Biomarker of Acute Exacerbation of COPD

COPD Exacerbation Clinical Trial

Official title:

Biomarker of Acute Exacerbation of COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963244
• Other study ID #: 2018-099
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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 a1-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.

Related Conditions & MeSH terms

• COPD Exacerbation

Locations

Country	Name	City	State
China	the Second Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differentially expressed genes of 13 participants as assessed by RNA sequencing		through study completion, an average of 1 year