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CompletedNCT04963244Updated Sep 5, 2021

Biomarker of Acute Exacerbation of COPD

An observational study in COPD Exacerbation, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
92
Ages
40 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • COPD Exacerbation

Keywords

  • chronic obstructive pulmonary disease
  • acute exacerbation
  • transcriptomic
  • pathogenesis
  • biomarkers
03

In context

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

For stable COPD:

Inclusion Criteria:

  1. Over 40 years old.
  2. in line with the diagnostic criteria in GOLD 2018.
  3. with the ability to sign informed consent.
  4. can be followed up according to the study protocol.

Exclusion Criteria:

  1. with other pulmonary diseases (such as lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis, cystic fibrosis) and severe α1-antitrypsin deficiency.
  2. with other inflammatory diseases (such as rheumatoid arthritis and inflammatory bowel disease, etc.).
  3. a history of pulmonary surgery, or a diagnosis of malignant tumor recently.
  4. a history of blood transfusion in 4 weeks.
  5. participating in a double-blind drug clinical trial.
  6. unable to walk.
  7. using oral or intravenous steroid therapy.
  8. with acute exacerbation in 4 weeks.

For AECOPD:

Inclusion Criteria:

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.

Exclusion Criteria:

  1. Other specific diseases that may account for sudden changes in respiratory symptoms should be excluded by clinical or laboratory tests.
  2. The remaining exclusion criteria were consistent with the above five criteria in stable COPD.

The control group:

Inclusion Criteria:

Healthy people over 40 years old.

Exclusion Criteria:

with chronic airway diseases and other lung diseases, and heart, kidney, liver, and other important organ diseases.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
92 participants (actual)
Patient registry
No

Groups and cohorts

  • AECOPD
  • Stable COPD
  • Control
06

What researchers measure

Primary outcomes

  1. Differentially expressed genes of 13 participants as assessed by RNA sequencing

    Time frame: through study completion, an average of 1 year

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Study locations

1 site
  • the Second Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04963244
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Sponsor
First posted
Jul 15, 2021
Start date
Apr 1, 2018
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021
Last update
Sep 5, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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