Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yue Zhang; Phone Number: +86-21-25077373; Email: zhangyue01@xinhuamed.com.cn

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Department of Respiratory Medicine, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    • Contact: Yue Zhang; Phone Number: +86-21-25077373; Email: zhangyue01@xinhuamed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects aged >40 years,baseline post-bronchodilator FEV1 less than 80% of the reference value and FEV1/FVC of less than or equal to 0.7, when clinically stable or Exacerbation; current,ex-smokers or no smokers. Exclusion Criteria：Participants had COPD complicated by a comorbidity such as pneumothorax, pulmonary embolism, lung cancer, or left cardiac insufficiency. Other exclusion criteria included a diagnosis of asthma, extensive bronchiectasis, sequelae of tuberculosis, interstitial lung disease, or restrictive disease.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with acute exacerbations of chronic obstructive pulmonary disease	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.	one year

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2017
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: XH-17-019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No