Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT03060993
CAN BREATHE in COPD Trial
A Phase 2 study testing Cannabis in people with Chronic Obstructive Pulmonary Disease (COPD) and Breathlessness, run by McGill University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Breathlessness, Exercise Intolerance
- What is being tested?
- Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 30 Apr 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sara Abdallah, MSc. contact
Canada1 site
McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Sara Abdallah, MSc., 514-934-1934 ext. 32465
Dennis Jensen, Ph.D.
About this study
Official title: Effect of Inhaled Vaporized Cannabis on Pulmonary Function, Breathlessness and Exercise Tolerance in Symptomatic Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD)
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.
- Being tested
- Cannabis, Placebo
- Keywords
- Cannabis, Marijuana
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Patients will be administered cannabis (THC/CBD) in vaporized form.
PlaceboDrug
Patients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Cannabis | Active comparator | 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. Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
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.
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Secondary outcomes (7)
Changes in Spirometry
Spirometry will be performed before and 5-min after treatment administration
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Changes in Impulse oscillometry
Impulse oscillometry will be performed before and 10-min after treatment administration
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
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.
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
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
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
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.
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
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.
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
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
Measured: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060993
- Sponsor's protocol ID
- CNBS001
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30049223
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhaled Vaporized Cannabis on Pulmonary Function, Breathlessness and Exercise Tolerance in Symptomatic Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03060993
- Acronym / sponsor ID
- CNBS001
- Keywords
- Cannabis, Marijuana
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo35 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 | Active comparator | Drug: Cannabis35 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisPatients will be administered cannabis (THC/CBD) in vaporized form. | Drug | Cannabis |
| PlaceboPatients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form. | Drug | Placebo |
Primary outcome
Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing.
Time frame: 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.
Changes in cycle exercise endurance time.
Time frame: 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.
7 secondary outcomes
Changes in Spirometry
Time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Changes in Impulse oscillometry
Time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Changes in Physiological responses during exercise.
Time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Plasma cannabinoid levels.
Time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Psychoactive effects.
Time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Mood effects.
Time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Cognitive effects.
Time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 30049223Abdallah 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.
- Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Abdallah, MSc. contact
Dennis Jensen, Ph.D. principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis in people with Chronic Obstructive Pulmonary Disease (COPD) and Breathlessness, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Abdallah, MSc. (514-934-1934 ext. 32465), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing. (time frame: Participants will be followed until all study visits are complete, an expected average of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.