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 purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.

Study Overview

• Status: Unknown
• Conditions: Acute Exacerbations of Chronic Bronchitis
• Intervention / Treatment: Drug: Prulifloxacin; Drug: Levofloxacin Placebo; Drug: Levofloxacin; Drug: Prulifloxacin placebo

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Nei Mongo, China
    • Recruiting
    • Nei Mongo medical University
    • Contact: Liying Cui, Doctor; Phone Number: +86-471-6637524
    • Principal Investigator: Liying Cui, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of treatment	Vital signs, ECG, laboratory examinations and adverse events.	7-10 days

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): June 6, 2014
• Last Update Submitted That Met QC Criteria: June 5, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: prulifloxacin; AECB; Levofloxacin
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin; Fluoroquinolones; Prulifloxacin
• Other Study ID Numbers: Prulifloxacin AECB ZK-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No