COPD ExacerbationNCT04963244
Biomarker of Acute Exacerbation of COPD
An observational study of COPD Exacerbation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the main factor that leads to the deterioration of the disease. Currently, the diagnosis of AECOPD mainly relies on clinical manifestations, and good predictors or biomarkers are lacking. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD Exacerbation
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with stable COPD and AECOPD and healthy controls were recruited from the Second Affiliated Hospital of Zhejiang University School of Medicine and Yuhang District of the Second Affiliated Hospital of Zhejiang University, Hangzhou, China.
Who may be able to join
- Over 40 years old.
- in line with the diagnostic criteria in GOLD 2018.
- with the ability to sign informed consent.
- can be followed up according to the study protocol.
- Patients who were over 40 years old were eligible for inclusion if they had a diagnosis of COPD in their primary care clinical record and were presenting with an acute exacerbation of respiratory symptoms.
- Healthy people over 40 years old.
Who cannot join
- with other pulmonary diseases (such as lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis, cystic fibrosis) and severe α1-antitrypsin deficiency.
- with other inflammatory diseases (such as rheumatoid arthritis and inflammatory bowel disease, etc.).
- a history of pulmonary surgery, or a diagnosis of malignant tumor recently.
- a history of blood transfusion in 4 weeks.
- participating in a double-blind drug clinical trial.
- unable to walk.
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- using oral or intravenous steroid therapy.
- with acute exacerbation in 4 weeks.
- For AECOPD:
- Other specific diseases that may account for sudden changes in respiratory symptoms should be excluded by clinical or laboratory tests.
- The remaining exclusion criteria were consistent with the above five criteria in stable COPD.
- The control group:
- with chronic airway diseases and other lung diseases, and heart, kidney, liver, and other important organ diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the main factor that leads to the deterioration of the disease. Currently, the diagnosis of AECOPD mainly relies on clinical manifestations, and good predictors or biomarkers are lacking. This study aims to explain the gene expression changes related to the disease at the transcriptional level and validate it in multiple levels, reveal specific biomarkers and potential pathogenesis, to provide a research basis for the diagnosis and treatment of AECOPD.
- Conditions
- COPD Exacerbation
- Keywords
- chronic obstructive pulmonary disease, acute exacerbation, transcriptomic, pathogenesis, biomarkers
- 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.
Other
| Study group | Role | What they receive |
|---|---|---|
| AECOPD | Not described | |
| Stable COPD | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentially expressed genes of 13 participants as assessed by RNA sequencing
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Apr 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963244
- Sponsor's protocol ID
- 2018-099
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker of Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT04963244
- Acronym / sponsor ID
- 2018-099
- Conditions
- COPD Exacerbation
- Keywords
- chronic obstructive pulmonary disease, acute exacerbation, transcriptomic, pathogenesis, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 15 Jul 2021 (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.
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the main factor that leads to the deterioration of the disease. Currently, the diagnosis of AECOPD mainly relies on clinical manifestations, and good predictors or biomarkers are lacking. This study aims to explain the gene expression changes related to the disease at the transcriptional level and validate it in multiple levels, reveal specific biomarkers and potential pathogenesis, to provide a research basis for the diagnosis and treatment of AECOPD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AECOPD | – | – |
| Stable COPD | – | – |
| Control | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable COPD and AECOPD and healthy controls were recruited from the Second Affiliated Hospital of Zhejiang University School of Medicine and Yuhang District of the Second Affiliated Hospital of Zhejiang University, Hangzhou, China.
Key inclusion criteria (6 listed)
- Over 40 years old.
- in line with the diagnostic criteria in GOLD 2018.
- with the ability to sign informed consent.
- can be followed up according to the study protocol.
- Patients who were over 40 years old were eligible for inclusion if they had a diagnosis of COPD in their primary care clinical record and were presenting with an acute exacerbation of respiratory symptoms.
Key exclusion criteria (13 listed)
- with other pulmonary diseases (such as lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis, cystic fibrosis) and severe α1-antitrypsin deficiency.
- with other inflammatory diseases (such as rheumatoid arthritis and inflammatory bowel disease, etc.).
- a history of pulmonary surgery, or a diagnosis of malignant tumor recently.
- a history of blood transfusion in 4 weeks.
- participating in a double-blind drug clinical trial.
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 |
|---|---|---|
| Other | AECOPD, Control, Stable COPD |
Primary outcome
Differentially expressed genes of 13 participants as assessed by RNA sequencing
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD Exacerbation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 5 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differentially expressed genes of 13 participants as assessed by RNA sequencing (time frame: through study completion, an average of 1 year). 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 5 Sep 2021.