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Clinical trial

Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease: A Multi-center, Prospective Study

ID
Name
YL20230221
Description
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 patients with chronic obstructive pulmonary disease (COPD). In addition, this study investigates the improvement of hospitalization, improvement of pulmonary function, improvement of symptoms, and the use of anti-Infective drugs among COPD patients.
Trial arms
Trial start
2023-11-01
Estimated PCD
2025-02-01
Trial end
2025-07-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Staphylococcus and Neisseria group
Size
750
Primary endpoint
AECOPD (Acute exacerbation COPD)
12 months
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 750, 'type': 'ESTIMATED'}}
Updated at
2023-11-18

1 organization

1 product

1 indication

Organization
Peking University Third Hospital
Product
Staphylococcus and Neisseria
Indication
Chronic Obstructive Pulmonary Disease