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

NCT02157571 | Unknown Phase 3

• 1 other identifier: Prulifloxacin AECB ZK-004
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbations of Chronic Bronchitis

Keywords

prulifloxacin; AECB; Levofloxacin

Outcome Measures

Primary Outcomes (1)

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

  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

  7-10 days

Secondary Outcomes (1)

• safety of treatment

  7-10 days

Study Arms (2)

Prulifloxacin

EXPERIMENTAL

Prulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet. Placebo of levofloxacin hydrochloride tablet, without active components.

Drug: Prulifloxacin; Drug: Levofloxacin Placebo

Levofloxacin

ACTIVE COMPARATOR

Levofloxacin hydrochloride tablet 500 mg/tablet, oral administration of a tablet daily. Placebo of prulifloxacin film-coated tablet without active components.

Drug: Levofloxacin; Drug: Prulifloxacin placebo

Interventions

Prulifloxacin DRUG

600 mg/tablet, oral administration of a single tablet.

Prulifloxacin

Levofloxacin DRUG

500 mg/tablet, oral administration of a tablet daily.

Levofloxacin

Levofloxacin Placebo DRUG

Placebo of levofloxacin hydrochloride tablet, without active components.

Prulifloxacin

Prulifloxacin placebo DRUG

Placebo of prulifloxacin film-coated tablet without active components.

Levofloxacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is willing to participate in the study and gives the signature of informed consent;
• In and out-patients (aged 18-70 years old), male or female;
• Patient receives no effective antibacterial therapy or the therapy has no remarkable efficacy, or positive bacterial test result in the past 72 hours;
• Diagnosed as mild to moderate acute exacerbation of chronic bronchitis patients (see \<Severity Evaluation Criteria Table\>)
• 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.

You may not qualify if:

• Patient hypersensitive to quinolones or with allergic constitution;
• Patient with severe condition which need combination with other antibacterial agents;
• Concurrent infections in other organs or system;
• 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;
• 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;
• Patient with severe hematologic disease or central nervous system disease or convulsion history, with mental status unable to coordinate;
• Patient with malignant tumor or other severe background disease;
• Patient with severe immunodeficiency;
• A history of tendon;
• Known pregnancy or lactation;
• Prulifloxacin contains lactose, therefore, patients with a rare genetic disease such as galactose intolerance, Lapp lactase deficiency or glucose - galactose malabsorption cannot be enrolled;
• Participation in other clinical trials within 3 months before screening or currently on any investigational therapy.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Nei Mongo medical University

Nei Mongo, China

RECRUITING

MeSH Terms

Interventions

prulifloxacin; Levofloxacin

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

CN (1)