Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Breathlessness intensity
研究概览
简要总结
The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).
详细描述
Breathelssness (Dyspnea) is a cardinal symptom in patients with chronic obstructive pulmonary disease (COPD), often triggered by daily-life physical activities. Despite optimal treatment of the underlying disease, many patients still suffer from chronic and disabling dyspnea for many years, leading to exercise intolerance, and worse morbidity and mortality. To date, an effective pharmacologic treatment to relieve chronic dyspnea is lacking. Recent pilot data support that inhaled L-menthol can markedly decrease laboratory-induced dyspnea in COPD patients, likely through increased afferent feedback of airflow in the airways by inducing a cooling sensation through olfactory stimulation. The aim of this study is therefore to assess the effectiveness and mechanisms of inhaled menthol for relief of chronic dyspnea in patients with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
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
- •The subject has given written consent to participate in the study
- •Diagnosis of COPD confirmed by spirometry and a FEV1 < 80% of predicted post bronchodilator at baseline
- •age 18 years or older
- •able to cycle
- •able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator.
排除标准
- •Resting peripheral oxygen saturation (SpO2) < 92%
- •hospitalization or clinical instability during the last four weeks
- •treatment with supplementary oxygen at rest or during exercise
- •contraindication to exercise testing in accordance with clinical practice guidelines
- •expected survival shorter than six months as judged by the Investigator
- •medical conditions including congestive heart failure, acute coronary artery disease, neuromuscular diseases, severe psychiatric illness, and olfaction disorder.
研究组 & 干预措施
Menthol
In the trial, 30 minutes prior to performing submaximal CPET, participants will be administered, L-menthol patch which will be attached to the inside of a facemask that is connected to the breathing circuit.
干预措施: L-menthol (Drug)
Placebo
For placebo, the patch will contain a similarly patch with strawberry scent.
干预措施: Placebo (Other)
结局指标
主要结局
Breathlessness intensity
时间窗: Through study completion, up to 1 year
The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.
次要结局
- Tidal volume (VT)(Through study completion, up to 1 year)
- Cardiac reserve(Through study completion, up to 1 year)
- Leg discomfort(Through study completion, up to 1 year)
- Anaerobic threshold(Through study completion, up to 1 year)
- Stop reason(Through study completion, up to 1 year)
- Adverse events(Through study completion, up to 1 year)
- Dyspnea unpleasantness(Through study completion, up to 1 year)
- Total time(Through study completion, up to 1 year)
- Work load(Through study completion, up to 1 year)
- Exercise capacity(Through study completion, up to 1 year)
- Minute ventilation(Through study completion, up to 1 year)
- Ventilatory reserve(Through study completion, up to 1 year)
- Inspiratory capacity(Through study completion, up to 1 year)
- Breathing frequency(Through study completion, up to 1 year)
- Peak dyspnea intensity(Through study completion, up to 1 year)
- Ventilatory efficacy(Through study completion, up to 1 year)
- Respiratory exchange ratio(Through study completion, up to 1 year)
- Saturation(Through study completion, up to 1 year)