Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)

Study Overview
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Brief Summary
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A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)

Detailed Description
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Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis

Official Title
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Double-blind, Randomized, Placebo Controlled, Multicenter, Phase IV Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet (Streptokinase • Streptodornase) in Patients With Acute Upper Respiratory Infection or Acute Bronchitis

Conditions
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Acute Upper Respiratory Infection, Acute Bronchitis

Intervention / Treatment
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* Drug: MUCOLASE tablet (streptokinase • streptodornase)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19≤ age Patients with acute upper respiratory infection or acute bronchitis Patients with cough and phlegm within 48 hrs as of Visit 1 Patients understood the consents and purpose of this trial and signed consent form Exclusion Criteria: Patients with high fever (≥39℃) Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc. Patients with a history of hypersensitivity to drug Patients with abnormal blood coagulation Patients with thrombocytopenia Patients with uncontrolled hypertension Patients with a severe liver disorder(AST or ALT level exceeds 2 times more than normal upper range) Patients woth a clinically significant renal failure(MDRD eGFP < 60 mL/min/1.73m2)

Ages Eligible for Study
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Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mucolase<br> | Drug: MUCOLASE tablet (streptokinase • streptodornase)<br>* streptokinase • streptodornase 5mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo of MUCOLASE tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BSS (Bronchitis Severity Score) | BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe) | baseline, 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in each symptom score of BSS (Bronchitis Severity Score) | BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe) | baseline, 7 days | 
| Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score) | BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe) | baseline, 7 days | 
| Complete resolution rate of each symptom |  | 7 days | 
| The number of use of relief drugs |  | 7 days | 
| Integrative Medicine Outcomes Scale | Integrative Medicine Outcomes Scale is assessed separately by th subjects and thd investigators at end of study, based on BSS of baseline. (Scoring system: 1 = complete recovery, 2 = major improvement, 3 = slight-to-moderate improvement, 4 = no change, 5 =deterioration) | 7 days | 
| Integrative Medicine Patient Satisfaction Scales | Integrative Medicine Outcomes Scale is assessed by subgects at end of study. (Scoring system: 1 = very satisfied, 2 = satisfied, 3 = neutral, 4 = dissatisfied, 5 =very dissatisfied) | 7 days |