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.