Biomarker of Acute Exacerbation of COPD

NCT04963244 | Completed

• 1 other identifier: 2018-099
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

chronic obstructive pulmonary disease; acute exacerbation; transcriptomic; pathogenesis; biomarkers

Outcome Measures

Primary Outcomes (1)

• Differentially expressed genes of 13 participants as assessed by RNA sequencing

  through study completion, an average of 1 year

Study Arms (3)

AECOPD

Stable COPD

Control

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 control group:
• Healthy people over 40 years old.
• with chronic airway diseases and other lung diseases, and heart, kidney, liver, and other important organ diseases.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

the Second Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: July 15, 2021
• Study Start: April 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-06

Locations

CN (1)