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Clinical Trials/NCT03450603
NCT03450603
Recruiting
Not Applicable

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 site in 1 country200 target enrollmentDecember 10, 2017

Overview

Phase
Not Applicable
Intervention
stable COPD
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Enrollment
200
Locations
1
Primary Endpoint
Number of participants with acute exacerbations of chronic obstructive pulmonary disease
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2017
End Date
December 30, 2027
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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 months.

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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