Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

Acute Exacerbation of Chronic Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979926
• Other study ID #: PMK-N02RS1
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2013
• Last updated: May 29, 2014
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Bronchitis
• Bronchitis
• Bronchitis, Chronic

Intervention

Drug:
• Combination of Broussonetia spp and Lonicera spp
600 mg/ day or 1200 mg/ day for 7 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul Nat'l University of Boramae Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.	12weeks	No
Secondary	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	No