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The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD.
This a randomized, double-blind, parallel, single-center, exploratory trial. 60 patients will be randomized to two treatments: benzalkonium chloride solution treatment or normal saline treatment.The purpose of study is to evaluate the efficacy and safety of benzalkonium chloride solution clearing the oral colonized bacterium in hospitalized patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzalkonium chloride solution | Experimental | Tid, for 7 days. |
|
| Normal saline | Active Comparator | Tid, for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzalkonium chloride solution | Drug | Tid, 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aerobic pathogenic bacterial colonization rate in oral airway | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of oral status | Day 7 | |
| The subjective feeling | Day 7 | |
| The incidence of hospital acquired respiratory infections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyue Li, Professor | Contact | 86 20 83062885 | lishiyue@188.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiyue Li, Professor | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | Tid, 7 days |
|
|
| Day 7 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |