Reducing Breathlessness With Dronabinol in COPD Patients
NCT Number: NCT06473701
Acronym: BONG
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: COPD|Breathlessness|Cannabis
Interventions: DRUG: Dronabinol 2.5mg Capsule|DRUG: Placebo
Sponsor: Vejle Hospital
Collaborators: Region of Southern Denmark|Odense Patient Data Explorative Network|University of Aarhus|University of Southern Denmark
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2026-07

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).

Primary Outcome Measures: 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, Assessed daily in the baseline period and through both treatment periods. Up to 70 days|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, Assessed daily in the baseline period and through both treatment periods. Up to 70 days|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, Assessed daily in the baseline period and through both treatment periods. Up to 70 days|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, Assessed daily in the baseline period and through both treatment periods. Up to 70 days
Secondary Outcome Measures: Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period, Assesses different dimensions of COPD., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in COPD Assessment Test questionnaire score between active treatment and placebo period, Assesses the severity of physical COPD symptoms., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|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., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period, Assess anxiety and depression symptoms in medical patients., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period, A simple and valid method of categorizing patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in Epworth Sleepiness Scale questionnaire score between active treatment and placebo period, Assesses person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in the spirometry parameter forced expiratory volume in 1. second (FEV1) between active treatment and placebo period, The FEV1 indicates the lung tissue's ability to release air during the first second of exhalation., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in the spirometry parameter forced vital capacity (FVC) between active treatment and placebo period, The FVC indicates the lung tissue's ability to release air during the entire exhalation., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in the spirometry parameter FEV1/FVC (ratio), between active treatment and placebo period, Can indicate an obstructive pattern in the exhalation which are used in the diagnosis of COPD., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in six-minute walk test(6MWT) between active treatment and placebo period, 6 minutes walking test measures breathlessness and performance ability., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference Borg dyspnea score conducted in relation to 6MWT between active treatment and placebo period, A numeric scale from 0 (no breathlessness) to 10 (extremely strong breathlessness) but not limited to 10 if subjects feel breathlessness above 10, Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in cortisol level in the hair samples between active treatment and placebo period, Measurement of stress through cortisol levels in the hair., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Other Outcome Measures: 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., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)|Difference in stand-to-sit-test between active treatment and placebo, A measurement for physical capability until breathlessness., Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)