Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet(Streptokinase • Streptodornase)

Hanmi Pharmaceutical

Status and phase

Unknown

Phase 4

Conditions

Acute Bronchitis

Acute Upper Respiratory Infection

Treatments

Drug: MUCOLASE tablet (streptokinase • streptodornase)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04252963

HM-MUC-401

Details and patient eligibility

About

A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)

Full description

Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis

Enrollment

346 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

19≤ age
Patients with acute upper respiratory infection or acute bronchitis
Patients with cough and phlegm within 48 hrs as of Visit 1
Patients understood the consents and purpose of this trial and signed consent form

Exclusion criteria

Patients with high fever (≥39℃)
Patients with severe respiratory diseases (ex) bronchial asthma, pneumonia, pulmonary tuberculosis, bronchiectasis, mucus sticking, chronic obstructive pulmonary disease (COPD), etc.
Patients with a history of hypersensitivity to drug
Patients with abnormal blood coagulation
Patients with thrombocytopenia
Patients with uncontrolled hypertension
Patients with a severe liver disorder(AST or ALT level exceeds 2 times more than normal upper range)
Patients woth a clinically significant renal failure(MDRD eGFP < 60 mL/min/1.73m2)