Biomarker of Acute Exacerbation of COPD

NCT ID: NCT04963244

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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COPD Exacerbation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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AECOPD

Intervention Type OTHER

Stable COPD

Intervention Type OTHER

Control

Intervention Type OTHER

Interventions

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Intervention Type OTHER

Eligibility Criteria

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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.


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.

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:


1. Other specific diseases that may account for sudden changes in respiratory symptoms should be excluded by clinical or laboratory tests.

The control group:


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

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the Second Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2018-099

Identifier Type: -

Identifier Source: org_study_id

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