COPDNCT06724848
A Translational Study for Prediction of Biomarkers and Identification of Phenotype and Endotype of COPD and Pre-COPD Outcomes in Chinese Population
An observational study of COPD, run by AstraZeneca at 14 sites in China.
Trial summary
This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on pre-COPD or PRISm, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants for 1-year period. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD
- How many people
- 850 participants
- Where
- 14 sitesChina
- Study dates
- 5 Jun 2024to 21 Oct 2027
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a multi-center, longitudinal, observational study which includes COPD group with external healthy controls. External healthy controls will be selected from the healthy volunteers enrolled in the asthma translational study (D2287R00186, sponsored by AstraZeneca), whose characteristics match as the entry criteria for Cohort A in the study. Other than participating the procedures of asthma translational study with additional specific activities for COPD, no other activities will be performed in this COPD translational study for Cohort A.
Who may be able to join
- Capable of giving signed ICF
- Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society and European Respiratory Society 2019 acceptability criteria.
- Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center.
- Participants will be allowed to enroll into other non-intervention studies while taking part in this study.
Who cannot join
- The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation.
- The participant has an altered mental status at the time of informed consent.
- Clinically significant abnormal laboratory values available vital signs, ECG, or laboratory testing at the screening assessment that, which in the opinion of the investigator, could interfere with the objectives of the study or safety of the participant. -Current diagnosis of asthma.
- Clinically important pulmonary disease.
- COPD exacerbation, within 2 weeks prior to enrollment or during screening period.
- History of partial or total lung resection (single lobe or segmentectomy is acceptable). Surgical or endoscopic (eg, valves) lung volume reduction within the 6 months prior to enrollment. Expected need for lung volume reduction surgery during the study.
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- Unstable disorders.
- Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrollment. Suspected malignancy or undefined neoplasms.
- Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation.
- Participants receipt marketed or investigational biologics biologics within 3 months or 5 half-lives prior to visit 1, whichever is longer.
- Female participants who are pregnant.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Research Site
Beijing
- Recruiting
Research Site
Changsha
- Recruiting
Research Site
Chengdu
- Recruiting
Research Site
Guangzhou
- Recruiting
Research Site
Hefei
- Recruiting
Research Site
Nanjing
- Recruiting
Research Site
Nanning
- Recruiting
Research Site
Shanghai
- Not yet recruiting
Research Site
Shanghai
- Not yet recruiting
Research Site
Shenyang
- Recruiting
Research Site
Shenyang
- Recruiting
Research Site
Wuhan
- Recruiting
Research Site
Xuzhou
- Recruiting
Research Site
Zhengzhou
About this study
Official title: A Translational Study in Patients With COPD and Pre-COPD to Describe Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population
This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on pre-COPD or PRISm, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants for 1-year period.
- Conditions
- COPD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Healthy controls from asthma translational study: approximately 50 healthy participants aged 30 or older. | |
| Cohort B | pre-COPD or PRISm: approximately 110 participants at 30 to 50 years of age (inclusive) with respiratory symptoms and/or structural lung lesions and/or physiological abnormalities without airflow obstruction (FEV1/FVC >= 0.7 post-bronchodilation). PRISm is defined as preserved ratio (FEV1/FVC >= 0.7 post-bronchodilation) with impaired spirometry (FEV1 < 80% of reference post-bronchodilation). | |
| Cohort C1 | Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C1: participants at 30 to 50 years of age (inclusive). | |
| Cohort C2 | Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C2: participants elder than 50 years of age (exclusive) within Cohort C mild COPD (approximately 110 total across C1 and C2). | |
| Corhort D | Moderate to very severe COPD: approximately 330 COPD participants (males and females aged 50 years or older) with moderate to very severe airflow limitation defined as post-bronchodilation FEV1/FVC < 70% and FEV1 >= 25% and < 80% of predicted, and presence of respiratory symptoms equivalent to CAT >= 10 or mMRC >= 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical History
Risk factors of COPD development or lung function decline
Measured: At Baseline
Occupation
Risk factors of COPD development or lung function decline
Measured: At Baseline
Birth Status
Risk factors of COPD development or lung function decline
Measured: At Baseline
Place of residence
Risk factors of COPD development or lung function decline
Measured: At Baseline
Smoking history and status
