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OpenTrials
Completed

NCT Number: NCT04963244

Biomarker of Acute Exacerbation of COPD

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For stable COPD:

Inclusion criteria

  • 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.

Exclusion criteria

  • 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:

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

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

Treatment and study plan

Primary outcomes

  1. Differentially expressed genes of 13 participants as assessed by RNA sequencing

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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