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Abstract：
BACKGROUND: FOOTPRINTS® is a prospective, longitudinal, 3-year study assessing the association between biomarkers of inflammation/lung tissue destruction and chronic obstructive pulmonary disease (COPD) severity and progression in ex-smokers with mild-to-severe COPD. Here, we present baseline characteristics and select biomarkers of study subjects.
METHODS: The methodology of FOOTPRINTS® has been published previously. The study population included ex-smokers with a range of COPD severities (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages 1-3), ex-smokers with COPD and alpha-1-antitrypsin deficiency (A1ATD) and a control group of ex-smokers without airflow limitation (EwAL). At study entry, data were collected for: demographics, disease characteristics, history of comorbidities and COPD exacerbations, symptoms, lung function and volume, exercise capacity, soluble biomarkers, and quantitative and qualitative computed tomography. Baseline data are presented with descriptive statistical comparisons for soluble biomarkers in the individual GOLD and A1ATD groups versus EwAL.
RESULTS: In total, 463 subjects were enrolled. The per-protocol set comprised 456 subjects, mostly male (64.5%). The mean (standard deviation) age was 60.7 (6.9) years. At baseline, increasing pulmonary symptoms, worse lung function, increased residual volume, reduced diffusing capacity of the lung for carbon monoxide (DLco) and greater prevalence of centrilobular emphysema were observed with increasing disease severity amongst GOLD 1-3 subjects. Subjects with A1ATD (n = 19) had similar lung function parameters to GOLD 2-3 subjects, a high residual volume comparable to GOLD 3 subjects, and similar air trapping to GOLD 2 subjects. Compared with EwAL (n = 61), subjects with A1ATD had worse lung function, increased residual volume, reduced DLco, and a greater prevalence of confluent or advanced destructive emphysema. The soluble inflammatory biomarkers white blood cell count, fibrinogen, high-sensitivity C-reactive protein and plasma surfactant protein were higher in GOLD 1-3 groups than in the EwAL group. Interleukin-6 was expressed less often in EwAL subjects compared with subjects in the GOLD and A1ATD groups. Soluble receptor for advanced glycation end product was lowest in GOLD 3 subjects, indicative of more severe emphysema.
CONCLUSIONS: These findings provide context for upcoming results from FOOTPRINTS®, which aims to establish correlations between biomarkers and disease progression in a representative COPD population.
BACKGROUND: NCT02719184, study start date 13/04/2016.
METHODS: The methodology of FOOTPRINTS® has been published previously. The study population included ex-smokers with a range of COPD severities (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages 1-3), ex-smokers with COPD and alpha-1-antitrypsin deficiency (A1ATD) and a control group of ex-smokers without airflow limitation (EwAL). At study entry, data were collected for: demographics, disease characteristics, history of comorbidities and COPD exacerbations, symptoms, lung function and volume, exercise capacity, soluble biomarkers, and quantitative and qualitative computed tomography. Baseline data are presented with descriptive statistical comparisons for soluble biomarkers in the individual GOLD and A1ATD groups versus EwAL.
RESULTS: In total, 463 subjects were enrolled. The per-protocol set comprised 456 subjects, mostly male (64.5%). The mean (standard deviation) age was 60.7 (6.9) years. At baseline, increasing pulmonary symptoms, worse lung function, increased residual volume, reduced diffusing capacity of the lung for carbon monoxide (DLco) and greater prevalence of centrilobular emphysema were observed with increasing disease severity amongst GOLD 1-3 subjects. Subjects with A1ATD (n = 19) had similar lung function parameters to GOLD 2-3 subjects, a high residual volume comparable to GOLD 3 subjects, and similar air trapping to GOLD 2 subjects. Compared with EwAL (n = 61), subjects with A1ATD had worse lung function, increased residual volume, reduced DLco, and a greater prevalence of confluent or advanced destructive emphysema. The soluble inflammatory biomarkers white blood cell count, fibrinogen, high-sensitivity C-reactive protein and plasma surfactant protein were higher in GOLD 1-3 groups than in the EwAL group. Interleukin-6 was expressed less often in EwAL subjects compared with subjects in the GOLD and A1ATD groups. Soluble receptor for advanced glycation end product was lowest in GOLD 3 subjects, indicative of more severe emphysema.
CONCLUSIONS: These findings provide context for upcoming results from FOOTPRINTS®, which aims to establish correlations between biomarkers and disease progression in a representative COPD population.
