| NCT ID | NCT07382986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Chao Yang Hospital |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2030-02-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2026-02-26 with a primary completion date of 2030-02-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Age 40-80 years; Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria. Exclusion Criteria: 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; Unable to accept and wear wearable devices; 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07382986 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07382986 currently recruiting?
Yes, NCT07382986 is actively recruiting participants. Contact the research team at xmjg2002@163.com for enrollment information.
Where is the NCT07382986 trial being conducted?
This trial is being conducted at Hebi, China, Tongliao, China, Mianyang, China, Shihezi, China.
Who is sponsoring the NCT07382986 clinical trial?
NCT07382986 is sponsored by Beijing Chao Yang Hospital. The trial plans to enroll 10,000 participants.
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