Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Low-frequency (LF)/High-frequency (HF) ratio in supine position during a tilt table test after bronchodilators inhalation
研究概览
简要总结
The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to quantify the possible deleterious effect on the cardiac autonomic nervous system control of two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.
详细描述
This is a cross-over study with randomization in terms of 4 treatments: two long-acting muscarinic antagonists (tiotropium and glycopyrronium), one long-acting beta-adrenoceptor agonist(indacaterol) and placebo.
Each subject will pass 4 experimental random sessions, separated by at least 48 hours given the pharmacokinetic properties of the drugs tested. During each of the 4 sessions, blood pressure will be measured. Drugs inhaled by the patient will be prepared and administered by the nurse according to the randomization schedule. Patients and investigators will be blinded regarding the administered drug/placebo (anonymized inhaler). After 15 minutes (at rest, at neutral temperature), patients will have continuous measurement of blood pressure and heart rate (by a sphygmomanometer) (1) in supine position and (2) after a passive tilt test on a tilt test table.
A flow-volume loop (BDV) will be performed after the tilt table test (measurement of Forced expiratory volume in 1 second (FEV1) and FVC).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with FEV1 / FVC <70%
排除标准
- •beta blocker
- •supraventricular rhythm disorder
- •previous history of respiratory disease other than COPD
- •autonomic dysfunction
- •dysautonomia
- •renal failure
- •long-term oxygen therapy
- •history of psychiatric illness
研究组 & 干预措施
Arm 1
The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo
干预措施: Indacaterol (Drug)
Arm 1
The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo
干预措施: Glycopyrronium (Drug)
Arm 1
The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo
干预措施: Tiotropium (Drug)
Arm 1
The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo
干预措施: Placebo (Drug)
Arm 1
The patients receive once a week during 4 weeks, in the order: indacaterol, tiotropium, glycopyrronium and placebo
干预措施: photoplethysmography (Procedure)
Arm 2
The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol
干预措施: Indacaterol (Drug)
Arm 2
The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol
干预措施: Glycopyrronium (Drug)
Arm 2
The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol
干预措施: Tiotropium (Drug)
Arm 2
The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol
干预措施: Placebo (Drug)
Arm 2
The patients receive once a week during 4 weeks, in the order: tiotropium, glycopyrronium, placebo and indacaterol
干预措施: photoplethysmography (Procedure)
Arm 3
The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,
干预措施: Indacaterol (Drug)
Arm 3
The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,
干预措施: Glycopyrronium (Drug)
Arm 3
The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,
干预措施: Tiotropium (Drug)
Arm 3
The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,
干预措施: Placebo (Drug)
Arm 3
The patients receive once a week during 4 weeks, in the order: glycopyrronium, placebo, indacaterol and tiotropium,
干预措施: photoplethysmography (Procedure)
Arm 4
The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium
干预措施: Indacaterol (Drug)
Arm 4
The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium
干预措施: Glycopyrronium (Drug)
Arm 4
The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium
干预措施: Tiotropium (Drug)
Arm 4
The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium
干预措施: Placebo (Drug)
Arm 4
The patients receive once a week during 4 weeks, in the order: placebo, indacaterol and tiotropium and glycopyrronium
干预措施: photoplethysmography (Procedure)
结局指标
主要结局
Low-frequency (LF)/High-frequency (HF) ratio in supine position during a tilt table test after bronchodilators inhalation
时间窗: 10 minutes
For each patient, the LF/HF ratio after inhalation of an active drug (indacaterol or glycopyrronium or tiotropium) will be compared to LF / HF ratio measured after inhalation of a placebo.
次要结局
- Value of HF (gross value then normalized according to the average R-R interval) during a tilt table tes(20 minutes)
- RMSSD (Root Mean Square of the Successive Differences) index during a tilt table test(20 minutes)
- Variability in blood pressure during a tilt table test(20 minutes)
- Slope of baroreflex in supine position(10 minutes)
- LF / HF ratio derived from the spectral analysis of R-R intervals measured after verticalisation during a tilt table test(10 minutes)
- Total spectral power during a tilt table tes(20 minutes)