使用屈大麻酚减少慢性阻塞性肺病患者的呼吸困难 (BONG)
BONG：用屈大麻酚减少严重和极严重慢性阻塞性肺疾病患者组的严重呼吸困难 - 一项随机、双盲、安慰剂对照、交叉研究
This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).
研究概览
详细说明
This study is a randomized, controlled, double-blind, crossover trial evaluating the effectiveness of the pharmaceutical drug Dronabinol in patients with severe and very severe COPD.
The researchers will compare the effects of Dronabinol with a placebo (an identical-looking substance that contains no active drug) to determine if Dronabinol reduces breathlessness in COPD patients.
After enrollment, study subjects will undergo four weeks of treatment with both Dronabinol and the placebo in a blinded and randomized sequence. There is a two-week washout period between treatments. During these treatment phases, subjects will complete questionnaires about their daily experiences of breathlessness and wear a watch that records various health parameters.
The study includes eight visits: the initial enrollment and follow-up checks every two weeks. At these visits, subjects undergo tests for lung function and walking distance, and complete health status questionnaires. Additionally, blood samples for THC levels and hair samples for cortisol analysis are collected.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Region Syddanmark
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Vejle、Region Syddanmark、丹麦、7100
- Vejle Hospital - A part of Lillebaelt Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Refractory dyspnea despite optimal treatment
- COPD (GOLD 3,4)
- Breathlessness corresponding to mMRC score ≥ 3
- Informed written consent
- Age ≥ 18 years
- Cognitive relevant, of legal age
- Understands and speaks Danish
- For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial
- For fertile and sexually active subjects: use of safe contraception during medication intake and 4 weeks after: intrauterine device (IUD) or hormonal contraception (oral contraceptive pill, implant, transdermal patch, vaginal ring or depot injection).
Exclusion Criteria:
- Ongoing infection or exacerbation of COPD within the last month (30 days)
- Regular treatment with THC or CBD within 1 month (30 days)
- Life expectancy less than 3 months (90 days)
- Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19
- History of or current evidence of significant medical or psychiatric disorder that is considered by the investigator to put the subject at greater risk of experiencing an adverse event
- Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Dronabinol 20 mg, then placebo
In this arm, the study subject will first receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
其他名称：
Dronabinol-matched placebo capsule containing no active substance. |
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安慰剂比较：Placebo, then dronabinol 20 mg
In this arm, the study subject will first receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
其他名称：
Dronabinol-matched placebo capsule containing no active substance. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
大体时间：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
大体时间：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
大体时间：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Correlation between breathlessness interference of daily activities rated on a numeric rating scale in relation to amount of THC blood level of the active treatment period
大体时间：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assesses different dimensions of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in COPD Assessment Test questionnaire score between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assesses the severity of physical COPD symptoms. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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A HRQL tool which incorporates patient perceptions of both physical and emotional health. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assess anxiety and depression symptoms in medical patients. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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A simple and valid method of categorizing patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Epworth Sleepiness Scale questionnaire score between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assesses person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in the spirometry parameter forced expiratory volume in 1. second (FEV1) between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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The FEV1 indicates the lung tissue's ability to release air during the first second of exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in the spirometry parameter forced vital capacity (FVC) between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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The FVC indicates the lung tissue's ability to release air during the entire exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in the spirometry parameter FEV1/FVC (ratio), between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Can indicate an obstructive pattern in the exhalation which are used in the diagnosis of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in six-minute walk test(6MWT) between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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6 minutes walking test measures breathlessness and performance ability. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference Borg dyspnea score conducted in relation to 6MWT between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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A numeric scale from 0 (no breathlessness) to 10 (extremely strong breathlessness) but not limited to 10 if subjects feel breathlessness above 10 |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in cortisol level in the hair samples between active treatment and placebo period
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Measurement of stress through cortisol levels in the hair. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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For several days in each treatment period we continuously measure blood oxygen saturation, electrodermal activity, pulse rate, sleep recording, temperature, respiratory rate, and activity counter. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in stand-to-sit-test between active treatment and placebo
大体时间：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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A measurement for physical capability until breathlessness. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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合作者和调查者
合作者
调查人员
- 首席研究员：Ole Hilberg, Prof., MD、Medical Department, Vejle Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2024-513593-22-00
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
It is the plan to share SAP when this is finalized. It is undecided whether CSR and analytic code will be shared on a platform or available on reasonable request.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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