Acute Exacerbations of Chronic BronchitisPhase 3NCT02157571
A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control
A Phase 3 study testing Prulifloxacin and Levofloxacin in people with Acute Exacerbations of Chronic Bronchitis, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
The purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Exacerbations of Chronic Bronchitis
- What is being tested?
- Prulifloxacin and Levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is willing to participate in the study and gives the signature of informed consent;
- In and out-patients (aged 18-70 years old), male or female;
- Patient receives no effective antibacterial therapy or the therapy has no remarkable efficacy, or positive bacterial test result in the past 72 hours;
- Diagnosed as mild to moderate acute exacerbation of chronic bronchitis patients (see <Severity Evaluation Criteria Table>)
- Within 48 hours prior to the study, women of child-bearing age have a negative urine pregnancy test and is willing to use efficient measures of contraception to avoid pregnancy during the study.
Who cannot join
- Patient hypersensitive to quinolones or with allergic constitution;
- Patient with severe condition which need combination with other antibacterial agents;
- Concurrent infections in other organs or system;
- Patient with severe heart, liver or kidney disease, or Q-T prolongation of over 450 ms, serum AST or ALT more than twice as high as the upper limit of normal or Cr over the upper limit of normal;
- With any of the following diseases: active tuberculosis, bronchiectasis, lung abscess, aspiration pneumonia, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary addicted acidic granulocyte infiltration and pulmonary vasculitis syndrome;
- Patient with severe hematologic disease or central nervous system disease or convulsion history, with mental status unable to coordinate;
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- Patient with malignant tumor or other severe background disease;
- Patient with severe immunodeficiency;
- A history of tendon;
- Known pregnancy or lactation;
- Prulifloxacin contains lactose, therefore, patients with a rare genetic disease such as galactose intolerance, Lapp lactase deficiency or glucose - galactose malabsorption cannot be enrolled;
- Participation in other clinical trials within 3 months before screening or currently on any investigational therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nei Mongo medical University
Nei Mongo
Liying Cui, Doctor, +86-471-6637524
Liying Cui, Doctor
About this study
The purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.
- Being tested
- Prulifloxacin, Levofloxacin, Levofloxacin Placebo, Prulifloxacin placebo
- Keywords
- prulifloxacin, AECB, Levofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrulifloxacinDrug
600 mg/tablet, oral administration of a single tablet.
LevofloxacinDrug
500 mg/tablet, oral administration of a tablet daily.
Levofloxacin PlaceboDrug
Placebo of levofloxacin hydrochloride tablet, without active components.
Prulifloxacin placeboDrug
Placebo of prulifloxacin film-coated tablet without active components.
| Study group | Role | What they receive |
|---|---|---|
| Prulifloxacin | Experimental | Prulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet.
Placebo of levofloxacin hydrochloride tablet, without active components. Receives: Drug: Prulifloxacin; Drug: Levofloxacin Placebo |
| Levofloxacin | Active comparator | Levofloxacin hydrochloride tablet 500 mg/tablet, oral administration of a tablet daily.
Placebo of prulifloxacin film-coated tablet without active components. Receives: Drug: Levofloxacin; Drug: Prulifloxacin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and safety of prulifloxacin film-coated tablet in the treatment of acute exacerbations of chronic bronchitis.
- Clinical efficacy: consists of clinical evaluation which expressed as clinical cure and clinical failure.
- Bacteriological efficacy: consists of eradication, supposed eradication, persistence, supposed persistence, partial eradication,;
- Comprehensive therapeutic efficacy: consists of cure and failure
Measured: 7-10 days
Secondary outcomes (1)
safety of treatment
Vital signs, ECG, laboratory examinations and adverse events.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbations of Chronic BronchitisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157571
- Sponsor's protocol ID
- Prulifloxacin AECB ZK-004
- Status last verified
- Jun 2014
- First submitted
- 4 Jun 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control
- ClinicalTrials.gov ID
- NCT02157571
- Acronym / sponsor ID
- Prulifloxacin AECB ZK-004
- Keywords
- prulifloxacin, AECB, Levofloxacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
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 use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prulifloxacin | Experimental | Drug: Prulifloxacin, Drug: Levofloxacin PlaceboPrulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet. Placebo of levofloxacin hydrochloride tablet, without active components. |
| Levofloxacin | Active comparator | Drug: Levofloxacin, Drug: Prulifloxacin placeboLevofloxacin hydrochloride tablet 500 mg/tablet, oral administration of a tablet daily. Placebo of prulifloxacin film-coated tablet without active components. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is willing to participate in the study and gives the signature of informed consent;
- In and out-patients (aged 18-70 years old), male or female;
- Patient receives no effective antibacterial therapy or the therapy has no remarkable efficacy, or positive bacterial test result in the past 72 hours;
- Diagnosed as mild to moderate acute exacerbation of chronic bronchitis patients (see <Severity Evaluation Criteria Table>)
- Within 48 hours prior to the study, women of child-bearing age have a negative urine pregnancy test and is willing to use efficient measures of contraception to avoid pregnancy during the study.
Key exclusion criteria (12 listed)
- Patient hypersensitive to quinolones or with allergic constitution;
- Patient with severe condition which need combination with other antibacterial agents;
- Concurrent infections in other organs or system;
- Patient with severe heart, liver or kidney disease, or Q-T prolongation of over 450 ms, serum AST or ALT more than twice as high as the upper limit of normal or Cr over the upper limit of normal;
- With any of the following diseases: active tuberculosis, bronchiectasis, lung abscess, aspiration pneumonia, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary addicted acidic granulocyte infiltration and pulmonary vasculitis syndrome;
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 |
|---|---|---|
| Prulifloxacin600 mg/tablet, oral administration of a single tablet. | Drug | Prulifloxacin |
| Levofloxacin500 mg/tablet, oral administration of a tablet daily. | Drug | Levofloxacin |
| Levofloxacin PlaceboPlacebo of levofloxacin hydrochloride tablet, without active components. | Drug | Prulifloxacin |
| Prulifloxacin placeboPlacebo of prulifloxacin film-coated tablet without active components. | Drug | Levofloxacin |
Primary outcome
To evaluate the efficacy and safety of prulifloxacin film-coated tablet in the treatment of acute exacerbations of chronic bronchitis.
Time frame: 7-10 days
1. Clinical efficacy: consists of clinical evaluation which expressed as clinical cure and clinical failure. 2. Bacteriological efficacy: consists of eradication, supposed eradication, persistence, supposed persistence, partial eradication,; 3. Comprehensive therapeutic efficacy: consists of cure and failure
1 secondary outcome
safety of treatment
Time frame: 7-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
Related trials for Acute Exacerbations of Chronic Bronchitis
Enrolling by invitationObservational study
The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease
COPD, COPD Exacerbation Acute
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.
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 Prulifloxacin and Levofloxacin in people with Acute Exacerbations of Chronic Bronchitis, run by Lee's Pharmaceutical Limited at 1 site in China.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Jun 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy and safety of prulifloxacin film-coated tablet in the treatment of acute exacerbations of chronic bronchitis. (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2014; AzTrials last refreshed its copy on 28 Oct 2026.