Clinical Trials to Evaluate Efficacy and Safety of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg After Multi-dose Oral Administration in Patients With Acute Bacterial Exacerbation of Chronic Obstructive Pulmonary Disease.
Clinical Trials to Evaluate Efficacy and Safety of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg After Multi-dose Oral Administration in Patients With Acute Bacterial Exacerbation of Chronic Obstructive Pulmonary Disease.
The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.
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