Clinical trial NCT06473701: Reducing Breathlessness With Dronabinol in COPD Patients
Official title: BONG: Reducing Severe Breathlessness With Dronabinol in the Severe and Very Severe Chronic Obstructive Pulmonary Disease Patient Group - A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: COPD
Breathlessness
Cannabis
Keywords: Randomized, Controlled, Double-blind, Crossover trial
Cannabis-based medicine
Cannabis
COPD
Breathlessness
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Odense Patient Data Explorative Network
name: University of Southern Denmark
name: University of Aarhus
First posted: 2024-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, controlled, double-blind, crossover trial
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: This study is a randomized, controlled, double-blind, crossover trial evaluating the effectiveness of the pharmaceutical drug Dronabinol in patients with severe and very severe COPD.

The researchers will compare the effects of Dronabinol with a placebo (an identical-looking substance that contains no active drug) to determine if Dronabinol reduces breathlessness in COPD patients.

After enrollment, study subjects will undergo four weeks of treatment with both Dronabinol and the placebo in a blinded and randomized sequence. There is a two-week washout period between treatments. During these treatment phases, subjects will complete questionnaires about their daily experiences of breathlessness and wear a watch that records various health parameters.

The study includes eight visits: the initial enrollment and follow-up checks every two weeks. At these visits, subjects undergo tests for lung function and walking distance, and complete health status questionnaires. Additionally, blood samples for THC levels and hair samples for cortisol analysis are collected.

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

Primary outcomes:
measure: Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
timeFrame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
measure: Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
timeFrame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
measure: Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
timeFrame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
measure: Correlation between breathlessness interference of daily activities rated on a numeric rating scale in relation to amount of THC blood level of the active treatment period
timeFrame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
Secondary outcomes:
measure: Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in COPD Assessment Test questionnaire score between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in Epworth Sleepiness Scale questionnaire score between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in the spirometry parameter forced expiratory volume in 1. second (FEV1) between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in the spirometry parameter forced vital capacity (FVC) between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in the spirometry parameter FEV1/FVC (ratio), between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in six-minute walk test(6MWT) between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference Borg dyspnea score conducted in relation to 6MWT between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in cortisol level in the hair samples between active treatment and placebo period
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Other outcomes:
measure: Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
measure: Difference in stand-to-sit-test between active treatment and placebo
timeFrame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital - A part of Lillebaelt Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: Medical Department, Vejle Hospital
name: Ole Hilberg, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: