Chronic Obstructive Pulmonary Disease (COPD)IMPACTNCT07382986
IMPACT COPD Cohort (China)
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Multimorbidities, run by Beijing Chao Yang Hospital at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Multimorbidities
- What is being tested?
- Not applicable- observational study
- How many people
- 10,000 participants
- Where
- 4 sitesChina
- Study dates
- 26 Feb 2026to 25 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Age 40-85 years;
- Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Hebi Coal Industry Group General Hospital
Hebi, Henan
Zhijun Li, MD, 13939283860, lizhijun28@163.com
- Recruiting
Mianyang Third People's Hospital
Mianyang, Sichuan
Juan Wang, MD, 15984625780, 739412332@qq.com
- Recruiting
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang
Chao Wu, MD, 18997983218, mail@wu95.com
- Recruiting
Tongliao Second People's Hospital
Tongliao, Neimeng
Ying Li, MD, 13848056771, 496808461@qq.com
About this study
Official title: Integrative Medicine Program for COPD With Comorbidity Management
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.
- Being tested
- Not applicable- observational study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
For this observational study, participants are not assigned an intervention as part of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual rate of COPD exacerbation
Measured: up to 36 months
Incidence of COPD-related comorbidities (hypertension, coronary artery disease, arrhythmia, heart failure, diabetes, etc.)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start26 Feb 2026
- Primary completion25 Feb 2030 (estimated)
- Study completion25 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382986
- Sponsor's protocol ID
- BeijingCYH-2025ZD0548902
- Other IDs
- 2025ZD0548902
- Acronym
- IMPACT
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Medicine Program for COPD With Comorbidity Management
- ClinicalTrials.gov ID
- NCT07382986
- Acronym / sponsor ID
- IMPACT / BeijingCYH-2025ZD0548902
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 25 Feb 2030 (estimated)
- Study completion
- 25 Feb 2030 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- Age 40-85 years;
- Diagnosis of chronic obstructive pulmonary disease (COPD) according to the 2025 GOLD criteria.
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyFor this observational study, participants are not assigned an intervention as part of the study. | Other | – |
Primary outcome
Annual rate of COPD exacerbation
Time frame: up to 36 months
Incidence of COPD-related comorbidities (hypertension, coronary artery disease, arrhythmia, heart failure, diabetes, etc.)
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Multimorbidities, run by Beijing Chao Yang Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zujin Luo, MD (+86-13810497587, xmjg2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual rate of COPD exacerbation (time frame: up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.