Status:
UNKNOWN
Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Peking University Third Hospital
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a multi-center, prospective study. This study aims to investigate the incidence of acute exacerbation within 12 months, as well as the safety of Staphylococcus and Neisseria Tablets on patient...
Detailed Description
A total of 750 eligible COPD patients were enrolled, and were randomly divided into experimental group and control group with a ratio of 2:1. Experimental group will receive Staphylococcus and Neisser...
Eligibility Criteria
Inclusion
- 18-80 years, males and females.
- Clinical diagnosis of COPD, defined as FEV1/FVC\<70% after inhaling bronchodilators.
- At least 1 moderate to severe acute exacerbation of COPD in the past year.
- Patient or their legal agent sign informed consent with a date after understanding the purpose and procedures of the research, and be willing to participate in the study.
Exclusion
- Patients with active pulmonary tuberculosis, asthma, or uncontrolled advanced malignant tumors; or after partial, lobar, or total pneumonectomy.
- Patients with acute cardio cerebral vascular disease such as acute myocardial infarction, acute stroke and acute heart failure.
- Patients with liver failure or renal failure and need blood purification treatment.
- Patients with rheumatic diseases and autoimmune diseases.
- Have participated or currently in interventional clinical trials within 30 days.
- Patients with previous (within 3 months before signing the informed consent) or current use of immunomodulatory drugs (including thymosin, thymosin, interferon, transfer factor, BCG vaccine polysaccharide, and any kind of bacterial extract such as Biostim, pneumonia vaccine, and influenza vaccine).
- Currently pregnant or breast-feeding women, or those who have fertility but cannot take contraceptive measures during the study period.
- Other conditions that are not suitable for the trials according to investigator's judgement.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT05975788
Start Date
November 1 2023
End Date
July 1 2025
Last Update
November 18 2023
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191