Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease

Overview

Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the course of disease for most COPD patients. Published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL), disease progression, mortality, health care utilisation and costs. However, the severity,evolution and outcome of an exacerbation may differ significantly between patients – some patients will recover completely in a short period of time while others may die. The identification of risk factors for an adverse outcome could help in distinguishing patients who require more intense management in order to prevent failures, achieve satisfactory recovery and reduce the negative clinical and socioeconomic impact of exacerbations.The pathogenesis of COPD is still unclear, so there is no specific treatment at present .COPD was considered to be the result of a combination of environmental and genetic factors. Genetic factors play an important role in the acute exacerbation of COPD.Therefore, it is an urgent need to explore the heterogeneity of COPD phenotype from the perspective of genes and to seek individualized prevention and treatment programs.This study is intended to provide a theoretical basis for the prevention, evaluation and development of individualized treatment plans for acute exacerbation of COPD, thereby improving the prognosis of the disease.

Full Title of Study: “It is Crucial to Identify Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease in Order to Provide Adequate Intensive Therapy and Closer Follow-up”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2019

Arms, Groups and Cohorts

  • stable COPD
    • Chronic obstructive pulmonary disease (COPD) was confirmed if the patient had a baseline post-bronchodilator FEV1 less than 80% of the reference value and forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) quotient of less than 70%.Select patients with COPD without acute attack within three monthsļ¼ˇ
  • exacerbation of COPD
    • Exacerbation was defined as an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough, and/or sputum that was beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with acute exacerbations of chronic obstructive pulmonary disease
    • Time Frame: one year
    • Acute exacerbations of chronic obstructive pulmonary disease is defined as an event in the natural course of the disease characterized by a change in the patient’s baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD.

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of Chronic obstructive pulmonary disease
  • aged >= 40 years

Exclusion Criteria

  • spirometry can not be completed because of various reasons
  • asthma
  • pulmonary embolism
  • lung cancer
  • sequelae of tuberculosis
  • extensive bronchiectasis
  • interstitial lung disease
  • left cardiac insufficiency

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Yue Zhang, +86-21-25077373, zhangyue01@xinhuamed.com.cn

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