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Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients with acute bronchitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulfolase CR (200mg, QD) | Experimental | for 7 days with or without meal |
|
| Sulfolase Capsule (100mg, BID) | Active Comparator | for 7 days with or without meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acebrophylline | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS) | Baseline, At Day 7 |
| 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 |
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Inclusion Criteria:
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;
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
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C077110 | ambroxol-theophylline-7-acetate |
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| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |