Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT05975788
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
750 participants
INTERVENTIONAL
2023-11-30
2025-07-31
Brief Summary
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Detailed Description
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All participants have to sign informed consent. After baseline (V0/V1), participants will be followed up for 12 months with four follow-up visits at 4 weeks ± 14d (V2), 13 weeks ± 14d (V3), 26 weeks ± 14d (V4), and 52 weeks ± 14d (V5). Among them, V2 can be phone interview.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Staphylococcus and Neisseria group
Experimental group will receive Staphylococcus and Neisseria Tablets (0.3mg/tablet) and standard care. Administration Staphylococcus and Neisseria is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months.
Staphylococcus and Neisseria Tablets
Staphylococcus and Neisseria tablets is used as an adjuvant treatment drug for respiratory disease in acute attack period, such as chronic tracheitis, bronchitis and various types of colds. It has been proved to effectively shorten the course of disease. In this study, Staphylococcus and Neisseria tablets will be administered with 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months according to clinicians.
Standard care group
Standard care based on clinical experience without interventions.
No interventions assigned to this group
Interventions
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Staphylococcus and Neisseria Tablets
Staphylococcus and Neisseria tablets is used as an adjuvant treatment drug for respiratory disease in acute attack period, such as chronic tracheitis, bronchitis and various types of colds. It has been proved to effectively shorten the course of disease. In this study, Staphylococcus and Neisseria tablets will be administered with 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months according to clinicians.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Sun Yongchang
Director of Respiratory Department
Principal Investigators
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Yongchang Sun, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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YL20230221
Identifier Type: -
Identifier Source: org_study_id
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