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

Double-blind, Randomized, Placebo Controlled, Multicenter, Phase IV Clinical Trial to Assess the Efficacy and Safety of MUCOLASE Tablet (Streptokinase • Streptodornase) in Patients With Acute Upper Respiratory Infection or Acute Bronchitis

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

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

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)