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临床试验/NCT02113839
NCT02113839已完成不适用

Breathlessness Perception in COPD: Relationship With Exacerbation Frequency

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
The negative airway pressure generated during the first 100 ms of an occluded inspiration, which is an estimation of the neuromuscular drive to breathe. (P01 )

研究概览

简要总结

The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.

Cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations or without frequent exacerbations.

To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method.

详细描述

The perception of breathlessness varies between individuals. This is a well-established concept in asthma, but mostly unexplored in COPD; the relationship between airflow limitation (FEV1, % ref.) and breathlessness (mMRC) is weak.

The perception of breathlessness varies significantly among COPD patients with similar severity of airflow limitation; those with poorer perception report less exacerbations as compared to those with frequent exacerbations.

It is a cross-sectional comparison of breathlessness perception in COPD patients with frequent exacerbations (≥2 or ≥1 with hospitalization in the previous year) or without frequent exacerbations (0 or 1 without hospitalization in the previous year).

To assess "Breathlessness Perception" the investigators will increase the ventilatory demand of the patients by CO2-rebreathing method. CO2 rebreathing test will be conducted to evaluate the acute ventilatory response to CO2 inhalation used to estimate central chemoreceptor responsiveness in patients with the obstructive pulmonary disease.

Simple descriptive statistics (unpaired T-test) and correlation analysis (bivariate and multivariate) will be used to analyze results.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with diagnosis of COPD (Gold 2 or 3 or 4)
  • >2 months from last exacerbation and no change in therapy

排除标准

  • patients on regular sedative drugs
  • patients with neuromuscular diseases
  • patients with respiratory failure and/or in long-term oxygen therapy

结局指标

主要结局

The negative airway pressure generated during the first 100 ms of an occluded inspiration, which is an estimation of the neuromuscular drive to breathe. (P01 )

时间窗: Baseline

次要结局

  • Fractional exhaled nitric oxide (FeNO)(Baseline)
  • Borg scale(Baseline)
  • CO exhaled test(Baseline)
  • Inspiratory capacity (IC)(Baseline)
  • Ventilation at rest(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabel Blanco

MD, PhD

Hospital Clinic of Barcelona

研究点 (2)

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