Effect of L-menthol on Breathlessness and Exercise Capacity in Interstitial Lung Disease: a Randomized Crossover Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 20
- 试验地点
- 2
- 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 and exercise capacity in patients with Interstitial lung disease (ILD).
详细描述
Dyspnea is a cardinal symptom in patients with interstitial lung disease (ILD), often triggered by daily-life physical activities. 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 ILD 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 ILD.
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
- •Physician diagnosis of fibrosing ILD according to international guidelines
- •age 18 years or older
- •able to cycle
- •able to understand and talk Swedish to participate in the study procedures, as judged by the Investigators.
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
L-Menthol
In the trial, prior to performing submaximal cardio-pulmonary exercise testing (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: During submaximal test, at isotime during day 2 and day 3.
The difference between treatment conditions in dyspnea intensity at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced.
次要结局
- Dyspnea unpleasantness(During submaximal test, at iso-time during day 2 and day 3.)
- Total time(At the end of submaximal test during day 2 and day 3.)
- Exercise capacity(Submaximal test during day 2 and day 3.)
- Peak dyspnea intensity(During submaximal test, at peak during day 2 and day 3.)
- Leg fatigue(During submaximal test at day 2 and day 3.)
- Ventilatory efficacy(During submaximal test at day 2 and day 3.)
- Saturation(During submaximal test at day 2 and day 3.)
- Stop reason(During submaximal test at day 2 and day 3.)
- Adverse events(through study completion, an average of 1 week.)
- Respiratory exchange ratio(During the submaximal test at day 2 and day 3.)
- Heart rate(During the submaximal test at day 2 and day 3.)
- Breathing frequency(During the submaximal test at day 2 and day 3.)
- Minute ventilation(During the submaximal test at day 2 and day 3.)
- Tidal volume (VT)(During the submaximal test at day 2 and day 3.)
- Ventilatory reserve(During the submaximal test at day 2 and day 3.)