
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Acute Bronchitis

Intervention / Treatment
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* Drug: HL301
* Drug: HL301(Placebo)


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: Experimental<br>HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment | Drug: HL301<br>* HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment<br>|
| Placebo Comparator: Placebo comparator<br>HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment | Drug: HL301(Placebo)<br>* HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchitis Severity Total Score(BSS) Change | Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day) | 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 response (Chi-square test or Fisher's Exact test) | Evaluation period: Visit 3 (7 day) | Visit 3 (7 day) | 
| The satisfaction of the subject (Questionnaire) | Evaluation period: Visit 3 (7 day) | Visit 3 (7 day) | 
| Total usage of Acetaminophen | Evaluation period: Visit 3 (7 day) | 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