RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD
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
- 否
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
Paul Easton
Assoc.Prof. University of Calgary
University of Calgary
