Clinical trial NCT03060993: CAN BREATHE in COPD Trial
Official title: Effect of Inhaled Vaporized Cannabis on Pulmonary Function, Breathlessness and Exercise Tolerance in Symptomatic Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Breathlessness
Exercise Intolerance
Keywords: Cannabis
Marijuana
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A growing body of physiological evidence now exists to support a potential role for inhaled cannabis in the medical management of adults with chronic obstructive pulmonary disease (COPD), particularly as it may related to improving pulmonary function, alleviating the symptom of breathlessness and improving exercise endurance. The purpose of this randomized double-blind crossover trials is to evaluate the efficacy and physiological mechanism(s) of action of inhaled vaporized cannabis targeted to relief of physical activity-related breathlessness and exercise endurance in symptomatic patients with severe-to-very severe COPD.


Eligibility criteria: Inclusion Criteria:

* GOLD stage III or IV COPD (i.e., post-β2-agonist FEV1 of 50% predicted or less)
* Self-reported cigarette smoking history ≥10 pack yrs
* Currently taking long-acting beta-2 agonists and long-acting antimuscarinic agents (LABA/LAMAs) with or without an inhaled corticosteroid
* Willing to abstain from cannabis smoking for ≥15 days prior to study participation (if applicable)
* Willing to abstain from non-study related cannabis smoking throughout the study period (if applicable)
* No change in medication dosage or frequency of administration, with no exacerbations or hospitalizations in the preceding 4 weeks

Exclusion Criteria:

* Presence of active and/or uncontrolled cardiopulmonary and/or musculoskeletal disease other than COPD that could contribute to breathlessness and exercise intolerance
* Hepatic or renal impairment
* Psychiatric history (other than depression and/or anxiety)
* History of epilepsy or convulsions;
* Lung cancer
* History of sensitivity to cannabis
* Use of levodopa, sildenafil and/or fentanyl
* Use of ketoconazole
* Use of regular high dose opioids (i.e., 30 mg of oral morphine equivalents/day)
* Known or suspected history of addiction/substance abuse based on CAGE-AID and SISAP scores (\*note, patients may be recruited if they have a history of smoking cannabis)
* Positive urine toxicology for cannabinoids on screening
* Positive pregnancy urine test
* Subject cannot arrange to be accompanied home by a family member and/or friend during each treatment visit.

Primary outcomes:
measure: Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing.
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
measure: Changes in cycle exercise endurance time.
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Secondary outcomes:
measure: Changes in Spirometry
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
measure: Changes in Impulse oscillometry
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
measure: Changes in Physiological responses during exercise.
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
measure: Plasma cannabinoid levels.
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
measure: Psychoactive effects.
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
measure: Mood effects.
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
measure: Cognitive effects.
timeFrame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Dennis Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdallah SJ, Smith BM, Ware MA, Moore M, Li PZ, Bourbeau J, Jensen D. Effect of Vaporized Cannabis on Exertional Breathlessness and Exercise Endurance in Advanced Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Ann Am Thorac Soc. 2018 Oct;15(10):1146-1158. doi: 10.1513/AnnalsATS.201803-198OC.