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NCT07382986Recruiting

IMPACT COPD Cohort (China)

Integrative Medicine Program for COPD With Comorbidity Management

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
26 Jan 2026
Start date
26 Feb 2026
Primary completion date
25 Feb 2030
Lead sponsor
Beijing Chao Yang Hospital
Diseases
COPD
NCT number
NCT07382986

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 26 Feb 2026 to the primary completion date, 25 Feb 2030
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or current chemotherapy and/or radiotherapy that may affect pulmonary function or structural assessment;
  • Long-term use of immunosuppressive agents or systemic corticosteroids;
  • 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);

Other illness

  • 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;
  • Uncontrolled rheumatic/autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus);
  • HIV infection;
  • 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;
  • 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;
  • Dementia or other cognitive impairment preventing informed consent and follow-up;

Other

  • Acute exacerbation of COPD within the past 4 weeks;
  • Pregnant or breastfeeding women;
  • Long-term bedridden status, loss of ability to perform activities of daily living, or life expectancy \<1 year;
  • 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.

Who the study is looking for

  • Age 40-85 years;
  • Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria.

Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hebi Coal Industry Group General Hospital
Coordinator of this site? Confirm its status
HebiChinaRecruiting
Mianyang third people's hospital
Coordinator of this site? Confirm its status
MianyangChinaRecruiting
The First Affiliated Hospital of Shihezi University
Coordinator of this site? Confirm its status
ShiheziChinaRecruiting
Tongliao Second People's Hospital
Coordinator of this site? Confirm its status
TongliaoChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.