Actively Recruiting

Age: 40Years - 80Years
All Genders
NCT07382986

IMPACT COPD Cohort (China)

Led by Beijing Chao Yang Hospital · Updated on 2026-03-19

10000

Participants Needed

4

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

IMPACT COPD Cohort (China)

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 80 years
  • Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria
Not Eligible

You will not qualify if you...

  • Acute exacerbation of COPD within the past 4 weeks
  • Other lung diseases causing chronic respiratory failure, 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 interfering with imaging or lung function tests
  • Lung cancer or other widespread metastatic malignancy
  • Previous or current chemotherapy or radiotherapy affecting lung function or structure
  • Uncontrolled rheumatic or autoimmune diseases like rheumatoid arthritis or systemic lupus erythematosus
  • HIV infection
  • Long-term use of immunosuppressive drugs or systemic corticosteroids
  • Severe organ dysfunction such as severe heart, liver, kidney failure, or severe pulmonary arterial hypertension
  • Hospitalization for myocardial infarction, heart failure, or other cardiovascular events within the past 3 months
  • Major surgery involving chest, abdomen, or eyes within the past 3 months
  • Intrathoracic metallic foreign bodies or implants interfering with imaging (e.g., pacemaker, defibrillator, metallic prosthetic valves, shrapnel)
  • Allergy to any component of the Chinese herbal formula used in the study
  • Allergy to any component of ICS+LABA+LAMA therapy or inhaler propellants/excipients
  • Unable to accept or wear wearable devices
  • Pregnant or breastfeeding women
  • Long-term bedridden status, unable to perform daily activities, or life expectancy less than 1 year
  • Dementia or cognitive impairment preventing consent and follow-up
  • Living far from study center or planning to move within 3 years making follow-up impossible
  • Current participation in another interventional clinical trial involving the respiratory system
  • Refusal to provide written informed consent

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Hebi Coal Industry Group General Hospital

Hebi, Henan, China

Actively Recruiting

2

Tongliao Second People's Hospital

Tongliao, Neimeng, China

Actively Recruiting

3

Mianyang Third People's Hospital

Mianyang, Sichuan, China

Actively Recruiting

4

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, China

Actively Recruiting

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Research Team

Z

Zujin Luo, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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