BONG: Reducing severe Breathlessness with Dronabinol in the severe and very severe chronic obstructive pulmonary disease patient group
Overview
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Lillebaelt Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
This clinical trial study is a randomized, controlled, double blinded, crossover trial testing the pharmaceutical drug Dronabinol for patients with severe and very severe chronic obstrutive pulmonary disease (COPD). The study will investigate whether Dronabinol, containing the psychoactive compound Δ9-tetrahydrocannabinol from synthethic produced cannabis, relieves breathlessness in patients with COPD.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Difference in MDP (multidimensional dyspnea profile) in relation to active treatment vs. placebo
- Difference in CAT (COPD assessment test) in relation to active treatment vs. placebo
- Difference in CRQ (chronic respiratory disease questionnaire) in relation to active treatment vs. placebo
- Difference in HADS (Hospital Anxiety and Depression Scale) in relation to active treatment vs. placebo
- Difference in MRC score (Medical Research Council) in relation to active treatment vs. placebo
- Difference in ESS (Epworth sleepiness score) in relation to active treatment vs. placebo
- Difference in Spirometry (FEV1, FVC, FEV1/FVC (ratio)) in relation to active treatment vs. placebo
- Difference in 6MWT (Six-minute walk test including BORG score) in relation to active treatment vs. placebo
- Difference in hair cortisol level in relation to active treatment vs. placebo
- 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
Investigators
Coordinating investigator
Scientific
Lillebaelt Hospital