A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg

A Phase 3, Multicenter, Double Blind, Active Controlled, Randomized Study to Evaluate the Efficacy and Safety of Zabofloxacin for Patients with acute bacterial exacerbation of Chronic obstructive pulmonary disease.

Inclusion criteria

• Adult male or female same or older than age of 40
• Severity of acute exacerbation of Chronic obstructive pulmonary disease(COPD) must suit oral administration treatment
• Diagnosed as COPD before receiving written informed consent and outcome measure of spirometry testing confirmed as [Ratio of Forced Expiratory Volume in 1 second(FEV1) to Forced Vital Capacity(FVC)](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 Tubule ligation and menopause are excluded from the study)
• Subject who can agree and sign written informed consent form approved by Institutional Review Board(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) Creatinine Clearance(CCr) < 50 mL/min (ii) Blood Urea Nitrogen(BUN) ≥ 30 mg/dl (iii) Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 3 x Upper Limit Normal(ULN) (iv) Total bilirubin > 2 x ULN (v) Alkaline Phosphatase(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 transplant 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