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

Acute Exacerbations of Chronic Bronchitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02157571
• Other study ID #: Prulifloxacin AECB ZK-004
• Status: Recruiting
• Phase: Phase 3
• First received: June 4, 2014
• Last updated: June 5, 2014
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2014
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Exacerbations of Chronic Bronchitis
• Bronchitis
• Bronchitis, Chronic

Intervention

Drug:
• Prulifloxacin
600 mg/tablet, oral administration of a single tablet.
• Levofloxacin
500 mg/tablet, oral administration of a tablet daily.
• Levofloxacin Placebo
Placebo of levofloxacin hydrochloride tablet, without active components.
• Prulifloxacin placebo
Placebo of prulifloxacin film-coated tablet without active components.

Locations

Country	Name	City	State
China	Nei Mongo medical University	Nei Mongo

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7-10 days	Yes
Secondary	safety of treatment	Vital signs, ECG, laboratory examinations and adverse events.	7-10 days	Yes