Reducing Breathlessness With Dronabinol in COPD Patients

Launched by VEJLE HOSPITAL · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether a medication called Dronabinol, which contains a compound from cannabis, can help reduce severe breathlessness in people with chronic obstructive pulmonary disease (COPD). COPD is a lung condition that makes it hard to breathe, and this study focuses on patients who still experience significant breathlessness, even though they are receiving the best available treatment. The trial is currently recruiting participants aged 18 and older, who can understand and speak Danish, and who have a specific level of breathing difficulty.

To be eligible for this study, participants should have trouble breathing that doesn't get better with standard treatments and have been diagnosed with severe or very severe COPD. They should also be in generally good health, without recent infections or significant medical issues that could complicate their participation. If you join the trial, you can expect to take the medication for a set period and attend follow-up appointments to monitor your progress. It's important to note that women who can become pregnant will need to use reliable contraception during the study. This trial aims to provide insight into new ways to help manage breathlessness in COPD patients, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• 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