A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Zabofloxacin; Moxifloxacin
Intervention description: Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days; Moxifloxacin 400mg tablet P.O. once daily for 7days
Intervention MeSH terms: Moxifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 345.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Acute exacerbation of Chronic obstructive pulmonary disease; Acute Exacerbation; Chronic obstructive pulmonary disease(COPD); Zabofloxacin; Moxifloxacin

Summary:

      The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple
      dose of Zabofloxacin Tablet 400 mg.
    

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) < 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