Dronabinol 2.5mg Capsule: Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
Placebo: Dronabinol-matched placebo capsule containing no active substance.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo — Assessed daily in the baseline period and through both treatment periods. Up to 70 days Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo — Assessed daily in the baseline period and through both treatment periods. Up to 70 days Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period — Assessed daily in the baseline period and through both treatment periods. Up to 70 days Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
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 — Assessed daily in the baseline period and through both treatment periods. Up to 70 days Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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