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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Zabofloxacin; Drug: Moxifloxacin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 345
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DW224; Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days	Drug: Zabofloxacin; Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days; Other Names: DW224
Active Comparator: Avelox; Moxifloxacin 400mg tablet P.O. once daily for 7days	Drug: Moxifloxacin; Moxifloxacin 400mg tablet P.O. once daily for 7days; Other Names: Avelox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response in the Clinical Populations	Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.	10days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response in the Clinical Population	Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.	36days
Clinical Cure Rate in the Microbiological Per Protocol(PP) Population	Clinical response corresponding clinical cure in the microbiological per-protocol population. Microbiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects.	10days
Microbiological Response Rate	Microbiological response rate in the microbiological per protocol(PP) population. Microbiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects.	10days
Change in EXACT-PRO Score	The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit. EXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD. EXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation.	10 days
Change in CAT Scores	The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit. CAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life. CAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point. The scores of each question item were summed into the total score, which had values between 0 and 40.	10 days

Collaborators and Investigators

• Sponsor: Dong Wha Pharmaceutical Co. Ltd.
• Collaborators: Chonbuk National University Hospital; Asan Medical Center; Chonnam National University Hospital; Ulsan University Hospital; Korea University Anam Hospital; Gachon University Gil Medical Center; Inje University; Gyeongsang National University Hospital; Hanyang University; Yeungnam University Hospital; Konkuk University Medical Center; The Catholic University of Korea; Severance Hospital; Bundang CHA Hospital; Ewha Womans University Mokdong Hospital; Keimyung University Dongsan Medical Center; Chungbuk National University; Hallym University Medical Center; Chungnam National University Hospital; Wonju Severance Christian Hospital; Incheon St.Mary's Hospital; DongGuk University; Kyunghee University Medical Center; KangWon National University Hospital; Chosun University Hospital; Konyang University Hospital; Kangdong Sacred Heart Hospital; Catholic University of Korea Saint Paul's Hospital; Masan Samsung Hospital, South Korea; Ajou University
• Investigators: Principal Investigator: Yeon-Mok Oh, M.D., Asan Medical Center; Principal Investigator: Sang-Do Lee, M.D., Asan Medical Center

Publications and helpful links

General Publications

• Yoon S, Kim TE, Kim TH, Na JO, Shin KC, Rhee CK, Jung SS, Choe KH, Yoo KH. Clinical Role of the Chronic Obstructive Pulmonary Disease Assessment Test in Prediction of the Response to Treatment for Exacerbations. J Korean Med Sci. 2020 Jan 13;35(2):e10. doi: 10.3346/jkms.2020.35.e10.

Helpful Links

• Asan Medical Center
• Dong Wha Pharm. Co. Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Moxifloxacin; Acute exacerbation of Chronic obstructive pulmonary disease; Acute Exacerbation; Chronic obstructive pulmonary disease(COPD); Zabofloxacin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: DW224-III-3