此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?

2026年9月3日 更新者：Fundación para la Investigación del Hospital Clínico de Valencia

GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD Screening?

This is a multicenter observational prospective study in smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years / pack) with respiratory symptoms and presenting a normal spirometry.

The patients who sign the corresponding informed consent, will undergo a DLCO and will be divided into two groups according to the result:

  • Group I. Patients with DLCO <80%.
  • Group II Patients with DLCO≥80%.

Both groups will be followed for 5 years.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

236

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
    • Valencia
      • Valencia、Valencia、西班牙、46010
        • Hospital Clínico Universitario de Valencia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

不

取样方法

概率样本

研究人群

Subjects over 18 smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years /pack) with respiratory symptoms presenting normal spirometry

描述

Inclusion Criteria:

  • Age ≥18 years. The participant or his / her legal representative is willing and able to give informed consent to participate in the study.
  • Female or male patients with age equal to or greater than 18 years.
  • Smokers or ex-smokers with cumulative exposure ≥ 10 a / p
  • Respiratory symptoms
  • Normal spirometry.

Exclusion Criteria:

  • Age under 18 years.
  • Participation in another clinical study.
  • Patients with a life expectancy of less than 2 years due to neoplasms or other serious systemic diseases.
  • Refusal to sing informed consent.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Group I. Patients with DLCO <80%.
Patients with DLCO <80% will be followed at baseline and once a year during the study
其他：Standard Care plus oxidative stress study plus inflammation biomarkers study
Patients will followed during 5 years, Annual follo-up visits will be carried out during this period
Group II. Patients with DLCO ≥ 80%.
Patients with DLCO ≥80% only will be followed at baseline and year 5.
其他：Standard Care
Patients will followed during 5 years, and only 2 visits , baseline and 5 years

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Changes from baseline of Diffusion Capacity (DLCO) at 5 years
大体时间：through study completion, an average of 5 years
To determine the value of DLCO in COPD screening in smokers and ex-smokers with respiratory symptoms and normal spirometry (GOLD 0)
through study completion, an average of 5 years

次要结果测量

结果测量
措施说明
大体时间
Risk factors associated to the development of COPD
大体时间：through study completion, an average of 5 years
Risk factors associated to the development of COPD
through study completion, an average of 5 years
Changes from baseline of inflammatory Markers at 2 and 5 years
大体时间：2 and 5 years
To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages.
2 and 5 years
Oxidative stress
大体时间：through study completion, an average of 5 years
To Study of oxidative stress parameters in early disease stages
through study completion, an average of 5 years
Diffusion study
大体时间：through study completion, an average of 5 years
To Characterize patients in stage 0 of GOLD with impaired diffusion
through study completion, an average of 5 years
Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years
大体时间：Baseline and 5 years
To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories
Baseline and 5 years
Airflow limitation Study
大体时间：through study completion, an average of 5 years
To Investigate the contribution of measuring lung volumes for the diagnosis of COPD when there is no evidence of airflow limitation in spirometry (GOLD 0).
through study completion, an average of 5 years
Gender differences in value of diffusion (DLCO)
大体时间：through study completion, an average of 5 years
To assess if there are differences between men and women with diffusion disorder
through study completion, an average of 5 years
Childhood background
大体时间：Baseline
To assess whether factors, such as the effect of lung development during childhood and adolescence, bronchial hyperreactivity and / or the role of infections influences the risk of developing the disease or its progression.
Baseline
Comorbidity
大体时间：through study completion, an average of 5 years
To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.
through study completion, an average of 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fundación para la Investigación del Hospital Clínico de Valencia

调查人员

  • 研究主任：Cruz González, PhD、Hospital Clínico Universitario de Valencia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月10日

初级完成 (实际的)

2025年2月10日

研究完成 (实际的)

2025年12月31日

研究注册日期

首次提交

2021年7月26日

首先提交符合 QC 标准的

2021年8月16日

首次发布 (实际的)

2021年8月23日

研究记录更新

最后更新发布 (实际的)

2026年9月4日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GOLD 0-DLCO 1

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