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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zabofloxacin
Moxifloxacin
Sponsored by
Dong Wha Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Acute exacerbation of Chronic obstructive pulmonary disease, Acute Exacerbation, Chronic obstructive pulmonary disease(COPD), Zabofloxacin, Moxifloxacin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DW224

Avelox

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
July 25, 2012
Last Updated
October 2, 2014
Sponsor
Dong Wha Pharmaceutical Co. Ltd.
Collaborators
Chonbuk National University Hospital, Chosun University Hospital, Bundang CHA Hospital, Chungbuk National University, Kangdong Sacred Heart Hospital, Hanyang University, Asan Medical Center, Gachon University Gil Medical Center, The Catholic University of Korea, Konyang University Hospital, KangWon National University Hospital, Gyeongsang National University Hospital, Kyunghee University Medical Center, Korea University Anam Hospital, DongGuk University, Severance Hospital, Yeungnam University Hospital, Ulsan University Hospital, Ewha Womans University Mokdong Hospital, Inje University, Chonnam National University Hospital, Catholic University of Korea Saint Paul's Hospital, Incheon St.Mary's Hospital, Masan Samsung Hospital, South Korea, Konkuk University Medical Center, Keimyung University Dongsan Medical Center, Wonju Severance Christian Hospital, Hallym University Medical Center, Ajou University, Chungnam National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01658020
Brief Title
A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg
Acronym
DW224-III-3
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong Wha Pharmaceutical Co. Ltd.
Collaborators
Chonbuk National University Hospital, Chosun University Hospital, Bundang CHA Hospital, Chungbuk National University, Kangdong Sacred Heart Hospital, Hanyang University, Asan Medical Center, Gachon University Gil Medical Center, The Catholic University of Korea, Konyang University Hospital, KangWon National University Hospital, Gyeongsang National University Hospital, Kyunghee University Medical Center, Korea University Anam Hospital, DongGuk University, Severance Hospital, Yeungnam University Hospital, Ulsan University Hospital, Ewha Womans University Mokdong Hospital, Inje University, Chonnam National University Hospital, Catholic University of Korea Saint Paul's Hospital, Incheon St.Mary's Hospital, Masan Samsung Hospital, South Korea, Konkuk University Medical Center, Keimyung University Dongsan Medical Center, Wonju Severance Christian Hospital, Hallym University Medical Center, Ajou University, Chungnam National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Acute exacerbation of Chronic obstructive pulmonary disease, Acute Exacerbation, Chronic obstructive pulmonary disease(COPD), Zabofloxacin, Moxifloxacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DW224
Arm Type
Experimental
Arm Description
Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days
Arm Title
Avelox
Arm Type
Active Comparator
Arm Description
Moxifloxacin 400mg tablet P.O. once daily for 7days
Intervention Type
Drug
Intervention Name(s)
Zabofloxacin
Other Intervention Name(s)
DW224
Intervention Description
Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Other Intervention Name(s)
Avelox
Intervention Description
Moxifloxacin 400mg tablet P.O. once daily for 7days
Primary Outcome Measure Information:
Title
Clinical Response in the Clinical Populations
Description
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.
Time Frame
10days
Secondary Outcome Measure Information:
Title
Clinical Response in the Clinical Population
Description
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.
Time Frame
36days
Title
Clinical Cure Rate in the Microbiological Per Protocol(PP) Population
Description
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.
Time Frame
10days
Title
Microbiological Response Rate
Description
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.
Time Frame
10days
Title
Change in EXACT-PRO Score
Description
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.
Time Frame
10 days
Title
Change in CAT Scores
Description
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.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeon-Mok Oh, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Do Lee, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31920016
Citation
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.
Results Reference
derived
Links:
URL
http://medical.amc.seoul.kr/medservice/main/main.do
Description
Asan Medical Center
URL
http://www.dong-wha.co.kr/dw_main.asp
Description
Dong Wha Pharm. Co. Ltd.

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

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