Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

Study Overview
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Brief Summary
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The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.

Official Title
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Double-blind, A Multicenter, Randomized, Placebo-controlled, Parallel, Phase 2 Study to Comparative Evaluate the Efficacy of N02RS1 600mg/Day, 12,00mg/Day in Korean Patients With Acute and Chronic Bronchitis

Conditions
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Acute Exacerbation of Chronic Bronchitis

Intervention / Treatment
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* Drug: Combination of Broussonetia spp and Lonicera spp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18, under 75 years of age Patients Acute and Chronic Bronchitis Exclusion Criteria: Patients who have gotten a glucocorticoids treatment within 4 weeks. Patients who need treatments of antibiotic and acute bronchitis infection. Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days. Bronchial asthma patient. Patients who have an indication of bleeding. Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response. Patients who have history of over 3 phage of Chronic obstructiv lung disease Bronchiectasis patients.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N02RS1 200mg<br>Combination of Broussonetia spp and Lonicera spp | Drug: Combination of Broussonetia spp and Lonicera spp<br>* 600 mg/ day or 1200 mg/ day for 7 days<br>* Other names: N02RS1;|
| Experimental: N02RS1 400mg<br>Combination of Broussonetia spp and Lonicera spp | Drug: Combination of Broussonetia spp and Lonicera spp<br>* 600 mg/ day or 1200 mg/ day for 7 days<br>* Other names: N02RS1;|
| Placebo Comparator: Placebo<br>Sugar pill | Drug: Combination of Broussonetia spp and Lonicera spp<br>* 600 mg/ day or 1200 mg/ day for 7 days<br>* Other names: N02RS1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | 1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product. | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Before and after physical examination Before and after bital Sign: blood pressure, pulse rate, temperature. Before and after Lanza Score at the duodenum and stomach Lab: hematologic examination, blood coagulation examination,urine examination Cumulative incidence rate of an endoscopic peptic ulcer. | 12weeks |