Pulmonary Disease, Chronic ObstructiveNCT03240315
Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This is a 3-year longitudinal study designed to establish a personalized prediction and prevention system for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- Type of treatment
- Injection or infusion
- How many people
- 442 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD subjects in China
Who may be able to join
- Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.
- A signed and dated written informed consent is obtained prior to participation.
- Able to comply with the requirements of the protocol and be available for study visits over 3 years.
Who cannot join
- A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
- Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus)
- Known to be severely alpha-1-antitrypsin deficient
- Has experienced a moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks
- Having undergone lung surgery (e.g. lung reduction, lung transplant)
Show all 11Show fewer
- Have cancer or have had cancer in the 5 years prior to study entry
- Having received a blood transfusion in the 4 weeks prior to study start
- Inability to walk
- Taking part in a blinded drug study
- Having therapy with systemic corticosteroids at inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Establishment of Individualized Prediction System for Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Cloud Platform
This is a 3-year longitudinal study designed to establish a personalized prediction and prevention system for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Data will be prospectively collected from patients with chronic obstructive pulmonary disease (COPD) and healthy control participants, including clinical characteristics, pathophysiological parameters, etiological factors, and immunological information. These data will be analyzed using data mining approaches combined with Internet-based technologies.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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 |
|---|---|---|
| COPD subjects | Subjects with GOLD stage I-IV COPD | |
| Healthy control subjects | Ages 40 to 90, with no history of lung disease and no history of acute illness or medication use within the past month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of prediction platform for COPD exacerbation
The patients with chronic obstruction pulmonary disease will be followed up at intervals of 3 months for 3 years by the Modified British Medical Research Council (mMRC) score scale,spirometric analysis, sputum smear,questionnaire and so on. An exacerbation of COPD was diagnosed according to GOLD guidelines. Time to the first acute exacerbation and average number of acute exacerbations per year in COPD subjects will be record.Research of AECOPD Risk factors based on complex network analysis.Identification and validation of COPD exacerbations risk stratification and predictive markers based on data mining.
Measured: 3 years
Secondary outcomes (3)
Developing new protein chips for AECOPD
Systemic and airway autoantibody profiles and cytokine profiles will be measured using commercial multiplex bead-based assay to screen out a set of ideal AECOPD-related markers.
Measured: 3 years
Detection of immune repertoire in COPD/AECOPD
Immune status of COPD patients will be investigated by using the immune repertoire technique and its relationship with the pathophysiology of AECOPD will be identified.
Measured: 3 years
Pathogenic microorganism and drug resistance monitoring for COPD exacerbation
Dynamics of pathogenic microorganism and drug resistance in natural course of COPD will be investigated by using the metagenome technique and the culture technique.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Aug 2016
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Science and Technology Innovation Commission,China
- Responsible party
- Principal investigator, Fengyan Wang, Guangzhou Institute of Respiratory Disease
- Investigators
- Rongchang Chen, MD/Ph.D, Study director, Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240315
- Sponsor's protocol ID
- 201604020012
- Other IDs
- 2017YFC1310600
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2017
- Last updated
- 12 Jan 2026
- Results posted
- No
- Individual data sharing
- No
Publications
He W, Li X, Huang H, Tang Z, Zhu J, Yang Y, Chen Z, Miao C, Yang H, Zha S, Zhou Z, Liu J, Liang Z, Chen R, Wang F. The relevance of sputum galectin-7 levels to clinical and prognostic factors in patients with chronic obstructive pulmonary disease: a prospective cohort study from China. BMC Pulm Med. 2026 Feb 27;26(1):156. doi: 10.1186/s12890-026-04171-9.
PubMed 41761148Li X, Feng S, Yang Y, Liang Z, Song A, Chen J, Guo Z, Chen Z, Miao C, Yang H, He W, Zhou Z, Drummond MB, Chen R, Wang F. Association Between Airway Mucus Plugs and Risk of Moderate-to-Severe Exacerbations in Patients With COPD: Results From a Chinese Prospective Cohort Study. Chest. 2025 Sep;168(3):627-638. doi: 10.1016/j.chest.2025.03.026. Epub 2025 Apr 8.
