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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02157571
Recruitment Status : Unknown
Verified June 2014 by Lee's Pharmaceutical Limited.
Recruitment status was:  Recruiting
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Exacerbations of Chronic Bronchitis Drug: Prulifloxacin Drug: Levofloxacin Drug: Levofloxacin Placebo Drug: Prulifloxacin placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Prulifloxacin

Prulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet.

Placebo of levofloxacin hydrochloride tablet, without active components.

Drug: Prulifloxacin
600 mg/tablet, oral administration of a single tablet.

Drug: Levofloxacin Placebo
Placebo of levofloxacin hydrochloride tablet, without active components.

Active Comparator: Levofloxacin

Levofloxacin hydrochloride tablet 500 mg/tablet, oral administration of a tablet daily.

Placebo of prulifloxacin film-coated tablet without active components.

Drug: Levofloxacin
500 mg/tablet, oral administration of a tablet daily.

Drug: Prulifloxacin placebo
Placebo of prulifloxacin film-coated tablet without active components.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. safety of treatment [ Time Frame: 7-10 days ]
    Vital signs, ECG, laboratory examinations and adverse events.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is willing to participate in the study and gives the signature of informed consent;
  2. In and out-patients (aged 18-70 years old), male or female;
  3. Patient receives no effective antibacterial therapy or the therapy has no remarkable efficacy, or positive bacterial test result in the past 72 hours;
  4. Diagnosed as mild to moderate acute exacerbation of chronic bronchitis patients (see <Severity Evaluation Criteria Table>)
  5. 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.

Exclusion Criteria:

  1. Patient hypersensitive to quinolones or with allergic constitution;
  2. Patient with severe condition which need combination with other antibacterial agents;
  3. Concurrent infections in other organs or system;
  4. 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;
  5. 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;
  6. Patient with severe hematologic disease or central nervous system disease or convulsion history, with mental status unable to coordinate;
  7. Patient with malignant tumor or other severe background disease;
  8. Patient with severe immunodeficiency;
  9. A history of tendon;
  10. Known pregnancy or lactation;
  11. Prulifloxacin contains lactose, therefore, patients with a rare genetic disease such as galactose intolerance, Lapp lactase deficiency or glucose - galactose malabsorption cannot be enrolled;
  12. Participation in other clinical trials within 3 months before screening or currently on any investigational therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02157571

Nei Mongo medical University Recruiting
Nei Mongo, China
Contact: Liying Cui, Doctor    +86-471-6637524      
Principal Investigator: Liying Cui, Doctor         
Sponsors and Collaborators
Lee's Pharmaceutical Limited

Responsible Party: Lee's Pharmaceutical Limited Identifier: NCT02157571     History of Changes
Other Study ID Numbers: Prulifloxacin AECB ZK-004
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Lee's Pharmaceutical Limited:

Additional relevant MeSH terms:
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors