Clinical trial NCT04963244: Biomarker of Acute Exacerbation of COPD
Official title: Biomarker of Acute Exacerbation of COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Exacerbation
Keywords: chronic obstructive pulmonary disease
acute exacerbation
transcriptomic
pathogenesis
biomarkers
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2021-07-15
Enrollment: 92
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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 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.

Primary outcomes:
measure: Differentially expressed genes of 13 participants as assessed by RNA sequencing
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: