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

Phase 3

• Conditions: Acute Exacerbations of Chronic Bronchitis
• Interventions: Drug: Prulifloxacin; Drug: Levofloxacin; Drug: Prulifloxacin placebo; Drug: Levofloxacin Placebo

• Registration Number: NCT02157571
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Study First Posted: 2014-06-06
• Last Update Posted: 2014-06-06
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy and safety of prulifloxacin film-coated tablet in the treatment of acute exacerbations of chronic bronchitis.	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

Name	Time	Method
safety of treatment	7-10 days	Vital signs, ECG, laboratory examinations and adverse events.

Trial Locations

Locations (1)

Nei Mongo medical University; 🇨🇳 Nei Mongo, China