Tilray Announces Support for Clinical Trial Evaluating Medical Cannabis Efficacy in COPD Patients
The effects of vaporized cannabis on symptoms associated with chronic obstructive pulmonary disease (COPD) are the target of a new clinical trial that stems from a partnership between medical cannabis products company Tilray and the Research Institute of the McGill University Health Centre (RI-MUHC) in Montreal, Canada.
The company estimates that 45–90% of adults with advanced COPD suffer from chronic and impairing breathlessness related to physical activity despite optimal treatment of their lung disease with bronchodilators or corticosteroids.
The Phase 2 study titled, “CAN BREATHE in COPD Trial,” (NCT03060993), will study the efficacy of medical cannabis on breathlessness and exercise tolerance in people with advanced COPD. One patient group will receive 35 mg of cannabis (tetrahydrocannabinol/cannabidiol) in vaporized form, and another will receive a placebo.
Primary outcomes include changes in the intensity ratings of perceived breathlessness during cycle exercise testing and changes in cycle exercise endurance.
Secondary outcomes include changes in spirometry (a test assessing lung function), changes in impulse oscillometry (a measure of pulmonary resistance and reactance), changes in physiological responses during exercise, plasma cannabinoid levels, psychoactive effects, mood effects, and cognitive effects.
Dennis Jensen and Jean Bourbeau will lead the trial’s research team at the McConnel Centre for Innovative Medicine at RI-MUHC.
“Adjunct therapies targeted to relieve breathlessness and improved exercise tolerances are needed to enhance health outcomes for adults with advanced COPD, and medical cannabis is a potential therapy of interest,” Jensen said in a press release.
Recruitment of 20 participants already is underway. The trial is expected to be concluded by April 30, 2018. More information about the trial is available here.
“Tilray is proud to support this important research,” said Catherine Jacobson, director of clinical research at Tilray. “If we find that vaporized cannabis is safe, well-tolerated, and effective, we can conduct further research to help people with COPD and other medical conditions manage their symptoms effectively.”
COPD is a leading cause of morbidity, mortality, and socioeconomic burden in Canada and around the world. The management of COPD symptoms is crucial for patients to ensure that their condition remains stable and that quality of life is maintained.