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

PharmaKing1 site in 1 country102 target enrollmentNovember 2013

ConditionsAcute Exacerbation of Chronic Bronchitis

InterventionsCombination of Broussonetia spp and Lonicera spp

DrugsCombination of Broussonetia spp and Lonicera spp

Overview

Phase: Phase 2
Intervention: Combination of Broussonetia spp and Lonicera spp
Conditions: Acute Exacerbation of Chronic Bronchitis
Sponsor: PharmaKing
Enrollment: 102
Locations: 1
Primary Endpoint: Safety
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

March 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

PharmaKing

Responsible Party

Sponsor

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.