Reducing Breathlessness With Dronabinol in COPD Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVejle Hospital
About this trial
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 criteria
Qualifiers
Refractory dyspnea despite optimal treatment
COPD (GOLD 3,4)
Breathlessness corresponding to mMRC score ≥ 3
Informed written consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dronabinol 2.5mg Capsule
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vejle Hospital
Lead sponsor
Region of Southern Denmark
Collaborator
Odense Patient Data Explorative Network
Collaborator
University of Southern Denmark
Collaborator
University of Aarhus
Collaborator
Source ClinicalTrials.gov