Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry.
研究概览
简要总结
Menthol inhalation (MI) is a novel and promising treatment option for acute relief of dyspnea, however, the underlying ventilatory and/or neural related mechanisms for this relief in symptoms remain unknown. The overall aim of this research project is to systematically examine the mechanisms of dyspnea relief from MI in healthy individuals and those with COPD.
详细描述
The project is structured in 5 work packages (WP), each including a different sample of healthy volunteers (WP1, 2) or patients with COPD (WP3, 4, 5), respectively with a 1:1 female/male ratio in each WP. Each WP will be single-blind, placebo-controlled cross-over trial to investigate the effects of MI compared to placebo in healthy volunteers during resistive loaded breathing (WP1), in healthy volunteers during cycling exercise (WP2), in people with COPD who have dyspnea at rest (WP3), and in people with COPD during cycling exercise (WP4, 5).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years of age or older
- •Able to speak, read, and write Dutch or English
- •Normal pulmonary function: forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio>0.70; FEV1≥80%predicted (WP1 and 2 only)
- •Non-smoker or former smokers (smoke-free ≥12 months prior to enrolment) (WP1 and 2 only)
- •Clinically stable COPD (based on clinical judgment of the study physician that have not had exacerbations requiring escalation of medical therapy (i.e., short course of oral corticosteroids or antibiotics) within the preceding 14 days (WP3 and 4 only)
排除标准
- •Contraindication to exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease; see Table 4 from ERS/ATS consensus statement)
- •Significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could influence dyspnea and/or impair exercise capacity (with the exception of COPD in WP3 and 4)
- •Body mass index <18.5 or >35 kg/m2
- •An ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
- •Severe facial trauma including cribriform plate disruption (bone separating brain from nasal cavity)
- •Allergies to latex and sensitivities to local anesthetics
- •Inability to give informed consent, including those with significant cognitive impairment
- •Alcohol consumption within 12 hours of study visit
- •Current smoker*
- •History of early menopause (age <45 years)
- •Pregnancy or desire to become pregnant while in trial
结局指标
主要结局
Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry.
时间窗: 1 week
RREPs will be measured using an electroencephalogram (EEG) sensor cap connected to a high-density 129 channel EEG system during breathing trials and exercise tests. Inspiration will briefly be interrupted for 150 milliseconds every two to six breaths by activation of the occluder, which induces the RREP in the EEG signal.
次要结局
未报告次要终点