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

Study Overview
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Brief Summary
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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
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Acute Exacerbations of Chronic Bronchitis

Intervention / Treatment
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* Drug: Prulifloxacin
* Drug: Levofloxacin
* Drug: Levofloxacin Placebo
* Drug: Prulifloxacin placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prulifloxacin<br>Prulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet. Placebo of levofloxacin hydrochloride tablet, without active components. | Drug: Prulifloxacin<br>* 600 mg/tablet, oral administration of a single tablet.<br>Drug: Levofloxacin Placebo<br>* Placebo of levofloxacin hydrochloride tablet, without active components.<br>|
| Active Comparator: Levofloxacin<br>Levofloxacin hydrochloride tablet 500 mg/tablet, oral administration of a tablet daily. Placebo of prulifloxacin film-coated tablet without active components. | Drug: Levofloxacin<br>* 500 mg/tablet, oral administration of a tablet daily.<br>Drug: Prulifloxacin placebo<br>* Placebo of prulifloxacin film-coated tablet without active components.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prulifloxacin, AECB, Levofloxacin