Comparison of Bronchodilation and Oxygenation Patterns Induced by Long-acting β2-agonists and Muscarinic Antagonists in Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tissue oxygenation (TcO2) change from baseline
研究概览
简要总结
The goal of this clinical trial was to compare the action of long-acting ß2-agonists (LABA-olodaterol) and muscarinic antagonists (LAMA-tiotropium) on tissue oxygenation in COPD considering their impact on proximal and peripheral ventilation and, eventually, on lung capillary volume. The hypothesis was that LABA would have a more peripheral effect than LAMA (due to the opposite gradient of their receptors) and better peripheral ventilation would result in a greater oxygenation.
Before and after LABA (visit 1) and LAMA (visit 2) inhalation, COPD participants were asked to perform single-breath washout and forced oscillation tests, double diffusion technique and spirometry, while transcutaneous oxygenation was continuously recorded.
详细描述
Slopes of He (SHe) and SF6 (SSF6) from single-breath washout test (SBWO) (assessing ventilation heterogeneities at the level of pre- and intra-acinar bronchioles, respectively) (quadruple model, LR6000 Logan-Sinclair, Rochester, UK), respiratory system resistance (R5, R5-R19) and reactance (X5, AX, Fres) from forced oscillation test (FOT) (Resmon Pro, ResTech, Italy), lung capillary volume (Vc) from double diffusion of NO and CO (DLNO/DLCO) (Hyp'Air compact, Medisoft, Dinant, Belgium), and FEV1 from spirometry (Zan®, Oberthulba, Germany) were evaluated before and after LABD administered via a spacer device: during the first visit, before, 30 minutes and 2 hours after inhalation of 4 puffs of 2,5 µg of olodaterol (LABA); during the second visit, before, 40 minutes and 2 hours after the administration of 4 puffs of 2,5 µg of tiotropium (LAMA). Transcutaneous oximetry (Perimed232©, Järfälla, Sweden) was monitored continuously during the 2 hours of each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •COPD diagnosis according to international criteria
排除标准
- •inability to perform the tests or to maintain the washout period
- •an exacerbation within the previous 6 weeks
- •a diagnosis of asthma or another chronic respiratory disease that could influence the results of the study
研究组 & 干预措施
LABA (olodaterol)
After 4-5 days washout period, during the first visit, participants received a long-acting beta2-agonist (LABA)
干预措施: LABA (Drug)
LAMA (tiotropium)
Two days after the first visit, during the second visit , participants received a long-acting muscarinic antagonist (LAMA)
干预措施: LAMA (Drug)
结局指标
主要结局
Tissue oxygenation (TcO2) change from baseline
时间窗: 30 (LABA)/40 (LAMA) minutes post-drug administration
Transcutaneous oxygen (TcO2) evaluated continuously with a transcutaneous oximeter
次要结局
- Resonant frequency (Fres) change from baseline(30 (LABA)/40 (LAMA) minutes post-drug administration)
- Peripheral resistance (R5-R19) change from baseline(30 (LABA)/40 (LAMA) minutes post-drug administration)
- Lung capillary volume (Vc) change from baseline(30 (LABA)/40 (LAMA) minutes post-drug administration)
- Slope of Helium (SHe) change from baseline(30 (LABA)/40 (LAMA) minutes post-drug administration)
- Area under reactance curve from 5 Hz (AX) change from baseline(30 (LABA)/40 (LAMA) minutes post-drug administration)
- Reactance at 5 Hz (X5) change from baseline(30 (LABA)/40 (LAMA) minutes post-drug administration)
- Forced Expiratory Volume in 1 Second (FEV1) change from baseline(30 (LABA)/40 (LAMA) minutes post-drug administration)
研究者
Silvia Perez Bogerd
Chest physician, head of the COPD and Pulmonary Rehabilitation Clinic
Erasme University Hospital