PubMed 40210091Cass SP, Yang Y, Xiao J, McGrath JJC, Fantauzzi MF, Thayaparan D, Wang F, Liang Z, Long F, Stevenson CS, Chen R, Stampfli MR. Current smoking status is associated with reduced sputum immunoglobulin M and G expression in COPD. Eur Respir J. 2021 Feb 4;57(2):1902338. doi: 10.1183/13993003.02338-2019. Print 2021 Feb. No abstract available.
PubMed 32883677
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Individualized Prediction System for Acute Exacerbation of Chronic Obstructive Pulmonary Disease Based on Cloud Platform
- ClinicalTrials.gov ID
- NCT03240315
- Acronym / sponsor ID
- 201604020012
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Science and Technology Innovation Commission,China
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Aug 2017 (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 a 3-year longitudinal study designed to establish a personalized prediction and prevention system for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Data will be prospectively collected from patients with chronic obstructive pulmonary disease (COPD) and healthy control participants, including clinical characteristics, pathophysiological parameters, etiological factors, and immunological information. These data will be analyzed using data mining approaches combined with Internet-based technologies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD subjects | – | –Subjects with GOLD stage I-IV COPD |
| Healthy control subjects | – | –Ages 40 to 90, with no history of lung disease and no history of acute illness or medication use within the past month. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD subjects in China
Key inclusion criteria (3 listed)
- Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.
Key exclusion criteria (11 listed)
- A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
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
Establishment of prediction platform for COPD exacerbation
Time frame: 3 years
The patients with chronic obstruction pulmonary disease will be followed up at intervals of 3 months for 3 years by the Modified British Medical Research Council (mMRC) score scale,spirometric analysis, sputum smear,questionnaire and so on. An exacerbation of COPD was diagnosed according to GOLD guidelines. Time to the first acute exacerbation and average number of acute exacerbations per year in COPD subjects will be record.Research of AECOPD Risk factors based on complex network analysis.Identification and validation of COPD exacerbations risk stratification and predictive markers based on data mining.
3 secondary outcomes
Developing new protein chips for AECOPD
Time frame: 3 years
Detection of immune repertoire in COPD/AECOPD
Time frame: 3 years
Pathogenic microorganism and drug resistance monitoring for COPD exacerbation
Time frame: 3 years
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 12 Jan 2026.
- Derived from this study: PubMed 41761148He W, Li X, Huang H, Tang Z, Zhu J, Yang Y, Chen Z, Miao C, Yang H, Zha S, Zhou Z, Liu J, Liang Z, Chen R, Wang F. The relevance of sputum galectin-7 levels to clinical and prognostic factors in patients with chronic obstructive pulmonary disease: a prospective cohort study from China. BMC Pulm Med. 2026 Feb 27;26(1):156. doi: 10.1186/s12890-026-04171-9.
- Derived from this study: PubMed 40210091Li X, Feng S, Yang Y, Liang Z, Song A, Chen J, Guo Z, Chen Z, Miao C, Yang H, He W, Zhou Z, Drummond MB, Chen R, Wang F. Association Between Airway Mucus Plugs and Risk of Moderate-to-Severe Exacerbations in Patients With COPD: Results From a Chinese Prospective Cohort Study. Chest. 2025 Sep;168(3):627-638. doi: 10.1016/j.chest.2025.03.026. Epub 2025 Apr 8.
- Derived from this study: PubMed 32883677Cass SP, Yang Y, Xiao J, McGrath JJC, Fantauzzi MF, Thayaparan D, Wang F, Liang Z, Long F, Stevenson CS, Chen R, Stampfli MR. Current smoking status is associated with reduced sputum immunoglobulin M and G expression in COPD. Eur Respir J. 2021 Feb 4;57(2):1902338. doi: 10.1183/13993003.02338-2019. Print 2021 Feb. No abstract available.
- 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. This study is not recruiting at the moment.
Rongchang Chen, MD/Ph.D study director
Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Guangzhou Institute of Respiratory Disease at 1 site 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 3 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of prediction platform for COPD exacerbation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03240315, which also lists 3 linked publications.
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 12 Jan 2026.