Risk factors of COPD development or lung function decline
Measured: At Baseline to week 56
Family history
Risk factors of COPD development or lung function decline
Measured: At Baseline
Exacerbation/respiratory history and event
Measurement of disease control and burden
Measured: At Baseline to week 56
COPD related HRU
Risk factors of COPD development or lung function decline
Measured: At Baseline to week 56
SGRQ
Measurement of questionnaires
Measured: At Baseline to week 56
CAT
Measurement of questionnaires
Measured: At Baseline to week 56
MARS-5 (only applicable for COPD cohort)
Measurement of questionnaires
Measured: At Baseline to week 56
Variables in COPD related medication, changes in medication
Measurement of treatment pattern
Measured: At Baseline to week 56
FEV1 %
Measurement of lung function
Measured: At Baseline to week 56
FEV1 /FVC
Measurement of lung function
Measured: At Baseline to week 56
Forced Osc
Measurement of lung function
Measured: At Baseline to week 56
FEF25-75
Measurement of lung function
Measured: At Baseline to week 56
DLCO
Measurement of lung function
Measured: At Baseline to week 56
LAAinsp-950%
Measurement of lung structure profile and change through radiological parameters (CT scan)
Measured: At Baseline to week 56
LAAexp-856%
Measurement of lung structure profile and change through radiological parameters (CT scan)
Measured: At Baseline to week 56
WA%
Measurement of lung structure profile and change through radiological parameters (CT scan)
Measured: At Baseline to week 56
Inflammatory differentials and counts in blood and BALF
Measurement of inflammatory cell locally and systemically
Measured: At Baseline to week 56
Inflammatory cell infiltration
Measurement of inflammatory cell locally and systemically
Measured: At Baseline to week 56
MUC5B/MUC5AC
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Measured: At Baseline to week 56
IL-33/ST2 complex
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Measured: At Baseline to week 56
IL-33
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Measured: At Baseline to week 56
Air trapping index
Measurement of lung structure profile and change through radiological parameters (CT scan)
Measured: At Baseline to week 56
hsCRP
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Measured: At baseline to week 56
Transcriptomic test in nasal, bronchial brushings, biopsies and BALF asmples
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Measured: At baseline to week 56
Proteomic test in blood, sputum, BALF and NLF samples
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Measured: At baseline to week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start5 Jun 2024
- Primary completion21 Oct 2027 (estimated)
- Study completion21 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724848
- Sponsor's protocol ID
- D2287R00187
- Status last verified
- May 2026
- First submitted
- 8 May 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Study in Patients With COPD and Pre-COPD to Describe Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population
- ClinicalTrials.gov ID
- NCT06724848
- Acronym / sponsor ID
- D2287R00187
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 21 Oct 2027 (estimated)
- Study completion
- 21 Oct 2027 (estimated)
- First posted
- 9 Dec 2024 (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.
This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on pre-COPD or PRISm, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants for 1-year period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –Healthy controls from asthma translational study: approximately 50 healthy participants aged 30 or older. |
| Cohort B | – | –pre-COPD or PRISm: approximately 110 participants at 30 to 50 years of age (inclusive) with respiratory symptoms and/or structural lung lesions and/or physiological abnormalities without airflow obstruction (FEV1/FVC >= 0.7 post-bronchodilation). PRISm is defined as preserved ratio (FEV1/FVC >= 0.7 post-bronchodilation) with impaired spirometry (FEV1 < 80% of reference post-bronchodilation). |
| Cohort C1 | – | –Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C1: participants at 30 to 50 years of age (inclusive). |
| Cohort C2 | – | –Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C2: participants elder than 50 years of age (exclusive) within Cohort C mild COPD (approximately 110 total across C1 and C2). |
| Corhort D | – | –Moderate to very severe COPD: approximately 330 COPD participants (males and females aged 50 years or older) with moderate to very severe airflow limitation defined as post-bronchodilation FEV1/FVC < 70% and FEV1 >= 25% and < 80% of predicted, and presence of respiratory symptoms equivalent to CAT >= 10 or mMRC >= 2. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multi-center, longitudinal, observational study which includes COPD group with external healthy controls. External healthy controls will be selected from the healthy volunteers enrolled in the asthma translational study (D2287R00186, sponsored by AstraZeneca), whose characteristics match as the entry criteria for Cohort A in the study. Other than participating the procedures of asthma translational study with additional specific activities for COPD, no other activities will be performed in this COPD translational study for Cohort A.
Key inclusion criteria (4 listed)
- Capable of giving signed ICF
- Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society and European Respiratory Society 2019 acceptability criteria.
- Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center.
- Participants will be allowed to enroll into other non-intervention studies while taking part in this study.
Key exclusion criteria (11 listed)
- The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation.
- The participant has an altered mental status at the time of informed consent.
- Clinically significant abnormal laboratory values available vital signs, ECG, or laboratory testing at the screening assessment that, which in the opinion of the investigator, could interfere with the objectives of the study or safety of the participant. -Current diagnosis of asthma.
- Clinically important pulmonary disease.
- COPD exacerbation, within 2 weeks prior to enrollment or during screening period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medical History
Time frame: At Baseline
Risk factors of COPD development or lung function decline
Occupation
Time frame: At Baseline
Risk factors of COPD development or lung function decline
Birth Status
Time frame: At Baseline
Risk factors of COPD development or lung function decline
Place of residence
Time frame: At Baseline
Risk factors of COPD development or lung function decline
Smoking history and status
Time frame: At Baseline to week 56
Risk factors of COPD development or lung function decline
Family history
Time frame: At Baseline
Risk factors of COPD development or lung function decline
Exacerbation/respiratory history and event
Time frame: At Baseline to week 56
Measurement of disease control and burden
COPD related HRU
Time frame: At Baseline to week 56
Risk factors of COPD development or lung function decline
SGRQ
Time frame: At Baseline to week 56
Measurement of questionnaires
CAT
Time frame: At Baseline to week 56
Measurement of questionnaires
MARS-5 (only applicable for COPD cohort)
Time frame: At Baseline to week 56
Measurement of questionnaires
Variables in COPD related medication, changes in medication
Time frame: At Baseline to week 56
Measurement of treatment pattern
FEV1 %
Time frame: At Baseline to week 56
Measurement of lung function
FEV1 /FVC
Time frame: At Baseline to week 56
Measurement of lung function
Forced Osc
Time frame: At Baseline to week 56
Measurement of lung function
FEF25-75
Time frame: At Baseline to week 56
Measurement of lung function
DLCO
Time frame: At Baseline to week 56
Measurement of lung function
LAAinsp-950%
Time frame: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
LAAexp-856%
Time frame: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
WA%
Time frame: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
Inflammatory differentials and counts in blood and BALF
Time frame: At Baseline to week 56
Measurement of inflammatory cell locally and systemically
Inflammatory cell infiltration
Time frame: At Baseline to week 56
Measurement of inflammatory cell locally and systemically
MUC5B/MUC5AC
Time frame: At Baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
IL-33/ST2 complex
Time frame: At Baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
IL-33
Time frame: At Baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Air trapping index
Time frame: At Baseline to week 56
Measurement of lung structure profile and change through radiological parameters (CT scan)
hsCRP
Time frame: At baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Transcriptomic test in nasal, bronchial brushings, biopsies and BALF asmples
Time frame: At baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Proteomic test in blood, sputum, BALF and NLF samples
Time frame: At baseline to week 56
Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
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 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
AstraZeneca Clinical Study Information Center contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by AstraZeneca at 14 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 4 inclusion and 11 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical History (time frame: At Baseline). The study lists 29 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 2 Jun 2026.