Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis

Study Overview
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Brief Summary
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Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis

Conditions
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Acute Bronchitis

Intervention / Treatment
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* Drug: Acebrophylline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 19 to 65 years, inclusive Patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for Bronchitis severity score (BSS) at Screening Patients who agreed to participate clinical trial and sign on informed consent form Exclusion Criteria: Patients who are suspicious or diagnosed for pneumonia Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma Patients with active infection who needs administration of antibiotics Patients with myocardial infarction, congestive heart failure Patients with renal disorder or liver disorder Patients with hypotension or hypertension Patients with history of epilepsy Patients with hyperthyroidism Patients with gastroduodenal ulcer Patients with sever hypoxemia Patients who are in drug or therapy or planned to have; antibiotics, anti-virus, angiotensin converting enzyme (ACE) inhibitor and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial Angiotension II receptor blocker (ARB), secretolytics/mucolytics, expectorants, antitussives, a herb medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symtomatic therapy for other therapy for acute bronchitis: whole period for clinical trial Smokers Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug Patients with pregnant and/or have breast feeding. Patients with no intention to use appropriate contraceptives or has a plan to become pregnant Patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial Patients who are identified as inappropriate by other investigators to participate clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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: Sulfolase CR (200mg, QD)<br>for 7 days with or without meal | Drug: Acebrophylline<br> <br> |
| Active Comparator: Sulfolase Capsule (100mg, BID)<br>for 7 days with or without meal | Drug: Acebrophylline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS) |  | Baseline, At Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in baseline to Day 7 for number of BSS per symptom |  | Baseline, At Day 7 | 
| Response rate at Day 7 |  | Baseline, At Day 7 |