IMPACT COPD Cohort (China)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorBeijing Chao Yang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40-85 years;
Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria.
Disqualifiers
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;
Trial population
Participants will be recruited from multiple hospitals in China. Eligible participants are adults aged 40-85 years with COPD diagnosed according to the 2025 GOLD criteria, identified in outpatient clinics and/or inpatient settings and enrolled for prospective follow-up.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not applicable- observational study
Other interventionFor this observational study, participants are not assigned an intervention as part of the study.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Annual rate of COPD exacerbation
Time frame
up to 36 months2
Incidence of COPD-related comorbidities (hypertension, coronary artery disease, arrhythmia, heart failure, diabetes, etc.)
Time frame
up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov