Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark – a study protocol

Abstract Introduction: Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of Δ9-tetrahydrocannabinol (Δ9-THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo. Methods: This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or