DRONABINOL for Chronic obstructive pulmonary disease

Inclusion criteria

• {"criterion_text":"- Refractory dyspnea despite optimal treatment"}
• {"criterion_text":"- COPD (GOLD 3,4)"}
• {"criterion_text":"- Breathlessness corresponding to mMRC score ≥ 3"}
• {"criterion_text":"- Informed written consent"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Cognitive relevant, of legal age"}
• {"criterion_text":"- Understands and speaks Danish"}
• {"criterion_text":"- For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial"}
• {"criterion_text":"- 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

• {"criterion_text":"- Ongoing infection or exacerbation of COPD within the last month (30 days)"}
• {"criterion_text":"- Regular treatment with THC or CBD within 1 month (30 days)"}
• {"criterion_text":"- Life expectancy less than 3 months (90 days)"}
• {"criterion_text":"- Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study"}

Primary endpoints

• {"endpoint_text":"- Comparison of Numeric Rating Scale (NRS) score of discomfort of daily breathlessness and daily interference of daily activities in relation to active treatment vs. placebo.","definition_or_measurement_approach":"Measured using Numeric Rating Scale (NRS) scores for daily breathlessness discomfort and daily interference with activities; comparison between active treatment (Dronabinol) and placebo."}
• {"endpoint_text":"- Comparison of NRS score of discomfort of daily breathlessness and daily interference of daily activities in relation to amount of THC level from the blood sample of the active treatment.","definition_or_measurement_approach":"NRS scores correlated with measured blood THC concentration from active treatment blood samples."}

Secondary endpoints

• {"endpoint_text":"- Difference in MDP (multidimensional dyspnea profile) in relation to active treatment vs. placebo","definition_or_measurement_approach":"MDP score comparison between active treatment and placebo."}
• {"endpoint_text":"- Difference in CAT (COPD assessment test) in relation to active treatment vs. placebo","definition_or_measurement_approach":"CAT score comparison between active treatment and placebo."}
• {"endpoint_text":"- Difference in CRQ (chronic respiratory disease questionnaire) in relation to active treatment vs. placebo","definition_or_measurement_approach":"CRQ score comparison between active treatment and placebo."}
• {"endpoint_text":"- Difference in HADS (Hospital Anxiety and Depression Scale) in relation to active treatment vs. placebo","definition_or_measurement_approach":"HADS score comparison between active treatment and placebo."}
• {"endpoint_text":"- Difference in MRC score (Medical Research Council) in relation to active treatment vs. placebo","definition_or_measurement_approach":"MRC score comparison between active treatment and placebo."}
• {"endpoint_text":"- Difference in ESS (Epworth sleepiness score) in relation to active treatment vs. placebo","definition_or_measurement_approach":"ESS score comparison between active treatment and placebo."}
• {"endpoint_text":"- Difference in Spirometry (FEV1, FVC, FEV1/FVC (ratio)) in relation to active treatment vs. placebo","definition_or_measurement_approach":"Spirometry measures (FEV1, FVC, FEV1/FVC) compared between active treatment and placebo."}
• {"endpoint_text":"- Difference in 6MWT (Six-minute walk test including BORG score) in relation to active treatment vs. placebo","definition_or_measurement_approach":"Six-minute walk test distance and BORG scores compared between active treatment and placebo."}
• {"endpoint_text":"- Difference in hair cortisol level in relation to active treatment vs. placebo","definition_or_measurement_approach":"Hair cortisol levels compared between active treatment and placebo."}
• {"endpoint_text":"- Difference in parameters from Empatica Embrace watch (such as continuous measurement of SpO2 (blood oxygen saturation), EDA (electrodermal activity), P (pulse rate), sleep recording, temperature and respiratory rate, activity counter) in relation to active treatment vs. placebo","definition_or_measurement_approach":"Continuous physiological parameters from Empatica Embrace (SpO2, EDA, pulse rate, sleep, temperature, respiratory rate, activity) compared between active treatment and placebo."}

Denmark

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

14-05-2024

Processing Time Days

15

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Lillebaelt Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Syddansk Universitet (University of Southern Denmark)","duties_or_roles":"Codes: 1,10,12,6 (as listed in sponsorDuties)","organisation_type":"Educational Institution"}
• {"country":"Denmark","full_name":"Glostrup Apotek","duties_or_roles":"Codes: 14 (as listed in sponsorDuties)","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Sygehus Lillebaelt Vejle Sygehus","duties_or_roles":"Codes: 14,4 (as listed in sponsorDuties)","organisation_type":"Hospital/Clinic/Other health care facility"}