A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg (DW224-III-3)

Inclusion Criteria:

• Adult male or female same or older than age of 40
• Severity of acute exacerbation of COPD must suit oral administration treatment
• Diagnosed as COPD before receiving written informed consent and outcome measure of spirometry testing confirmed as FEV1/FVC < 0.7

• Subject showing following signs and symptoms:

  (i)Purulent Sputum or Sputum level is increased; (ii)Difficulty in breathing is increased

• Female subjects who might be pregnant must do pregnancy test and results should be negative before randomization is done. She must receive written informed consent form (NOTE: Subject who has used single hormone contraception for pregnancy control or has not been more than 1 year after Tubul ligation and menopause are excluded from the study)
• Subject who can agree and sign written informed consent form approved by IRB before participating in study and follow study requirements

Exclusion Criteria:

• Subject who administered excess daily dose of antimicrobial/antibiotics in past 72 hours before receiving written consent
• Diagnosed to have pneumonia by taking chest X-ray in past 48 hours before receiving written consent
• Diagnosed to have infectious diseases or such diseases results in complications before receiving written consent (NOTE: Septic shock, Bronchiectasis, Lung abscess, Pneumonia, Active tuberculosis, Pulmonary malignancy, Cystic fibrosis, Empyema, Asthma)

• Have kidney or liver diseases who correspond following criteria:

  (i) CCr < 50 mL/min; (ii) BUN > 30 mg/dl; (iii) ALT 또는 AST > 3 x ULN; (iv) Total bilirubin > 2 x ULN; (v) ALP > 2 x ULN.

• Organic gastrointestinal disorder having abnormal absorption problem condition in past 6 months before receiving written consent (NOTE: Active Crohn's disease, active ulcerative colitis)
• Diagnosed to have neutropenia where absolute neutrophil count is < 1,000cells/mm3 (NOTE: Even though subject neutrophil count is < 1,000cells/mm3, if it is acute infection, subject maybe possible to participate)
• Chronic Hepatitis B carrier
• Have proof that subject is Hepatitis C carrier or have Hepatitis C antibody
• Immunodeficiency diseases such as HIV positive, AIDS, Bone marrow trasplant or leukemia
• Have medical history of hypersensitive reaction to antibiotics of fluoroquinolones
• Have medical history of seizure or administration of anti-seizure drug in past 1 year before receiving written consent (NOTE: Epilepsy, Convulsions, Myasthenia gravis)
• Medical history of ventricular arrhythmia
• Medical history of QTc prolongation or currently administering drug that delays QTc interval (NOTE: QTc prolongation means QTc interval > 450 msec)
• Complex infections or diseases that can effect study assessment or need long-term antibiotic treatment exceeding 7 days
• Subject who has participated in Clinical trials or Bioequivalence test in past 30 days before receiving written consent
• Clinically significant by observations considered as unsuitable based on medical judgement by investigators where current condition can effect quality of safety or data