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NCT Number: NCT07382986

IMPACT COPD Cohort (China)

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hebi Coal Industry Group General Hospital, Hebi, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Annual rate of COPD exacerbation

    Time frame: up to 36 months

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

    Time frame: up to 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Zujin Luo, MD

CONTACT

[email protected]

+86-13810497587

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

Integrative Medicine Program for COPD With Comorbidity Management

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 3, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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