NCT04853225已完成不适用
Investigation of the Clinical, Radiological and Biological Factors Associated With Disease Progression, Phenotypes and Endotypes of COPD in China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,005
- 试验地点
- 1
- 主要终点
- Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30
研究概览
简要总结
This is a non-drug interventional cohort study, which aims to investigate the clinical, radiological and biological factors associated with disease progression in COPD in China. Participants will be recruited from multiple hospitals across Guangdong province categorized as Type A hospitals (those at prefecture-level and above) and Type B hospitals (those below prefecture-level).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30
时间窗: Baseline (Day 1 of Month 1) and at Month 30
FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FEV1 was assessed and summarized. Also, yearly rate of change in FEV1 (pre- and post-bronchodilator) was analyzed using random coefficients models.
Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30
时间窗: Baseline (Day 1 of Month 1) and at Month 30
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FVC was assessed and summarized. Also, yearly rate of change in FVC (pre- and post-bronchodilator) was analyzed using random coefficients models.
次要结局
- Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30(Baseline (Day 1 of Month 1) and at Month 30)
- Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6(Baseline (Day 1 of Month 1) and Months 1 to 6)
- Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24(Baseline (Day 1 of Month 1) and Months 18 to 24)
- Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6(Months 1 to 6)
- Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts(Up to 30 months)
- Main Cohort: Absolute Values of CAT Score at Month 30(At Month 30)
- Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline(At Baseline (Day 1 of Month 1))
- Main Cohort: Total Score of CAPTURE at Month 18(At Month 18)
- Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6(Baseline (Day 1 of Month 1) to Month 6)
- Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18(Months 6 to 18)
- Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30(Months 18 to 30)
- Main Cohort: Number of Participants Who Died(Up to 30 months)
- Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24(Months 18 to 24)
- Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7)(At Baseline (Days 1 to 7 at Month 1))
- Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1)(Up to 30 days from study Day 8)
- Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19)(Up to 30 days from Month 18 (Months 18 to 19))
- Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline(At Baseline (Day 1 of Month 1))
- Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30(At Month 30)
- Main Cohort: Absolute Values of C-Reactive Protein at Baseline(At Baseline (Day 1 of Month 1))
- Main Cohort: Absolute Values of C-Reactive Protein at Month 30(At Month 30)
- Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline(At Baseline (Day 1 of Month 1))
- Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30(At Month 30)
- Main Cohort: Absolute Values of Hemoglobin at Baseline(At Baseline (Day 1 of Month 1))
- Main Cohort: Absolute Values of Hemoglobin at Months 30(At Month 30)
- Sub-cohort: Absolute Values of Serum Interferon-gamma-inducible Protein -10 (IP-10) and Serum Soluble Receptor for Advanced Glycation End Products (sRAGE) at Baseline(At Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30(At Month 30)
- Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline(At Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of CC16 at Month 30(At Month 30)
- Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline(At Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of HbA1c at Month 30(At Month 30)
- Sub-cohort: Sputum Microbiome as Assessed by Molecular Methods(Up to 30 months)
- Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline(At Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30(At Month 30)
- Main Cohort: Number of Participants With COPD Medication(Up to 30 months)
- Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern(Baseline (Day 1 of Month 1) and Month 30)
- Number of Participants With COPD Related Outpatient Visits(Up to 30 months)
- Number of Participants With Non-COPD Related Outpatient Visits(Up to 30 months)
- Number of Participants With COPD Related Emergency Visits(Up to 30 months)
- Number of Participants With Non-COPD Related Emergency Visits(Up to 30 months)
- Number of Participants With COPD Related Hospitalizations Visits(Up to 30 months)
- Number of Participants With Non-COPD Related Hospitalizations Visits(Up to 30 months)
- Direct Medical Costs Associated With COPD Medications During Study Period(Up to 30 months)
- Sub-cohort: Absolute Values of Airway Wall Area at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of Airway Wall Area at Month 30(At Month 30)
- Sub-cohort: Average of Airway Major Inner Diameter at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Average of Airway Major Inner Diameter at Month 30(At Month 30)
- Sub-cohort: Average of Airway Minor Inner Diameter at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Average of Airway Minor Inner Diameter at Month 30(At Month 30)
- Sub-cohort: Total Airway Count at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Total Airway Count at Month 30(At Month 30)
- Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of Pi10 at Month 30(At Month 30)
- Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Perc15 in Residual Volume at Month 30(At Month 30)
- Sub-cohort: Perc15 in Total Lung Capacity at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Perc15 in Total Lung Capacity at Month 30(At Month 30)
- Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of LAA-950 at Month 30(At Month 30)
- Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30(At Month 30)
- Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30(At Month 30)
- Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30(At Month 30)
- Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline(Baseline (Day 1 of Month 1))
- Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30(At Month 30)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)GastroEsophageal CancerNCT05644431Centre Leon Berard50
已完成
不适用
Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund DatabaseChronic Myeloid LeukaemiaNCT05286528Pfizer1,484
已完成
不适用
MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National RegistryMyelodysplastic SyndromeNCT01347944Celgene149
已完成
不适用
One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With MacroadenomaAcromegalyNCT01471405Ipsen54
已完成
不适用
Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)MPN (Myeloproliferative Neoplasms)NCT02953704Incyte Corporation1,469