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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prulifloxacin | Experimental | Prulifloxacin film-coated tablet : 600 mg/tablet, oral administration of a single tablet. Placebo of levofloxacin hydrochloride tablet, without active components. |
|
| Levofloxacin | Active Comparator | Levofloxacin hydrochloride tablet 500 mg/tablet, oral administration of a tablet daily. Placebo of prulifloxacin film-coated tablet without active components. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prulifloxacin | Drug | 600 mg/tablet, oral administration of a single tablet. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy and safety of prulifloxacin film-coated tablet in the treatment of acute exacerbations of chronic bronchitis. |
| 7-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| safety of treatment | Vital signs, ECG, laboratory examinations and adverse events. | 7-10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nei Mongo medical University | Recruiting | Nei Mongo | China |
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| Levofloxacin |
| Drug |
500 mg/tablet, oral administration of a tablet daily. |
|
| Levofloxacin Placebo | Drug | Placebo of levofloxacin hydrochloride tablet, without active components. |
|
| Prulifloxacin placebo | Drug | Placebo of prulifloxacin film-coated tablet without active components. |
|
| ID | Term |
|---|---|
| C074191 | prulifloxacin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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