a study to evaluate efficacy and safety profile of zabofloxacin tablet 400mg and moxifloxacin tablet 400mg

Conditions: Chronic Obstructive Pulmonary Disease

Summary: 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.

Eligibility criteria:
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) \ 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

Keywords: acute exacerbation of chronic obstructive pulmonary disease acute exacerbation chronic obstructive pulmonary disease(copd) zabofloxacin moxifloxacin