Clinical trial NCT01658020: A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Acute exacerbation of Chronic obstructive pulmonary disease
Acute Exacerbation
Chronic obstructive pulmonary disease(COPD)
Zabofloxacin
Moxifloxacin
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chonbuk National University Hospital
name: Chosun University Hospital
name: Bundang CHA Hospital
name: Chungbuk National University
name: Kangdong Sacred Heart Hospital
name: Hanyang University
name: Asan Medical Center
name: Gachon University Gil Medical Center
name: The Catholic University of Korea
name: Konyang University Hospital
name: KangWon National University Hospital
name: Gyeongsang National University Hospital
name: Kyunghee University Medical Center
name: Korea University Anam Hospital
name: DongGuk University
name: Severance Hospital
name: Yeungnam University Hospital
name: Ulsan University Hospital
name: Ewha Womans University Mokdong Hospital
name: Inje University
name: Chonnam National University Hospital
name: Catholic University of Korea Saint Paul's Hospital
name: Incheon St.Mary's Hospital
name: Masan Samsung Hospital, South Korea
name: Konkuk University Medical Center
name: Keimyung University Dongsan Medical Center
name: Wonju Severance Christian Hospital
name: Hallym University Medical Center
name: Ajou University
name: Chungnam National University Hospital
First posted: 2012-08-06
Enrollment: 345
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Response in the Clinical Populations
timeFrame: 10days
Secondary outcomes:
measure: Clinical Response in the Clinical Population
timeFrame: 36days
measure: Clinical Cure Rate in the Microbiological Per Protocol(PP) Population
timeFrame: 10days
measure: Microbiological Response Rate
timeFrame: 10days
measure: Change in EXACT-PRO Score
timeFrame: 10 days
measure: Change in CAT Scores
timeFrame: 10 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Yeon-Mok Oh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Sang-Do Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.