Effect of Staphylococcus and Neisseria Tablets on Clinical Outcome Among Patients With Chronic Obstructive Pulmonary Disease: A Multi-center, Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- AECOPD (Acute exacerbation COPD)
研究概览
简要总结
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.
详细描述
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 Neisseria Tablets (0.3mg/tablet) and standard care. Drug administration is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months. Control group will receive standard care without interventions.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Staphylococcus and Neisseria Tablets (Drug)
结局指标
主要结局
AECOPD (Acute exacerbation COPD)
时间窗: 12 months
Incidence of AECOPD within 12 months. Diagnosis of AECOPD is based on the Chinese Expert Consensus on Diagnosis and Management of AECOPD (2023 version). * Mild：No respiratory failure. Respiratory rate 20-30 times/min; no use of ventilator or change in mental state; fraction of inspiration O2 (FiO2) improves after supplemental oxygen; no increase in partial pressure of CO2 in artery (PaCO2). * Moderate：Acute respiratory failure but not life threatening. Respiratory rate \> 30 times/min; use of ventilator or change in mental state; FiO2\>35% after supplemental oxygen, improved hypoxemia; hypercapnia, PaCO2 increases from baseline or increases to 50-60mmHg. * Severe：Acute respiratory failure and life threatening. Respiratory rate \> 30 times/min; use of ventilator; acute changes in mental state; FiO2\>45% after supplemental oxygen, no improvement in hypoxemia; PaCO2 increases by \> 60mmHg from baseline or acidosis.
次要结局
- Moderate or severe AECOPD(12 months)
- TDI（Transition Dyspnea Index）(1 month, 3 months, 6 months, and 12 months)
- Changes in the use of inhaled drugs(1 month, 3 months, 6 months, and 12 months)
- CET（Cough Evaluation Test）(1 month, 3 months, 6 months, and 12 months)
- Cough severity VAS（Visual Analog Scale）(1 month, 3 months, 6 months, and 12 months)
- Pulmonary function(6 months, and 12 months)
- Changes in the use of anti-infective drugs(12 months)
- Change in frequency of AECOPD(12 months)
- Hospitalization due to severe AECOPD(12 months)
- mMRC（modified Medical Research Council）(1 month, 3 months, 6 months, and 12 months)
- CAT（COPD Assessment Test）(1 month, 3 months, 6 months, and 12 months)
- Adverse events(12 months)
研究者
Sun Yongchang
Director of Respiratory Department
Peking University Third Hospital