Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaKing

Criteria

Inclusion Criteria:

• Patients over 19, under 75 of age

• Patients acute bronchitis, sputum symptoms, BSS over 7 points.

• Patients acute bronchitis within 7days.

• Non-pregnant, patients who agree to contraception.

• Patients who can write diary and available to communicate.

• Patients voluntarily agreed

Exclusion Criteria:

• Patients with hypersensitivity to the drug.

• Patients who have gotten systemic steroid treatment within 4 weeks.

• Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.

• Patients who have gotten treatment of mucus solvents or antitussives within 3 days.

• Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.

• Patients heart disease, severe kidney, liver disease.

• The bleeding tendency or immunosuppressed patients.

• Patients with clinically significant abnormal values.

• Pregnant women or nursing mothers.

• Patients alcoholics or drug abuse.

• Patients taking other clinical trail's medicines within 30 days.