Back to resultsComparative Evaluate the Efficacy to Acute and Chronic Bronchitis
Primary Purpose
Acute Exacerbation of Chronic Bronchitis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Combination of Broussonetia spp and Lonicera spp
Sponsored by
About this trial
This is an interventional treatment trial for Acute Exacerbation of Chronic Bronchitis
Eligibility Criteria
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.
Sites / Locations
- Seoul Nat'l University of Boramae Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
N02RS1 200mg
N02RS1 400mg
Placebo
Arm Description
Combination of Broussonetia spp and Lonicera spp
Combination of Broussonetia spp and Lonicera spp
Sugar pill
Outcomes
Primary Outcome Measures
Safety
1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01979926
Brief Title
Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaKing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N02RS1 200mg
Arm Type
Experimental
Arm Description
Combination of Broussonetia spp and Lonicera spp
Arm Title
N02RS1 400mg
Arm Type
Experimental
Arm Description
Combination of Broussonetia spp and Lonicera spp
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar pill
Intervention Type
Drug
Intervention Name(s)
Combination of Broussonetia spp and Lonicera spp
Other Intervention Name(s)
N02RS1
Intervention Description
600 mg/ day or 1200 mg/ day for 7 days
Primary Outcome Measure Information:
Title
Safety
Description
1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
Time Frame
12weeks
Secondary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
12weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne B An, Bs
Organizational Affiliation
Korea Pharmaceutical Manufacturers Association
Official's Role
Study Director
Facility Information:
Facility Name
Seoul Nat'l University of Boramae Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis
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