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

PharmaKing

Status and phase

Completed

Phase 2

Conditions

Acute Bronchitis

Treatments

Drug: N02RS1 1200mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02637310

PMK-N02RS1_Phase 2B

Details and patient eligibility

About

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

Full description

Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.

Enrollment

108 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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.