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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04963244
Other study ID # 2018-099
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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