IMPACT COPD Cohort — integrated Chinese–Western care and digital monitoring in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

IMPACT COPD Cohort is a multicenter prospective observational cohort enrolling people with COPD and multimorbidity across several Chinese hospitals. The study combines standard clinical assessments (symptoms, questionnaires, spirometry, imaging, and biomarkers) with continuous multisensor digital monitoring of physiology and behavior and with digital Traditional Chinese Medicine phenotyping (for example, tongue, pulse, and facial diagnostics). Data will be used to characterize risk profiles, symptom fluctuation, and exacerbation patterns in real-world integrative care settings and to support development of predictive models and management pathways. No investigational drug is administered because the study is observational and focuses on data collection and care integration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 40-85 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;
* 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.

Where it's running

• 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

Study contacts

• Study coordinator: Zujin Luo, MD
• Email: xmjg2002@163.com
• Phone: +86-13810497587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.