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| Name | Class |
|---|---|
| Qilu Pharmaceutical Co., Ltd. | INDUSTRY |
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It is planned to enroll 495 acute exacerbation of chronic obstructive pulmonary disease patients, and they will be randomly assigned to the high-dose test group, normal dose test group or control group at a ratio of 1:1:1, with 165 patients in each group. The course of treatment is 90 days, and the total follow-up time is one year. The purpose of the study is to evaluate the effectiveness and safety of different doses of bacterial lysates (Staphylococcus and Neisseria Tablets) in the treatment of acute exacerbation of chronic obstructive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ntaphylococcus albicans tablets | Experimental | Participants received High-dose Staphylococcus albicans tablets (0.3 mg/tablet, 8 tablets each time, 3 times a day, Qilu Pharmaceutical Co., Ltd., course of treatment 90 days) or Normal-doseStaphylococcus albicans tablets (0.3 mg/tablet, 4 tablets each time, 3 times a day, Qilu Pharmaceutical Co., Ltd., course of treatment 90 days)+ placebo (4 tablets each time, 3 times a day, Qilu Pharmaceutical Co., Ltd., course of treatment 90 days). |
|
| Placebo | Placebo Comparator | Participants received placebo (8 tablets each time, 3 times a day, Shandong Qilu Pharmaceutical Co., Ltd., course of treatment 90 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose or normal dose staphylococcus albicans | Drug | 8 staphylococcus albicans tablets(0.3 mg) 3 times daily or 4 staphylococcus albicans tablets(0.3 mg)+4 placebo tablets 3 times daily |
| Measure | Description | Time Frame |
|---|---|---|
| Number of acute exacerbations of chronic obstructive pulmonary disease in 1 year | The number of acute exacerbations of COPD in one year since the patients were enrolled in the group. | From enrollment to the end of the 1-year follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
The investigator judges that the patient has serious diseases that are not suitable for inclusion in this study, including but not limited to the following diseases:
During the acute exacerbation hospitalization, use intravenous hormone for more than 7 days and/or continuous hospitalization for more than 15 days;
Have fertility and have not taken effective contraceptive measures (contraceptive methods include barrier contraception or hormonal contraception; barrier contraception includes: cervical cap, condom, intrauterine device, vaginal sponge, spermicide; hormonal contraception includes: contraceptive) ï¼› According to the judgment of the investigator, the patient is not suitable for research observation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiqing Qu | Contact | +8618560082829 | quyiqing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yiqing Qu | Qilu Hospital of Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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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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| Placebo | Drug | 8 placebo tablets 3 times daily |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |