NCT06473701 Reducing Breathlessness With Dronabinol in COPD Patients
| NCT ID | NCT06473701 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vejle Hospital |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 30 participants in total. It began in 2025-02-26 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ole Hilberg, Prof., MD
PRINCIPAL INVESTIGATOR
Medical Department, Vejle Hospital
Frequently Asked Questions
Who can join the NCT06473701 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06473701 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 30 participants.
Is NCT06473701 currently recruiting?
Yes, NCT06473701 is actively recruiting participants. Contact the research team at swolsing@health.sdu.dk for enrollment information.
Where is the NCT06473701 trial being conducted?
This trial is being conducted at Vejle, Denmark.
Who is sponsoring the NCT06473701 clinical trial?
NCT06473701 is sponsored by Vejle Hospital. The principal investigator is Ole Hilberg, Prof., MD at Medical Department, Vejle Hospital. The trial plans to enroll 30 participants.
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