CAN BREATHE in COPD Trial
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)BreathlessnessExercise Intolerance
- Interventions
- Drug: Placebo
- Registration Number
- NCT03060993
- Lead Sponsor
- McGill University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo 35 mg of tetrahydrocannabinol/cannabidiol (LT1.0/LT1.0 %) in vaporized form. Placebo will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L. Cannabis Cannabis 35 mg of cannabis (tetrahydrocannabinol/cannabidiol; 18.0/LT1.0 %) in vaporized form. THC/CBD will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L.
- Primary Outcome Measures
Name Time Method Changes in cycle exercise endurance time. Participants will be followed until all study visits are complete, an expected average of 4 weeks Exercise endurance time will be defined as the duration of loaded pedaling during the constant-load cycle exercise testing performed at 75% of peak incremental power output.
Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing. Participants will be followed until all study visits are complete, an expected average of 4 weeks Patients will be required to rate the intensity of their breathlessness using Borg's modified 0-10 category ratio scale every 2-minutes during cycle exercise testing.
- Secondary Outcome Measures
Name Time Method Changes in Spirometry Participants will be followed until all study visits are complete, an expected average of 4 weeks Spirometry will be performed before and 5-min after treatment administration
Changes in Physiological responses during exercise. Participants will be followed until all study visits are complete, an expected average of 4 weeks Gas exchange, cardiovascular and breathing pattern variables will be collected breath-by-breath and averaged in 30-sec epochs during incremental and constant-load cycle exercise tests.
Mood effects. Participants will be followed until all study visits are complete, an expected average of 4 weeks Mood effects of cannabis will be evaluated during each treatment visit using 100-mm visual analogue scale (VAS). Mood effects will be evaluated before and 45-min after treatment administration.
Changes in Impulse oscillometry Participants will be followed until all study visits are complete, an expected average of 4 weeks Impulse oscillometry will be performed before and 10-min after treatment administration
Psychoactive effects. Participants will be followed until all study visits are complete, an expected average of 4 weeks Psychoactive effects of cannabis will be evaluated during each treatment visit using 100-mm visual analogue scale (VAS). Psychoactive effects will be evaluated before and 45-min after treatment administration.
Cognitive effects. Participants will be followed until all study visits are complete, an expected average of 4 weeks Cognitive effects will be measured during each treatment visit using the mini-mental state exam. The mini-mental state exam will be administered before and 45-min after treatment administration
Plasma cannabinoid levels. Participants will be followed until all study visits are complete, an expected average of 4 weeks Venous blood samples for the determination of circulating levels of cannabinoids will be collected before and 2-, 30-, 75-, and 180-min after vaporization
Trial Locations
- Locations (1)
McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
🇨🇦Montreal, Quebec, Canada