Reducing Breathlessness With Dronabinol in COPD Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVejle Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Refractory dyspnea despite optimal treatment
COPD (GOLD 3,4)
Breathlessness corresponding to mMRC score ≥ 3
Informed written consent
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Dronabinol 2.5mg Capsule
DrugDronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
Placebo
DrugDronabinol-matched placebo capsule containing no active substance.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Dronabinol 20 mg, then placeboExperimental treatment 2 interventions
Group B: Placebo, then dronabinol 20 mgPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
Time frame
Assessed daily in the baseline period and through both treatment periods. Up to 70 days2
Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
Time frame
Assessed daily in the baseline period and through both treatment periods. Up to 70 days3
Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
Time frame
Assessed daily in the baseline period and through both treatment periods. Up to 70 days4
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
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
Time frame
Assessed daily in the baseline period and through both treatment periods. Up to 70 daysSecondary outcomes
1
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Assesses different dimensions of COPD.
Time frame
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)2
Difference in COPD Assessment Test questionnaire score between active treatment and placebo period
Assesses the severity of physical COPD symptoms.
Time frame
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)3
Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period
A HRQL tool which incorporates patient perceptions of both physical and emotional health.
Time frame
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)4
Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period
Assess anxiety and depression symptoms in medical patients.
Time frame
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)Other outcomes
1
Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
For several days in each treatment period we continuously measure blood oxygen saturation, electrodermal activity, pulse rate, sleep recording, temperature, respiratory rate, and activity counter.
Time frame
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)2
Difference in stand-to-sit-test between active treatment and placebo
A measurement for physical capability until breathlessness.
Time frame
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vejle Hospital
Lead sponsor
Region of Southern Denmark
Collaborator
Odense Patient Data Explorative Network
Collaborator
University of Southern Denmark
Collaborator
University of Aarhus
Collaborator
Source ClinicalTrials.gov