BACKGROUND: NCT02719184, study start date 13/04/2016.
摘要：
背景：FOOTPRINTS®是一个有前景的，纵向,为期3年的研究评估了炎症/肺组织破坏的生物标志物与慢性阻塞性肺疾病（COPD）严重程度和进展之间的关系。这里,我们提供研究对象的基线特征并选择生物标志物.
方法：FOOTPRINTS®的方法先前已发表。研究人群包括患有一系列COPD严重程度（全球慢性阻塞性肺疾病倡议[GOLD]1-3期）的戒烟者，患有COPD和α-1-抗胰蛋白酶缺乏症（A1ATD）的戒烟者和无气流受限的戒烟者（EwAL）的对照组。在研究进入时，收集的数据是：人口统计学，疾病特征，合并症和COPD加重的病史，症状,肺功能和容量，锻炼能力,可溶性生物标志物，定量和定性计算机断层扫描。基线数据以单个GOLD和A1ATD组与EwAL组的可溶性生物标志物的描述性统计比较呈现。
结果：总计，纳入463名受试者。每个协议集包括456名受试者，大部分为男性（64.5%）。平均（标准差）年龄为60.7（6.9）岁。在基线,肺部症状加重,肺功能变差,剩余体积增加，在GOLD1-3受试者中,随着疾病严重程度的增加,观察到肺对一氧化碳(DLco)的扩散能力降低和小叶中心肺气肿的患病率增加.A1ATD患者（n=19）的肺功能参数与GOLD2-3患者相似，与GOLD3受试者相当的高剩余量，和类似的空气捕获金2科目。与EwAL(n=61)相比，A1ATD患者肺功能较差，剩余体积增加，减少DLco，融合性或晚期破坏性肺气肿的患病率更高。可溶性炎症生物标志物白细胞计数，纤维蛋白原，GOLD1-3组的高敏C反应蛋白和血浆表面活性蛋白高于EwAL组.与GOLD和A1ATD组的受试者相比，白细胞介素-6在EwAL受试者中的表达频率较低。晚期糖基化终产物的可溶性受体在GOLD3受试者中最低，指示更严重的肺气肿。
结论：这些发现为FOOTPRINTS®即将到来的结果提供了背景，旨在建立代表性COPD人群中生物标志物与疾病进展之间的相关性。
背景：NCT02719184，研究开始日期2016年4月13日。
方法：FOOTPRINTS®的方法先前已发表。研究人群包括患有一系列COPD严重程度（全球慢性阻塞性肺疾病倡议[GOLD]1-3期）的戒烟者，患有COPD和α-1-抗胰蛋白酶缺乏症（A1ATD）的戒烟者和无气流受限的戒烟者（EwAL）的对照组。在研究进入时，收集的数据是：人口统计学，疾病特征，合并症和COPD加重的病史，症状,肺功能和容量，锻炼能力,可溶性生物标志物，定量和定性计算机断层扫描。基线数据以单个GOLD和A1ATD组与EwAL组的可溶性生物标志物的描述性统计比较呈现。
结果：总计，纳入463名受试者。每个协议集包括456名受试者，大部分为男性（64.5%）。平均（标准差）年龄为60.7（6.9）岁。在基线,肺部症状加重,肺功能变差,剩余体积增加，在GOLD1-3受试者中,随着疾病严重程度的增加,观察到肺对一氧化碳(DLco)的扩散能力降低和小叶中心肺气肿的患病率增加.A1ATD患者（n=19）的肺功能参数与GOLD2-3患者相似，与GOLD3受试者相当的高剩余量，和类似的空气捕获金2科目。与EwAL(n=61)相比，A1ATD患者肺功能较差，剩余体积增加，减少DLco，融合性或晚期破坏性肺气肿的患病率更高。可溶性炎症生物标志物白细胞计数，纤维蛋白原，GOLD1-3组的高敏C反应蛋白和血浆表面活性蛋白高于EwAL组.与GOLD和A1ATD组的受试者相比，白细胞介素-6在EwAL受试者中的表达频率较低。晚期糖基化终产物的可溶性受体在GOLD3受试者中最低，指示更严重的肺气肿。
结论：这些发现为FOOTPRINTS®即将到来的结果提供了背景，旨在建立代表性COPD人群中生物标志物与疾病进展之间的相关性。
背景：NCT02719184，研究开始日期2016年4月13日。
