Overview

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 Ac

Status:
Unknown status
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lee's Pharmaceutical Limited
Treatments:
Fluoroquinolones
Levofloxacin
Ofloxacin
Prulifloxacin
Criteria
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
)

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.