Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.
Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Jieping Lei, Ph.D.
jiepinglei@126.com
+86 010 8420 6408
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 84
Treatments
Preserved ratio impaired spirometry (PRISm)
People with post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 0.70 and FEV1 and/or FVC \< 80% predicted, or FEV1/FVC ≥ lower limit of normal (LLN) and FEV1 \< LLN.
COPD Stage 0
People who had COPD-related risk factor exposure (e.g. cigarette smoke) and/or presented with respiratory symptoms (e.g. chronic cough, and/or sputum production) whereas with normal pulmonary function.
Pre-COPD
People (importantly, of any age) who had respiratory symptoms (e.g. cough, sputum production, dyspnea, and/or exacerbation) with or without detectable structural (e.g. thoracic computed tomography (CT) emphysema, small and/or large airway impairments) and/or functional (e.g. low diffusion capacity for carbon monoxide (DLCO), hyperinflation, small airway obstruction, and/or accelerated FEV1 decline) abnormalities, in the absence of airflow limitation, and who might (or not) develop persistent airflow limitation (i.e. COPD) over time.
Early COPD
People who were younger than 50 years with ten or more pack-years smoking history and any of these abnormalities: i) early airflow limitation (post-bronchodilator FEV1/FVC \< LLN), ii) compatible thoracic CT abnormalities, iii) rapid decline in FEV1 (\> 60 ml/year) that was accelerated relative to FVC.
Young COPD
COPD patients with post-bronchodilator FEV1/FVC \< 0.70 diagnosed in the 20-50 year age range.
Mild COPD
COPD patients with post-bronchodilator FEV1/FVC \< 0.70 and FEV1 ≥ 80% predicted.
Controls
People who were not belonged to any of above six early COPD status, and with pre- and post-bronchodilator FEV1/FVC ≥ 0·70, and with post-bronchodilator FEV1/FVC ≥ LLN.
Related Therapeutic Areas
Sponsors
Leads: China-Japan Friendship Hospital