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临床试验/NCT02579772
NCT02579772已完成4 期

Systemic Vascular Dysfunction in COPD Patients With Mild-to-moderate Airflow Obstruction: Pharmacological Treatment With N-acetylcysteine

Queen's University0 个研究点目标入组 13 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
13
主要终点
Plasma Redox Status - Circulating Glutathione

研究概览

简要总结

The main purpose of this study is to determine whether pharmacological treatment with N-acetylcysteine improves central and peripheral cardiorespiratory control and physical capacity in COPD patients with mild-to-moderate airflow obstruction.

详细描述

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Cardiovascular complications constitute the main causes of poor physical capacity and healthcare resources utilization in COPD. There is emerging evidence that these impairments have a major impact on the health of patients with mild-to-moderate disease, the largest sub-population of COPD. This important problem, however, is currently neglected as no specific pharmacological treatment is offered to these patients. Recent studies indicate that vascular abnormalities are mediated, at least in part, by circulating inflammatory substances and direct damage of the arteries by oxygen radicals (oxidative stress). The current investigation will test the hypothesis that N-acetylcysteine (NAC), via its anti-inflammatory and antioxidant properties, improves systemic vascular function and physical capacity in COPD patients with mild-to-moderate airflow obstruction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • stable COPD with mild-to-moderate airflow obstruction as indicated by the low ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC<0.7) together with post-bronchodilator FEV1≥60% predicted under optimized clinical treatment as judged by the accompanying physician

排除标准

  • unable to perform all experimental procedures and/or provide informed consent;
  • hospital admission in the previous 6 weeks;
  • exercise training program in the previous 6 months;
  • any condition that could interfere with the ability to exercise;
  • diagnosed psychiatric or cognitive disorders;
  • type I insulin-dependent diabetes mellitus;
  • excessively over-weight (BMI>35kg/m²);
  • other diagnosed cardiorespiratory disorders (e.g., chronic heart failure, peripheral artery disease).

研究组 & 干预措施

N-acetylcysteine

Active Comparator

Pharmacological treatment with N-acetylcysteine (NAC) pills

干预措施: N-acetylcysteine (Drug)

Placebo

Placebo Comparator

Treatment with placebo pills

干预措施: Placebo (Drug)

结局指标

主要结局

Plasma Redox Status - Circulating Glutathione

时间窗: pre-exercise value (day 4)

Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Exercise Capacity - Time to Exhaustion

时间窗: end-exercise value (Day 4)

Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

次要结局

  • Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)(Day 4)
  • Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)(Day 4)
  • Change in Central Cardiovascular Function - Cardiac Output(end-exercise value (Day 4))
  • Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)(Day 4)
  • Change in Pulmonary Ventilation - Minute Ventilation (VE)(end-exercise value (Day 4))

研究者

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

Dr. J. Alberto Neder

Principal Investigator

Queen's University

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