Biomarker of Acute Exacerbation of COPD

Completed

• Conditions: COPD Exacerbation

• Registration Number: NCT04963244
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2021-06
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-15
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differentially expressed genes of 13 participants as assessed by RNA sequencing	through study completion, an average of 1 year

Trial Locations

Locations (1)

the Second Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China