Integrative Medicine Program for COPD With Comorbidity Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 4
- 主要终点
- Annual rate of COPD exacerbation
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a major chronic respiratory condition with high prevalence of multimorbidity. COPD and comorbidities interact dynamically, contributing to symptom fluctuation, acute exacerbations, hospitalization, and long-term disease progression.
The IMPACT COPD Cohort (China) is a multicenter prospective observational cohort designed to establish a real-world evidence base for integrative Chinese-Western medicine management of COPD with comorbidities. The cohort integrates conventional clinical assessments (symptoms, questionnaires, spirometry, imaging, and biomarkers) with continuous multisensor digital monitoring (e.g., heart rate, blood pressure, activity, sleep patterns, and other physiological and behavioral measures) and digital Traditional Chinese Medicine (TCM) phenotyping (e.g., tongue, pulse, and facial diagnostics).
The study aims to characterize risk profiles of high-risk populations and patients with confirmed comorbidities, develop and validate prediction models for comorbidity risk and acute exacerbation events, and support evidence generation for long-term management strategies with early screening and risk warning capabilities across hospital, community, and home settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-85 years;
- •Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria.
排除标准
- •Acute exacerbation of COPD within the past 4 weeks;
- •Presence of other pulmonary diseases causing chronic respiratory failure in addition to COPD, such as severe bronchiectasis, pneumoconiosis, post-tuberculosis destroyed lung, chest wall deformity, or neuromuscular disease;
- •Cystic fibrosis or interstitial lung disease;
- •Severe respiratory failure requiring long-term mechanical ventilation via tracheostomy;
- •History of lung or other organ transplantation;
- •Severe pleural disease or chest wall abnormalities that interfere with imaging or pulmonary function assessment;
- •Lung cancer or other malignancy with widespread metastatic disease;
- •Previous or current chemotherapy and/or radiotherapy that may affect pulmonary function or structural assessment;
- •Uncontrolled rheumatic/autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus);
- •HIV infection;
- •Long-term use of immunosuppressive agents or systemic corticosteroids;
- •Severe organ dysfunction, such as severe cardiac, hepatic, or renal failure, or severe pulmonary arterial hypertension;
- •Hospitalization due to myocardial infarction, heart failure, or other cardiovascular events within the past 3 months;
- •Major surgery involving the chest, abdomen, or eyes within the past 3 months;
- •Presence of intrathoracic metallic foreign bodies or implants that interfere with imaging assessment (e.g., pacemaker, implantable cardioverter-defibrillator, metallic prosthetic valves, other metallic devices, or shrapnel);
- •Allergy to any component of the investigational Chinese herbal compound formula(s);
- •Allergy to any component of ICS+LABA+LAMA therapy or to inhaler propellants/excipients;
- •Pregnant or breastfeeding women;
- •Long-term bedridden status, loss of ability to perform activities of daily living, or life expectancy <1 year;
- •Dementia or other cognitive impairment preventing informed consent and follow-up;
- •Living far from the study center, or planned relocation within the next 3 years, making follow-up infeasible;
- •Current participation in another interventional clinical trial involving the respiratory system;
- •Refusal to provide written informed consent.
结局指标
主要结局
Annual rate of COPD exacerbation
时间窗: up to 36 months
Incidence of COPD-related comorbidities (hypertension, coronary artery disease, arrhythmia, heart failure, diabetes, etc.)
时间窗: up to 36 months
次要结局
未报告次要终点