Chronic Obstructive Pulmonary DiseasePhase 3DW224-III-3NCT01658020
A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg
A Phase 3 study testing Zabofloxacin and Moxifloxacin in people with Chronic Obstructive Pulmonary Disease, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Zabofloxacin and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Zabofloxacin, Moxifloxacin
- Keywords
- Acute exacerbation of Chronic obstructive pulmonary disease, Acute Exacerbation, Chronic obstructive pulmonary disease(COPD), Zabofloxacin, Moxifloxacin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZabofloxacinDrug
Also called DW224
Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days
MoxifloxacinDrug
Also called Avelox
Moxifloxacin 400mg tablet P.O. once daily for 7days
| Study group | Role | What they receive |
|---|---|---|
| DW224 | Experimental | Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days Receives: Drug: Zabofloxacin |
| Avelox | Active comparator | Moxifloxacin 400mg tablet P.O. once daily for 7days Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Yeon-Mok Oh, M.D., Principal investigator, Asan Medical CenterSang-Do Lee, M.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658020
- Sponsor's protocol ID
- DW224-III-3
- Acronym
- DW224-III-3
- Status last verified
- Oct 2014
- First submitted
- 25 Jul 2012
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 31920016
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01658020
- Acronym / sponsor ID
- DW224-III-3 / DW224-III-3
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Acute exacerbation of Chronic obstructive pulmonary disease, Acute Exacerbation, Chronic obstructive pulmonary disease(COPD), Zabofloxacin, Moxifloxacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- 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
- Study start
- Aug 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DW224 | Experimental | Drug: ZabofloxacinZabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days |
| Avelox | Active comparator | Drug: MoxifloxacinMoxifloxacin 400mg tablet P.O. once daily for 7days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Organic gastrointestinal disorder having abnormal absorption problem condition in past 6 months before receiving written consent (NOTE: Active Crohn's disease, active ulcerative colitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZabofloxacinAlso: DW224Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days | Drug | DW224 |
| MoxifloxacinAlso: AveloxMoxifloxacin 400mg tablet P.O. once daily for 7days | Drug | Avelox |
Primary outcome
Clinical Response in the Clinical Populations
Time frame: 10days
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.
5 secondary outcomes
Clinical Response in the Clinical Population
Time frame: 36days
Clinical Cure Rate in the Microbiological Per Protocol(PP) Population
Time frame: 10days
Microbiological Response Rate
Time frame: 10days
Change in EXACT-PRO Score
Time frame: 10 days
Change in CAT Scores
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31920016Yoon 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.
- Asan Medical CenterLink provided by the sponsor.
- Dong Wha Pharm. Co. Ltd.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeon-Mok Oh, M.D. principal investigator
Asan Medical Center
Sang-Do Lee, M.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zabofloxacin and Moxifloxacin in people with Chronic Obstructive Pulmonary Disease, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response in the Clinical Populations (time frame: 10days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01658020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.