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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
30
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
Dronabinol-matched placebo capsule containing no active substance.
Vejle Hospital - A part of Lillebaelt Hospital
Vejle, Region Syddanmark, Denmark
RECRUITINGDifference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
Time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Assesses different dimensions of COPD.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Vejle Hospital
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Difference in COPD Assessment Test questionnaire score between active treatment and placebo period
Assesses the severity of physical COPD symptoms.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period
A HRQL tool which incorporates patient perceptions of both physical and emotional health.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period
Assess anxiety and depression symptoms in medical patients.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period
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.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in Epworth Sleepiness Scale questionnaire score between active treatment and placebo period
Assesses person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in the spirometry parameter forced expiratory volume in 1. second (FEV1) between active treatment and placebo period
The FEV1 indicates the lung tissue's ability to release air during the first second of exhalation.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in the spirometry parameter forced vital capacity (FVC) between active treatment and placebo period
The FVC indicates the lung tissue's ability to release air during the entire exhalation.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in the spirometry parameter FEV1/FVC (ratio), between active treatment and placebo period
Can indicate an obstructive pattern in the exhalation which are used in the diagnosis of COPD.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in six-minute walk test(6MWT) between active treatment and placebo period
6 minutes walking test measures breathlessness and performance ability.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference Borg dyspnea score conducted in relation to 6MWT between active treatment and placebo period
A numeric scale from 0 (no breathlessness) to 10 (extremely strong breathlessness) but not limited to 10 if subjects feel breathlessness above 10
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Difference in cortisol level in the hair samples between active treatment and placebo period
Measurement of stress through cortisol levels in the hair.
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)