An interventional study of High dose or normal dose staphylococcus albicans and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by Qu Yiqing. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Qu Yiqing · Not applicable, Interventional, and Treatment
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.
4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 495 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →This is the only study on the registry with Qu Yiqing as lead sponsor.
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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:
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).
Drug: High dose or normal dose staphylococcus albicans
Participants received placebo (8 tablets each time, 3 times a day, Shandong Qilu Pharmaceutical Co., Ltd., course of treatment 90 days).
Drug: Placebo
8 staphylococcus albicans tablets(0.3 mg) 3 times daily or 4 staphylococcus albicans tablets(0.3 mg)+4 placebo tablets 3 times daily
8 placebo tablets 3 times daily
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.
Time frame: From enrollment to the end of the 1-year follow-up period
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →