A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Treatment failure rate.
研究概览
简要总结
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial.
This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.
If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.
详细描述
This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial.
This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment.
If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 40 and 80 years old, including 40 and 80 years old, regardless of gender;
- •Clinical records of traceable of the chronic obstructive pulmonary disease history records, after bronchodilator FEV1 less than 80% of the expected value;
- •Comply with the definition of COPD acute exacerbations and with mild and moderate severity assessment;
- •Symptoms of AECOPD time less than 48 h;
- •"Shiduyufei" diagnostic standard;
- •Volunteered for the study, signed informed consent, is willing to cooperate with the visitor.
排除标准
- •Patients showing signs of hospitalization;
- •With respiratory system diseases other than the AECOPD (for example, pneumonia, bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary embolism, or affect the respiratory movement function of neuromuscular diseases, etc.);
- •Patients with severe basic diseases (for example, uncontrolled hypertension diabetes and complicated with heart failure (NYHA class IV), severe arrhythmia, acute coronary syndrome, hemodynamic instability, long-term use of immunosuppressive agents, etc.);
- •With primary disease such as tumor or blood system;
- •With severe liver disease (cirrhosis, portal hypertension, varices bleeding) or renal insufficiency;
- •Pregnant women and breastfeeding mothers, those suspected of being pregnant, or women of childbearing age at risk of pregnancy who have not taken effective contraceptive measures;
- •Dementia, mental disorders, such as unable to read or understand the research content, the information collection;
- •With drug allergy;
- •3 months prior to screening for other interventional clinical research and the research data information;
- •Within 1 week before screening been oral Chinese medicine or other proprietary Chinese medicine treatment;
- •Patient refused to sign a consent form, or estimate adherence is poor, or follow-up possibilities is poor.
研究组 & 干预措施
Experimental group
干预措施: Xuanfei Baidu granule (Drug)
Control group
干预措施: Xuanfei Baidu granule Placebo (Drug)
结局指标
主要结局
Treatment failure rate.
时间窗: within 21 days after enrollment
Admission for acute exacerbation of COPD within 21 days after enrollment (excluding admission for reimbursement).
次要结局
- Duration of acute exacerbation of COPD in this episode.(within 21 days after enrollment)
- Change in the Dyspnea Visual Analog Scale (VAS) score after treatment compared to baseline: Assessing the severity of breathlessness on days 7, 14, and 21 after enrollment.(days 7, 14, and 21 after enrollment)
- Change in the COPD Assessment Test (CAT) score after treatment compared to baseline: Assessing the degree of health impairment on days 7, 14, and 21 after enrollment.(on days 7, 14, and 21 after enrollment)
- Change in the mMRC score after treatment compared to baseline: Assessing the severity of breathlessness on days 7, 14, and 21 after enrollment.(on days 7, 14, and 21 after enrollment)
- Change in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) score after treatment compared to baseline: Assessing daily COPD exacerbation events within 21 days after enrollment.(within 21 days after enrollment)
- Change in the Clinical Symptom Score after treatment compared to baseline: Observing clinical symptom scores on days 7, 14, and 21 after enrollment.(on days 7, 14, and 21 after enrollment)
- Incidence of clinical abnormalities in laboratory examination and electrocardiogram.(within 21 days after enrollment)
- Incidence of adverse events and serious adverse events.(within 21 days after enrollment)
研究者
Cuiling Feng
Professor
Peking University People's Hospital