IMPACT COPD Cohort (China)

NCT07382986 | Recruiting DMC

• 2 other identifiers: BeijingCYH-2025ZD05489022025ZD0548902
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Multimorbidities

Outcome Measures

Primary Outcomes (2)

• Annual rate of COPD exacerbation

  up to 36 months

• Incidence of COPD-related comorbidities (hypertension, coronary artery disease, arrhythmia, heart failure, diabetes, etc.)

  up to 36 months

Interventions

Real-World Integrative COPD Care and Continuous Multisensor Monitoring OTHER

Participants will receive routine clinical care according to GOLD guideline and local clinical practice. This observational cohort collects longitudinal data through conventional clinical assessments (questionnaires, spirometry, imaging, and biomarkers) and continuous multisensor digital monitoring (e.g., heart rate, blood pressure, activity, and sleep), along with digital Traditional Chinese Medicine (TCM) phenotyping (tongue, pulse, and facial features). No study-mandated therapeutic intervention is assigned.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from multiple hospitals in China. Eligible participants are adults aged 40-80 years with COPD diagnosed according to the 2025 GOLD criteria, identified in outpatient clinics and/or inpatient settings and enrolled for prospective follow-up.

You may qualify if:

• Age 40-80 years; Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (4)

Hebi Coal Industry Group General Hospital

Hebi, Henan, China

RECRUITING

Tongliao Second People's Hospital

Tongliao, Neimeng, China

RECRUITING

Mianyang Third People's Hospital

Mianyang, Sichuan, China

RECRUITING

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zujin Luo, MD

CONTACT

+86-13810497587; xmjg2002@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): February 25, 2030
• Study Completion (Estimated): February 25, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)