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临床试验/NCT02989935
NCT02989935进行中(未招募)4 期

RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD

University of Calgary2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Parasternal EMG change

研究概览

简要总结

This study examines the effect of the ultra long acting beta agonist/corticosteroid bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles and ventilation in adults with severe bronchitis or emphysema (COPD).

详细描述

In adults with severe, minimally reversible bronchitis or emphysema (COPD), there is progressive hyperinflation of the lungs with associated flattening and inefficiency of the major respiratory muscle, the diaphragm. These changes limit physical activity and exercise, and provoke shortness of breath - dyspnea.

These debilitating symptoms are often significantly lessened with ultra long acting combination bronchodilators, even in adults where the bronchodilator does not produce any measurable improvement in either airflow or lung hyperinflation.

This symptomatic improvement in adults with severe, minimally reversible COPD may occur because of a direct benefit of the bronchodilator on respiratory muscles and ventilation.

This study examines the effect of the ultra long acting bronchodilator fluticasone furoate/vilanterol trifenatate upon the upper anterior chest wall respiratory muscles (parasternals), the diaphragm, and breathing pattern.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • ambulatory, stable severe COPD (GOLD Class III-IV)
  • on long acting bronchodilator therapy
  • compliant with use of prescribed medications
  • fit for minor surgical procedure including intravenous sedation

排除标准

  • hypersensitivity to milk proteins
  • hypersensitive to fluticasone furoate/vilanterol formulation
  • angina or substantial cardiovascular risk
  • exacerbation of COPD within the preceding 2 months
  • significant non-respiratory system disease

结局指标

主要结局

Parasternal EMG change

时间窗: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.

Change in moving averaged, EMG continuously recorded from the parasternal intercostal muscle.

Minute ventilation change

时间窗: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.

Minute ventilation will be averaged and compared, before and then 2 hours after the bronchodilator inhalation.

Pressure change with phrenic stimulation

时间窗: 2 hours after fluticasone furoate/vilanterol bronchodilator inhalation.

Change in recorded mouth pressure during magnetic stimulation of the phrenic nerves.

次要结局

未报告次要终点

研究者

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

Paul Easton

Assoc.Prof. University of Calgary

University of Calgary

研究点 (2)

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