Back to resultsCAN BREATHE in COPD Trial
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD), Breathlessness, Exercise Intolerance
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Cannabis
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Cannabis, Marijuana
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.
Sites / Locations
- McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Cannabis
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing.
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.
Changes in cycle exercise endurance time.
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.
Secondary Outcome Measures
Changes in Spirometry
Spirometry will be performed before and 5-min after treatment administration
Changes in Impulse oscillometry
Impulse oscillometry will be performed before and 10-min after treatment administration
Changes in Physiological responses during exercise.
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.
Plasma cannabinoid levels.
Venous blood samples for the determination of circulating levels of cannabinoids will be collected before and 2-, 30-, 75-, and 180-min after vaporization
Psychoactive effects.
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.
Mood effects.
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.
Cognitive effects.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03060993
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Anticipated)
Primary Completion Date
January 1, 2018 (Anticipated)
Study Completion Date
April 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD), Breathlessness, Exercise Intolerance
Keywords
Cannabis, Marijuana
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Cannabis
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Intervention Description
Patients will be administered cannabis (THC/CBD) in vaporized form.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form.
Primary Outcome Measure Information:
Title
Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing.
Description
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.
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Title
Changes in cycle exercise endurance time.
Description
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.
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Secondary Outcome Measure Information:
Title
Changes in Spirometry
Description
Spirometry will be performed before and 5-min after treatment administration
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Title
Changes in Impulse oscillometry
Description
Impulse oscillometry will be performed before and 10-min after treatment administration
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Title
Changes in Physiological responses during exercise.
Description
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.
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Title
Plasma cannabinoid levels.
Description
Venous blood samples for the determination of circulating levels of cannabinoids will be collected before and 2-, 30-, 75-, and 180-min after vaporization
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Title
Psychoactive effects.
Description
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.
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Title
Mood effects.
Description
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.
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Title
Cognitive effects.
Description
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
Time Frame
Participants will be followed until all study visits are complete, an expected average of 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Abdallah, MSc.
Phone
514-934-1934
Ext
32465
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Abdallah, MSc.
Phone
514-934-1934
Ext
32465
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, Ph.D.
First Name & Middle Initial & Last Name & Degree
Jean Bourbeau, M.D.
First Name & Middle Initial & Last Name & Degree
Benjamin Smith, M.D.
First Name & Middle Initial & Last Name & Degree
Mark Ware, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30049223
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.
Results Reference
derived
Links:
URL
http://www.mcgill.ca/cerpl/
Description
Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University
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CAN BREATHE in COPD Trial
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